A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active Comparator Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration

This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab 100 mg/mL delivered Q24W via the PDS implant compared with ranibizumab 0.5 mg delivered as a Q4W intravitreal injection in Chinese patients with nAMD.

Start Date28 Jun 2024

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

CTR20222633 / RecruitingPhase 3

一项在中国新生血管性年龄相关性黄斑变性患者中评估雷珠单抗眼内港式给药系统的有效性、安全性和药代动力学特征的III 期、多中心、随机、视力评估员设盲、阳性对照研究

[Translation] A Phase III, multicenter, randomized, visual assessor-blinded, active-controlled study to evaluate the efficacy, safety, and pharmacokinetic characteristics of the intraocular port-type delivery system of ranibizumab in Chinese patients with neovascular age-related macular degeneration

本研究将在中国nAMD患者中评估与雷珠单抗0.5 mg Q4W玻璃体内注射相比，雷珠单抗100 mg/mL通过眼内港式给药系统植入Q24W给药的有效性、安全性和药代动力学特征。

[Translation]

This study will evaluate the efficacy, safety, and pharmacokinetic profile of ranibizumab 100 mg/mL administered Q24W via an intraocular port-type delivery system compared with ranibizumab 0.5 mg Q4W intravitreal injection in Chinese patients with nAMD.

Start Date02 Apr 2024

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+2]

NCT05126966 / WithdrawnPhase 3

A Phase IIIb, Multicenter, Randomized, Visual Assessor-Masked Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).

Start Date29 Dec 2023

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Ranibizumab (Genentech)

100 Translational Medicine associated with Ranibizumab (Genentech)

100 Patents (Medical) associated with Ranibizumab (Genentech)

4,967

Literatures (Medical) associated with Ranibizumab (Genentech)

01 Mar 2024·European journal of ophthalmology

Brolucizumab for recalcitrant macular neovascularization in age-related macular degeneration with pigment epithelial detachment

Article

Author: Ashurov, Agharza ; Schutz, James S ; Hattenbach, Lars-Olof ; Huynh, Elisa ; Jonas, Jost B ; Chronopoulos, Argyrios

Purpose:

To analyze anatomic and functional response to intravitreal brolucizumab in age-related macular degeneration recalcitrant to previous intravitreal anti-VEGF therapies.

Methods:

In this monocentric, one arm, retrospective study, eyes affected by neovascular age-related macular degeneration (nAMD) resistant to other intravitreally injected anti-vascular endothelial growth factor inhibitors were switched to intravitreal brolucizumab. All patients underwent ophthalmological examinations at baseline and in regular follow-up intervals. Best registered visual acuity (BRVA), Goldmann tonometry, intraocular pressure (IOP), central retinal thickness (CRT) and pigment epithelial detachment (PED) characteristics were analyzed at initiation of anti-VEGF treatment, at treatment switch, and at the end of brolucizumab loading phase.

Results:

The study included 20 eyes of 18 consecutively treated patients (age: 77 ± 6 years). All eyes had macular neovascularization with PED. Previous treatments included intravitreal aflibercept, bevacizumab, and ranibizumab and had not resulted in a significant improvement in BRVA (0.5 ± 0.5 logMAR vs 0.5 ± 0.6 logMAR) or mean CRT (320 ± 60 µm vs 313 ± 83 µm) up to treatment switch to brolucizumab. At the end of the brolucizumab loading phase, there was significant improvement for both BRVA (0.3 ± 0.2 logMAR, P < 0.05) and CRT (264 ± 55 µm, P < 0.05). Under previous anti-VEGF therapy, there was a significant increase/deterioration in both PED area (2.68 mm2 to 5.18 mm2, P < 0.05) and PED volume (0.39 mm3 to 1.07 mm3, P < 0.05); however, both parameters improved after switching to brolucizumab (3.81 mm2 and 0.37 mm3, P < 0.05).

Conclusion:

Our results suggest a favourable anatomical and visual response after treatment switch to brolucizumab in patients with nAMD refractory to previous anti-VEGF agents.

International journal of retina and vitreous

Comparison of antiangiogenic agents (ranibizumab, aflibercept, bevacizumab and ziv-aflibercept) in the therapeutic response to the exudative form of age-related macular degeneration according to the treat-and-extend protocol- true head-to-head study

Article

Author: Kanadani, Tereza ; Rabelo, Neiffer ; Farah, Michel ; Takahashi, Denise ; Magalhães, Lucas

Abstract:

Purpose:

To evaluate the structural and functional changes in eyes with neovascular age related macular degeneration (nAMD) in a real-world setting, using Treat and Extend protocol (T&E), comparing four antiangiogenic agents.

