The study on efficacy and safety of Ensatinib combined with Vorolanib in the treatment of advanced non-small cell lung cancer with ALK positivity and high PD-L1 expression

Start Date01 Jan 2025

Sponsor / Collaborator

West China Hospital

NCT06730672 / Not yet recruitingPhase 2IIT

Efficacy and Safety of Voronib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma

This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Voronib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.

Start Date10 Dec 2024

Sponsor / Collaborator

Sun Yat-Sen University

NCT06728852 / RecruitingPhase 2IIT

Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study

This study evaluates the efficacy and safety of Vorolanib as monotherapy for advanced non-small cell lung cancer (NSCLC) patients receiving third-line or higher treatments. It is a single-center, single-arm, prospective Phase II clinical trial. Thirty-two patients who have undergone at least two lines of systemic therapy and exhibited progression or recurrence will receive 300 mg of Vorolanib daily until disease progression, intolerable toxicity, withdrawal of consent, or death. The primary endpoint is the 6-month progression-free survival (PFS) rate. Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. This research aims to expand the clinical applications of Vorolanib in NSCLC, providing a basis for further investigation.

Start Date01 Dec 2024

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Vorolanib

100 Translational Medicine associated with Vorolanib

100 Patents (Medical) associated with Vorolanib

Literatures (Medical) associated with Vorolanib

01 Nov 2024·Therapeutic Delivery

Role of EYP-1901 in neovascular age-related macular degeneration and diabetic eye diseases: review of Phase I/II trials

Review

Author: Canizela, Cecilia ; Hussain, Rehan M ; Sayed, Abrahem ; Ravichandran, Pranesh

EYP-1901 (Duravyu) has demonstrated promising outcomes in Phases I and II clinical trials for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)/diabetic retinopathy. This innovative treatment capitalizes on the potent anti-angiogenic properties of vorolanib, an inhibitor that targets all isoforms of VEGF, effectively mitigating the pathological neovascularization and vascular permeability that underpin these retinal conditions. EYP-1901 is integrated with the Durasert drug delivery system to administer a sustained release of vorolanib directly to the posterior segment of the eye. This delivery system ensures a consistent therapeutic effect over an extended period and significantly reduces the frequency of clinical interventions required, offering a more convenient treatment regimen while maintaining patient safety.

01 Sep 2024·Ophthalmology science

Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration

Article

Author: Lally, David R ; Eichenbaum, David A ; Bakri, Sophie J ; Roy, Monica ; Hershberger, Vrinda ; Bridges, William Z ; Boyer, David S ; Paggiarino, Dario A ; Patel, Sunil ; Storey, Philip P ; Barakat, Mark R

Purpose:

To evaluate safety and tolerability of EYP-1901, an intravitreal insert containing vorolanib, a pan-VEGF receptor inhibitor packaged in a bioerodible delivery technology (Durasert E™) for sustained delivery, in patients with wet age-related macular degeneration (wAMD) previously treated with anti-VEGF therapy.

Design:

Phase I, multicenter, prospective, open-label, dose-escalation trial.

Participants:

Patients with wAMD and evidence of prior anti-VEGF therapy response.

Methods:

Patients received a single intravitreal injection of EYP-1901.

Main Outcome Measures:

The primary objective was to evaluate safety and tolerability of EYP-1901. Secondary objectives assessed biologic activity of EYP-1901 including best-corrected visual acuity (BCVA) and central subfield thickness (CST). Exploratory analyses included reduction in anti-VEGF treatment burden and supplemental injection-free rates.

Results:

Seventeen patients enrolled in the 440 μg (3 patients), 1030 μg (1 patient), 2060 μg (8 patients), and 3090 μg (5 patients) dose cohorts. No dose-limiting toxicity, ocular serious adverse events (AEs), or systemic AEs related to EYP-1901 were observed. There was no evidence of ocular or systemic toxicity related to vorolanib or the delivery technology. Moderate ocular treatment-emergent AEs (TEAEs) included reduced visual acuity (2/17) and retinal exudates (3/17). One patient with reduced BCVA had 3 separate reductions of 17, 18, and 16 letters, and another had a single drop of 25 letters. One severe TEAE, neovascular AMD (i.e., worsening/progressive disease activity), was reported in 1 of 17 study eyes but deemed unrelated to treatment. Mean change from baseline in BCVA was -1.8 letters and -5.4 letters at 6 and 12 months. Mean change from baseline in CST was +1.7 μm and +2.4 μm at 6 and 12 months. Reduction in treatment burden was 74% and 71% at 6 and 12 months. Of 16 study eyes, 13, 8, and 5 were injection-free up to 3, 6, and 12 months.