Methods:

Prospective, observational, case series study performed in 131 patients with the exudative form of nAMD. Patients were randomly assigned into four groups according to the antiangiogenic agent. During the first year, all eyes received at least 3 monthly intravitreal injections of antiangiogenic agents, and afterwards, were submitted to the T&E.

Results:

There was statistically significant difference (p < 0.05) between pre- and post-treatment in the best corrected visual acuity measurements by drug used. Patients who used aflibercept had significantly fewer injections than patients using the other drugs (mean = 9.03). No significant difference was observed between the drugs bevacizumab, ranibizumab and ziv-aflibercept. With regard to biomarkers, patients who used aflibercept and had lower baseline central retinal thickness, absence of hyperreflective foci and no subretinal hyperreflective material had the lowest number of injections.

Conclusion:

Results indicate that over 2 years, Intravitreal aflibercept on T&E provided better visual and anatomical improvements when compared to other drugs used in this study with significantly fewer injections.

01 Feb 2024·Journal of controlled release : official journal of the Controlled Release Society

Stability of ranibizumab during continuous delivery from the Port Delivery Platform

Article

Author: Tam, Tammy ; Zheng, Kai ; Horvath, Judit ; de Jong, Isabella ; Chang, Debby P ; Yohe, Stefan T ; Rea, Jennifer ; Ranade, Shrirang V ; Hieb, Aaron R

The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system that has the potential to reduce treatment burden in patients with retinovascular diseases. The Port Delivery Platform (PD-P) implant is a permanent, indwelling device that can be refilled in situ through a self-sealing septum and is designed to continuously deliver ranibizumab by passive diffusion through a porous titanium release control element. We present results for the studies carried out to characterize the stability of ranibizumab for use with the PD-P. Simulated administration, in vitro release studies, and modeling studies were performed to evaluate the compatibility of ranibizumab with the PD-P administration components, and degradation and photostability in the implant. Simulated administration studies demonstrated that ranibizumab was highly compatible with the PD-P administration components (initial fill and refill needles) and commercially available administration components (syringe, transfer needle, syringe closure). Subsequent simulated in vitro release studies examining continuous delivery for up to 12 months in phosphate buffered saline, a surrogate for human vitreous, showed that the primary degradation products of ranibizumab were acidic variants. The presence of these variants increased over time and potency remained high. The stability attributes of ranibizumab were consistent across multiple implant refill-exchanges. Despite some degradation within the implant, the absolute mass of variants released daily from the implant was low due to the continuous release mechanism of the implant. Simulated light exposure within the implant resulted in small increases in the relative amount of ranibizumab degradants compared with those seen over 6 months.

291

News (Medical) associated with Ranibizumab (Genentech)

01 Jul 2024

·www.globenewswire.com

Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO)

Positive recommendation is based on two Phase III studies. In addition to robust retinal drying with Vabysmo, these data show early and sustained vision improvements, which are non-inferior to aflibercept If approved, Vabysmo would be the first and only bispecific antibody treatment available for the nearly one million people with RVO in the European Union Vabysmo is already approved in the US and Japan for RVO and in more than 95 countries around the world for people living with nAMD and DME 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo® (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision regarding the approval is expected from the European Commission in the near future. “This CHMP recommendation represents an important step towards bringing Vabysmo to even more patients living with vision loss in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Recognising the disruptive impact retinal vein occlusion can have on the everyday lives and independence of these patients, we hope that Vabysmo will offer a new treatment option that can effectively help preserve and improve their vision.” The CHMP decision is based on full 72-week data from the Phase III BALATON and COMINO studies evaluating Vabysmo in more than 1,200 people with macular edema due to branch and central RVO (BRVO and CRVO).1,2 In both studies, Vabysmo demonstrated early and sustained vision improvements non-inferior to aflibercept, and robust retinal drying. Vabysmo was well tolerated and the safety profile was consistent with previous studies.3 Current available treatments for RVO are typically given every one to two months. 4,5 Vabysmo was first approved for RVO by the United States Food and Drug Administration in October 2023 and by the Japan Ministry of Health, Labour and Welfare in March 2024.6-8 It is also approved in more than 95 countries around the world for people living with neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).6,8-11 Roche has the broadest retina pipeline in ophthalmology. Led by science and informed by insights from people with eye conditions, Roche is committed to saving people’s eyesight from the leading causes of vision loss through pioneering treatments. RVO is the second most common cause of vision loss due to retinal vascular diseases. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss.12,13 The level of angiopoietin-2 (Ang-2) is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.14,15 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema.13,16,17 Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.16 There are two main types of RVO: branch RVO, which affects more than 23 million people globally and occurs when one of the four smaller ‘branches’ of the main central retinal vein becomes blocked; and central RVO, which is less common, affecting more than four million people worldwide, and occurs when the eye’s central retinal vein becomes blocked.12,17 BALATON (NCT04740905) and COMINO (NCT04740931) were two randomised, multicentre, global Phase III studies evaluating the efficacy and safety of Vabysmo®️ (faricimab) compared to aflibercept. For the first 20 weeks, patients were randomised 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients received Vabysmo (6.0 mg) up to every four months using a treat-and-extend dosing regimen. The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints included change in central subfield thickness and drying of retinal fluid from baseline over time up to week 24. Roche has a robust Phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X (NCT04777201), an extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD), and RHONE-X (NCT04432831), an extension study of YOSEMITE (NCT03622580) and RHINE (NCT03622593) evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME).18,19 Roche has also initiated several Phase IV studies, including the ELEVATUM (NCT05224102) study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of nAMD highly prevalent in Asia, and the POYANG (NCT06176352) study of Vabysmo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia.20-22 Roche has also initiated the VOYAGER (NCT05476926) study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.23 Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.24 Vabysmo is approved in more than 95 countries around the world, including the United States, Japan, the United Kingdom and the European Union for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema and in several countries, including the US and Japan, for RVO.4,6-9 Review by other regulatory authorities is ongoing. Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments across multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the U.S. Food and Drug Administration in 2021.25 Vabysmo is approved around the world for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US and Japan for macular edema following retinal vein occlusion. 4,6-9 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.5 Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. References [1] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (RVO) (BALATON) [Internet; cited June 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905. [2] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited June 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931. [3] Ghanchi, et al. Efficacy, safety, and durability of faricimab in macular edema due to RVO: 72-week results from the Phase III BALATON and COMINO trials. Poster presented at: ARVO Annual Meeting, May, 5-9 2024, Seattle WA, US. Poster #A0388. [4] U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf. [5] FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf. [6] FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf. [7] FDA approves Genentech’s Vabysmo for the treatment of RVO [Internet; cited June 2024]. Available from: https://www.gene.com/media/press-releases/15009/2023-10-26/fda-approves-genentechs-vabysmo-for-the-treatment-of-RVO. [8] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited June 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. [9] European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited June 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf. [10] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) [Internet; cited January 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html. [11] Roche data on file. [12] Song P, et al. Global epidemiology of RVO: a systematic review and meta-analysis of prevalence, incidence and risk factors. J Glob Health. 2019;9:010427. [13] Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited June 2024]. Available from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion. [14] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021;35:1305-1316. [15] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016;8:1265–88. [16] Schmidt-Erfurth U, et al. Guidelines for the management of retinal vein occlusion by the European society of retina specialists (EURETINA). Ophthalmologica. 2019;242:123-162. [17] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015;49:67-81. [18] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with nAMD (AVONELLE-X) [Internet; cited June 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04777201. [19] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with DME (RHONE-X) [Internet; cited June 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831. [20] Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with DME (ELEVATUM). [Internet; cited June 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT05224102. [21] APVRS. Design and rationale of the SALWEEN Trial: A Phase IIIb/IV Study of faricimab, a dual angiopoietin-2 and vascular endothelial growth factor-a inhibitor, in patients with polypoidal choroidal vasculopathy. [Internet; cited June 2024]. Available from: https://2022.apvrs.org/abstract/?code=200351. [22] A study to evaluate the efficacy and safety of faricimab in patients with choroidal neovascularisation secondary to pathologic myopia (POYANG). [Internet; cited June 2024]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT06176352. [23] Clinical Trials.gov. A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER). [Internet; cited January 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT05476926. [24] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, Phase III, non-inferiority trials. The Lancet. 2022;399:729-740. [25] FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical Result

19 Jun 2024

·www.globenewswire.com

Opthea A$55.0m (US$36.9m¹) Retail Entitlement Offer Opens

Fully underwritten Retail Entitlement Offer to open at 9:00 am (Melbourne time) on 19 June 2024 Retail Entitlement Offer to raise approximately A$55.0m (US$36.9m1) will close at 5:00 pm (Melbourne time) on 10 July 2024 Prospectus and personalized application forms to be dispatched to eligible retail shareholders MELBOURNE, Australia, and PRINCETON N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that the retail component of its 1 for 1.22 pro-rata accelerated non-renounceable entitlement offer (Retail Entitlement Offer) of new fully paid ordinary shares in Opthea (New Shares) and the issue of options to acquire fully paid ordinary shares in Opthea (Options) on a 1 for 3 basis to participants issued New Shares under the Retail Entitlement Offer opens today. The Retail Entitlement Offer is fully underwritten. This Retail Entitlement Offer follows a successful Institutional Entitlement Offer and institutional Placement raising approximately A$171.5m (US$113.2m1). Opthea advises that it will today complete dispatch of the following documents to Eligible Retail Shareholders (as defined in Opthea’s Prospectus, which was lodged with ASIC on Wednesday, 12 June 2024 (Prospectus)): to Eligible Retail Shareholders who nominated to receive documents from Opthea by electronic means, personalized details of the Retail Entitlement Offer by such electronic means; andto any other Eligible Retail Shareholder, a letter notifying them of the Retail Entitlement Offer and providing instructions on how to participate in the Retail Entitlement Offer, including in each case, details of how to access the Prospectus. The Prospectus contains information about the Entitlement Offer of New Shares and the issue of Options on a 1 for 3 basis to participants issued New Shares under the Retail Entitlement Offer and Opthea's preceding Institutional Entitlement Offer and institutional Placement, details of which were announced to ASX on Wednesday, 12 June 2024. As announced on Wednesday, 12 June 2024, the proceeds from the capital raising are intended to be used by Opthea to continue advancing the clinical development of sozinibercept for the treatment of wet AMD. This includes funding the Company, together with cash on hand through the anticipated Phase 3 topline data readouts for COAST (Combination OPT-302 with Aflibercept Study), and ShORe (Study of OPT-302 in combination with Ranibizumab), which were designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies compared to standard of care alone. The funds are also intended to progress the chemistry, manufacturing, and controls (CMC) activities, Biologics License Application (BLA) preparations for FDA approval and for general corporate purposes. A copy of the Prospectus is available to Eligible Retail Shareholders at www.computersharecas.com.au/opt2024offer and a letter to retail shareholders who are ineligible to participate in the Retail Entitlement Offer notifying them of their ineligibility to participate has also been dispatched (an example of which is attached). Fully Underwritten Retail Entitlement Offer The Retail Entitlement Offer opens on Wednesday, 19 June 2024 and is expected to close at 5:00pm (AEST, Melbourne time) on Wednesday, 10 July 2024. Eligible Retail Shareholders may opt to take up all, part or none of their entitlement. Eligible Retail Shareholders will also have the opportunity to apply for and be allocated additional New Shares up to 25% of their entitlement (subject to scale back at the sole discretion of Opthea) (Top-Up Facility). Only Eligible Retail Shareholders (as defined in the Prospectus) are entitled to participate in the Retail Entitlement Offer. Opthea may (in its absolute discretion) extend the Retail Entitlement Offer to any institutional shareholder that was eligible to, but was not invited to participate in, the Institutional Entitlement Offer (subject to compliance with relevant laws). The Retail Entitlement Offer is fully underwritten. The underwriting is subject to the terms and conditions of the Underwriting Agreement, which are summarized in the Investor Presentation and Prospectus. The Retail Entitlement Offer will raise an additional approximately A$55.0 million (US$36.9m1). Application monies must be received prior to the end of the offer period in accordance with the Prospectus. New Options Participants in the Retail Entitlement Offer will receive 1 option, each exercisable at A$1.00 per option and expiring on 30 June 2026 (New Options), for every 3 New Shares issued under Retail Entitlement Offer. The offer of New Options is made under the Prospectus. No additional consideration is payable in respect of the New Options. All New Options are expected to be issued upon allotment of the Retail Entitlement Offer and, subject to satisfying spread requirements set out in ASX Listing Rule 2.5, condition 6, the options are intended to be quoted on the ASX. The full terms and conditions of the New Options are set out in the Prospectus. Copies of the Prospectus are available on the ASX website and at www.opthea.com. Timetable The timetable below is indicative only and subject to change. The Company reserves the right to alter the dates below in its full discretion and without prior notice, subject to the ASX Listing Rules and the Corporations Act. ItemDateTrading Halt and announcement of the Capital Raising, lodgment of Offer Documents, including Prospectus with ASICWednesday, 12 June 2024Placement and Institutional Entitlement Offer opensWednesday, 12 June 2024Placement and Institutional Entitlement Offer closesThursday, 13 June 2024Announcement of completion of the Institutional Entitlement Offer and Placement, trading halt lifted, existing securities recommence tradingFriday, 14 June 2024Record Date for Entitlement Offer7:00pm (Melbourne time) on Friday, 14 June 2024Despatch of Prospectus under Retail Entitlement OfferWednesday, 19 June 2024Retail Entitlement Offer opens9:00am (Melbourne time) on Wednesday, 19 June 2024Settlement of New Shares issued under the Institutional Entitlement Offer and PlacementThursday, 20 June 2024Allotment of New Shares issued under the Institutional Entitlement Offer and PlacementFriday, 21 June 2024Retail Entitlement Offer closes5:00pm (Melbourne time) on Wednesday, 10 July 2024Announcement of results of the Retail Entitlement Offer and notification of any shortfall under the Retail Entitlement OfferMonday, 15 July 2024Settlement of New Shares under the Retail Entitlement Offer and any shortfall under the Retail Entitlement OfferTuesday, 16 July 2024Allotment and issue of New Shares and New Options under the Retail Entitlement Offer, and New Options issued under the Institutional Entitlement Offer and PlacementWednesday, 17 July 2024Trading commences on a normal basis for New Shares issued under the Retail Entitlement Offer and New Options under the Entitlement Offer and PlacementThursday, 18 July 2024Despatch of holding statements for New Shares issued under the Retail Entitlement Offer and New Options under the Entitlement Offer and PlacementFriday, 19 July 2024 About Opthea Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age- related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents. To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn. Inherent Risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-Looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding rapidly advancing the registrational program for sozinibercept in wet AMD, expectations regarding the pivotal growth phase of Opthea, the ability of sozinibercept to enhance vision outcomes for patients worldwide, Opthea’s expected cash runway, the expected timing for topline data readout, and the expected use of proceeds. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, Opthea’s ability to continue as a going concern, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, clinical research organization, contract manufacturer; Biologics License Application preparation, corporate and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023, Opthea’s 2024 Half Year Report included as an exhibit to the Form 6-K filed with the SEC on February 29, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Not An Offer This ASX announcement is not a disclosure document and should not be considered as investment advice. The information contained in this ASX announcement is for information purposes only and should not be considered an offer or an invitation to acquire Company securities or any other financial products and does not and will not form part of any contract for the acquisition of New Shares. In particular, this ASX announcement does not constitute an offer to sell, or a solicitation of any offer to buy, any securities in the United States or any other jurisdiction in which such an offer would be illegal or impermissible. The securities to be offered and sold in the Placement and Entitlement Offer have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or the securities laws of any state or other jurisdiction of the United States. No public offering of securities is being made in the United States. Accordingly, the securities to be offered and sold in the Placement and Entitlement Offer may only be offered and sold outside the United States in “offshore transactions” (as defined in Rule 902(h) under Regulation S of the U.S. Securities Act (“Regulation S”)) in reliance on Regulation S, unless they are offered and sold in a transaction registered under, or exempt from, or in a transaction not subject to, the registration requirements of, the U.S. Securities Act and applicable U.S. state securities laws. Authorized for release to ASX by Opthea’s Company Secretary Investor & Media Inquiries PJ KelleherLifeSci Advisors, LLCEmail: pkelleher@lifesciadvisors.comPhone: 617-430-7579 Join our email database to receive program updates:Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com Source: Opthea Limited 1. Assumes AUD/USD exchange rate of A$1.00/US$0.66

Phase 3

13 Jun 2024

·www.globenewswire.com

Opthea Successfully Completes Placement and Institutional Component of Entitlement Offer Raising A$171.5 million (US$113.2m¹)

Fully underwritten Retail Entitlement Offer to raise a further approximately A$55.9m (US$36.9m1) will open on 19 June 2024 and close at 5:00 pm (Melbourne time) on 10 July 2024 MELBOURNE, Australia and PRINCETON, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the successful completion of the institutional component of the capital raising announced on Wednesday, 12 June 2024. The non-underwritten institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of the partially underwritten 1 for 1.22 pro-rata accelerated non-renounceable entitlement offer (Entitlement Offer) together raised approximately A$171.5 million (US$113.2m1). The Institutional Entitlement Offer alone raised approximately A$161.5 million. Eligible institutional shareholders took up approximately 61.4% of their entitlements with the shortfall placed to both new and existing institutional shareholders and to the underwriter. Approximately 428.7 million shares will be issued under the Placement and the Institutional Entitlement Offer (New Shares) at an offer price of A$0.40 per New Share. Of this, the underwriter will be issued approximately 55.4 million shares under the Institutional Entitlement Offer in accordance with the arrangements described in the Prospectus. New Shares to be issued under the Placement and the Institutional Entitlement Offer will rank equally with existing OPT shares in all respects from the date of issue. Settlement of New Shares issued under the Placement and Institutional Entitlement Offer is expected to occur on Thursday, 20 June 2024. The issue of those New Shares is expected to occur on Friday, 21 June 2024, with ordinary trading commencing on the same day. “We appreciate the strong support from our shareholders, and from new investors, who share our belief that sozinibercept has the potential to transform patient outcomes with superior vision gains, which continues to be a significant unmet need in wet AMD,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “This financing extends Opthea’s cash runway through the anticipated Phase 3 topline data readout of the COAST and ShORe pivotal trials of sozinibercept in wet AMD which are now expected in the early second quarter of calendar year 2025 and in mid-calendar year 2025, respectively. We look forward to updating you as we progress.” As announced on Wednesday, 12 June 2024, the proceeds from the capital raising, together with cash on hand, will be used to fund the Company through the anticipated Phase 3 topline data readouts for COAST (Combination OPT-302 with Aflibercept Study), and ShORe (Study of OPT-302 in combination with Ranibizumab), which were designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies compared to standard of care alone. The funds are also intended to be used to progress chemistry, manufacturing, and controls (CMC) activities, Biologics License Application (BLA) preparations for FDA approval, and for general corporate purposes. Retail Entitlement Offer Eligible shareholders who have a registered address in Australia or New Zealand on the register as at 7:00 pm (Melbourne time) on the Friday, 14 June 2024 Record Date and who were not invited to participate in the Institutional Entitlement Offer will be invited to participate in the retail component of the Entitlement Offer (Retail Entitlement Offer) at the same Offer Price and offer ratio as under the Institutional Entitlement Offer. The Retail Entitlement Offer is expected to open on Wednesday, 19 June 2024, and close at 5:00pm (Melbourne time) on Wednesday, 10 July 2024. The Retail Entitlement Offer will be made under the Prospectus. The Prospectus was lodged with ASIC and released on ASX on Wednesday, 12 June 2024 and will be dispatched to eligible retail shareholders, along with personalized application forms on Wednesday, 19 June 2024. The Prospectus provides details of how to participate in the Retail Entitlement Offer. Eligible retail shareholders may opt to take up all, part or none of their entitlement. Eligible retail shareholders will also have the opportunity to apply for and be allocated additional New Shares up to 25% of their entitlement (subject to scale back at the sole discretion of Opthea) (Top-Up Facility). Opthea may (in its absolute discretion) extend the Retail Entitlement Offer to any institutional shareholder that was eligible to, but was not invited to participate in, the Institutional Entitlement Offer (subject to compliance with relevant laws). The Retail Entitlement Offer is fully underwritten. The underwriting is subject to the terms and conditions of the Underwriting Agreement, which are summarized in the Investor Presentation and Prospectus. The Retail Entitlement is additionally to raise approximately A$55.9 million (US$36.9m1). New Options Participants in the Placement and Entitlement Offer will also be offered one (1) option, each exercisable at A$1.00 per option and expiring on 30 June 2026 (New Options), for every three (3) New Shares subscribed under the Placement and Entitlement Offer. The offer of New Options is made under the Prospectus. No additional consideration is payable in respect of the New Options. All New Options are expected to be issued upon allotment of the New Shares under the Retail Entitlement Offer and, subject to satisfying spread requirements set out in ASX Listing Rule 2.5, condition 6, the Options are intended to be quoted on the ASX. The full terms and conditions of the New Options are set out in the Prospectus. Copies of the Prospectus will be available on the ASX website and at www.opthea.com. Timetable The timetable below is indicative only and subject to change. The Company reserves the right to alter the dates below in its full discretion and without prior notice, subject to the ASX Listing Rules and the Corporations Act. ItemDateTrading Halt and announcement of the Capital Raising, lodgment of Offer Documents, including Prospectus with ASICWednesday, 12 June 2024Placement and Institutional Entitlement Offer opensWednesday, 12 June 2024Placement and Institutional Entitlement Offer closesThursday, 13 June 2024Announcement of completion of the Institutional Entitlement Offer and Placement, trading halt lifted, existing securities recommence tradingFriday, 14 June 2024Record Date for Entitlement Offer7:00pm (Melbourne time) on Friday, 14 June 2024Despatch of Prospectus under Retail Entitlement OfferWednesday, 19 June 2024Retail Entitlement Offer opensWednesday, 19 June 2024Settlement of New Shares issued under the Institutional Entitlement Offer and PlacementThursday, 20 June 2024Allotment of New Shares issued under the Institutional Entitlement Offer and PlacementFriday, 21 June 2024Retail Entitlement Offer closes5:00pm (Melbourne time) on Wednesday, 10 July 2024Announcement of results of the Retail Entitlement Offer and notification of any shortfall under the Retail Entitlement OfferMonday, 15 July 2024Settlement of New Shares under the Retail Entitlement Offer and any shortfall under the Retail Entitlement OfferTuesday, 16 July 2024Allotment and issue of New Shares and New Options under the Retail Entitlement Offer, and New Options issued under the Institutional Entitlement Offer and PlacementWednesday, 17 July 2024Trading commences on a normal basis for New Shares issued under the Retail Entitlement Offer and New Options under the Entitlement Offer and PlacementThursday, 18 July 2024Despatch of holding statements for New Shares issued under the Retail Entitlement Offer and New Options under the Entitlement Offer and PlacementFriday, 19 July 2024 About Opthea Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate, sozinibercept, is being evaluated in two pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents. To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn. Inherent Risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-Looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding rapidly advancing the registrational program for sozinibercept in wet AMD, expectations regarding the pivotal growth phase of Opthea, the ability of sozinibercept to enhance vision outcomes for patients worldwide, Opthea’s expected cash runway, the expected timing for topline data readout, and the expected use of proceeds. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the completion of the capital raising, Opthea’s ability to continue as a going concern, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, clinical research organization, contract manufacturer; Biologics License Application preparation, corporate and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023, Opthea’s 2024 Half Year Report included as an exhibit to the Form 6-K filed with the SEC on February 29, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Not An Offer This ASX announcement is not a disclosure document and should not be considered as investment advice. The information contained in this ASX announcement is for information purposes only and should not be considered an offer or an invitation to acquire Company securities or any other financial products and does not and will not form part of any contract for the acquisition of New Shares. In particular, this ASX announcement does not constitute an offer to sell, or a solicitation of any offer to buy, any securities in the United States or any other jurisdiction in which such an offer would be illegal or impermissible. The securities to be offered and sold in the Placement and Entitlement Offer have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or the securities laws of any state or other jurisdiction of the United States. No public offering of securities is being made in the United States. Accordingly, the securities to be offered and sold in the Placement and Entitlement Offer may only be offered and sold outside the United States in “offshore transactions” (as defined in Rule 902(h) under Regulation S of the U.S. Securities Act (“Regulation S”)) in reliance on Regulation S, unless they are offered and sold in a transaction registered under, or exempt from, or in a transaction not subject to, the registration requirements of, the U.S. Securities Act and applicable U.S. state securities laws. Authorized for release to ASX by Frederic Guerard, CEO Investor & Media Inquiries PJ Kelleher LifeSci Advisors, LLC Email: pkelleher@lifesciadvisors.com Phone: 617-430-7579 Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com Source: Opthea Limited Assumes AUD/USD exchange rate of A$1.00/US$0.66

Phase 3

100 Deals associated with Ranibizumab (Genentech)

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KEGG	Wiki	ATC	Drug Bank
D05697	Ranibizumab (Genentech)	S01LA04	DB01270

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Retinopathy of Prematurity	JP	Novartis Pharma KK	22 Nov 2019
Diabetic Retinopathy	US	Genentech, Inc.	06 Feb 2015
Age Related Macular Degeneration	JP	Novartis Pharma AG	21 Jan 2009
Choroidal Neovascularization	EU	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	IS	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	LI	Novartis Europharm Ltd.	22 Jan 2007
Choroidal Neovascularization	NO	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	EU	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	IS	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	LI	Novartis Europharm Ltd.	22 Jan 2007
Diabetic macular oedema	NO	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	EU	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	IS	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	LI	Novartis Europharm Ltd.	22 Jan 2007
Macular Edema	NO	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	EU	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	IS	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	LI	Novartis Europharm Ltd.	22 Jan 2007
Retinal Vein Occlusion	NO	Novartis Europharm Ltd.	22 Jan 2007
Vision Disorders	EU	Novartis Europharm Ltd.	22 Jan 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myopia	Phase 3	CN	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	HK	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	IN	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	PH	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	KR	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopia	Phase 3	TH	Novartis Pharmaceuticals Corp.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Beijing Novartis Pharma Co. Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Novartis Europharm Ltd.	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	CN	Novartis Pharma Stein AG	11 Sep 2013
Myopic choroidal neovascularization	Phase 3	IN	Novartis Europharm Ltd.	11 Sep 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02640664 (RAINBOW, Pubmed)	Phase 3	Retinopathy of Prematurity vascular endothelial growth factor (VEGF)	201	Intravitreal ranibizumab 0.2 mg	gvkhksvncc(swnmfswmrr) = mnzilgsskr bgzskhlfum (cnosyasftq, 62.9 - 70.7)	Positive	01 May 2024
				Intravitreal ranibizumab 0.1 mg	gvkhksvncc(swnmfswmrr) = qywsrfujuc bgzskhlfum (cnosyasftq, 60.6 - 68.5)
ARVO2023	Not Applicable	Retinopathy of Prematurity First line	44	Intravitreal ranibizumab 0.2 mg	rviqruprty(cubdridjxd) = vkengbukkh xzudnamixp (bebvelyuvm ) View more	-	01 Jun 2023
ARVO2023	Not Applicable	Diabetic macular oedema	-	Ranibizumab	taqyinvezd(bvzcynlvrx) = mzoxbrchlj gffivmabjx (bqdfytximf )	-	23 Apr 2023
				Ranibizumab	taqyinvezd(bvzcynlvrx) = dshtwfjypx gffivmabjx (bqdfytximf )
ARVO2023	Not Applicable	Choroidal Neovascularization	220	ranibizumab	pwyorcgddx(gfmuihflxd) = yycvczecwz xmxsoqrkim (eqoipqfgak ) View more	Positive	23 Apr 2023
				ranibizumab	yijsunbjck(viatrxybno) = ritzsbtaet dallhizyhs (klmsjunpyy )
ARVO2023	Phase 3	Retinal Vein Occlusion	24	Intravitreal ranibizumab (IVR) with SRT	gadocoghqk(gnotchtfju) = uaabujlcsw qdfzjlpftw (mnlmcmhujh ) View more	Positive	23 Apr 2023
				Intravitreal ranibizumab (IVR) with sham SRT	gadocoghqk(gnotchtfju) = utkdfpizpg qdfzjlpftw (mnlmcmhujh ) View more
RAINBOW Trial (ARVO2023)	Not Applicable	Retinopathy of Prematurity	180	Ranibizumab 0.2mg	slbieiqqoh(iqmegxuozw) = uypdtulzpo lfngzjwyss (lyixkxspfj, -1.1 to 10.5) View more	-	23 Apr 2023
				Ranibizumab 0.1mg	slbieiqqoh(iqmegxuozw) = nwjjywihql lfngzjwyss (lyixkxspfj, -3.4 to 8.3) View more
NCT00056836 (MARINA Study, Pubmed)	Phase 3	Age Related Macular Degeneration	-	Ranibizumab 0.3 mg	xhxvtxfauz(kzkusahwed) = qynvrsjxbe bcprvfwzse (rqnahpbiju )	-	22 Apr 2023
				Ranibizumab 0.5 mg	xhxvtxfauz(kzkusahwed) = befhhqdcqz bcprvfwzse (rqnahpbiju )
Pubmed	Phase 3	Diabetic macular oedema \| Diabetic Retinopathy	777	Ranibizumab	cpzzrqogkt(qefjdgipjk) = skjpwcyorn oknekockkf (ktzislndtq, 5.6 - 6.4)	-	10 Feb 2023
NCT00891735 (HARBOR, Pubmed)	Phase 3	Age Related Macular Degeneration	222	As-needed ranibizumab therapy	rrevmiyeil(rtwaxtfbdc) = iicqnomqdr uaapybqgan (liltdtqnjj, 0.4, 4.0)	-	20 Dec 2022
NCT01469156 (CTgov)	Phase 1/2	Polypoidal choroidal vasculopathy	20	ranibizumab 0.5 or 2.0 mg/0.05 cc	uryrcetjla(wqrygcyddt) = nftuetoaln vjmqhhrahq (syjnkxnalm, tfkbrudpjc - mikzizyjgq) View more	-	12 Dec 2022

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