Conclusion:

In the DAVIO trial (ClinicalTrials.gov identifier, NCT04747197), EYP-1901 had a favorable safety profile and was well tolerated in previously treated eyes with wAMD. Measures of biologic activity remained relatively stable following a single EYP-1901 injection. These preliminary data support ongoing phase II and planned phase III trials to assess efficacy and safety.

Financial Disclosures:

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

01 Mar 2024·Bioorganic chemistry

Potential oral VEGFR2 inhibitors: Treatment of wet age-related macular degeneration

Article

Author: Liu, Yaoyang ; Cheng, Maosheng ; Yang, Huali ; Liu, Yang ; Zhao, Xueqi ; Hu, Dexiang ; Xiu, Xiaomeng ; Li, Zhenli ; Wang, Hanxun ; Jia, Hongwei ; Li, Mengzhen

Wet age-related macular degeneration (w-AMD) is one of the leading causes of vision loss in industrialized countries. A large body of evidence suggests that inhibitors targeting VEGFR2 may be effective in the treatment of w-AMD. The identification of an oral VEGFR2 inhibitor for the treatment of w-AMD provides an opportunity for a route of administration other than intravitreal injection. While screening potent VEGFR2 inhibitors at the enzyme and cellular levels, ensuring the safety of the compounds was our primary strategy for screening optimal compounds. Finally, compound 16 was identified, exhibiting enhanced inhibition of VEGFR2 enzyme and proliferation of BaF3-TEL-VEGFR2 cells compared to Vorolanib. Compound 16 had a weak inhibitory effect on human Ether-a-go-go-related gene (hERG) channel currents, showing a cardiac safety profile similar to Vorolanib. Compound 16 showed no significant toxicity to human liver cell LX-2, indicating a liver safety profile similar to Vorolanib. The water solubility of compound 16 was found to be higher than that of Vorolanib when tested at pH = 7.4. In addition, compound 16 was found to inhibit VEGFR2 phosphorylation in human umbilical vein endothelial cells (HUVECs) in a dose-dependent manner by WB assay. Furthermore, the in vitro preliminary evaluation of the drug-like properties of compound 16 showed remarkable plasma stability and moderate liver microsomal stability. Based on in vivo pharmacokinetic studies in ICR mice, compound 16 exhibited acceptable oral bioavailability (F = 20.2 %). Overall, these findings provide evidence that compound 16 is a leading potential oral drug candidate for w-AMD.

135

News (Medical) associated with Vorolanib

04 Dec 2024

·www.globenewswire.com

EyePoint Announces First Patient Dosed in Second Global Phase 3 LUCIA Clinical Trial of DURAVYU™ for the Treatment of Wet Age-Related Macular Degeneration

– Topline data for Phase 3 pivotal program anticipated in 2026 – WATERTOWN, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the LUCIA trial, the Company’s second global Phase 3 clinical trial of DURAVYU, formerly EYP-1901, for the treatment of wet age-related macular degeneration (wet AMD). DURAVYU is an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E™ for sustained intraocular delivery. “Dosing the first patient in our second global Phase 3 clinical trial, the LUCIA trial, marks another significant milestone demonstrating our continued focus on execution at EyePoint,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “We are encouraged by the robust physician and patient interest in DURAVYU with enrollment in our first pivotal trial, the LUGANO trial, exceeding our expectations. With two simultaneous Phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for wet AMD, and a strong balance sheet, we are well-positioned as the leader in sustained-release ocular drug delivery bringing impactful therapies to patients suffering from serious retinal diseases.” “We are pleased to have dosed the first patient in the LUCIA trial so soon after dosing the first patient in the LUGANO trial. This underscores our commitment to develop innovative therapies with the potential to change the current treatment paradigm in wet AMD,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “The Phase 3 pivotal program is the first and only sustained release wet AMD pivotal program evaluating re-dosing in both trials. Following a typical non-inferiority approval pathway, the LUGANO and LUCIA trials will provide data on the efficacy, durability, safety and dosing flexibility of treatment with DURAVYU and have the potential to provide the retina community valuable insights on how DURAVYU could be used in ‘real-world’ practice. With over 240 global sites already committed across both Phase 3 trials and exceptional patient and investigator enthusiasm, we are confident we can rapidly enroll patients in the Phase 3 pivotal trials.” “Patients with wet AMD typically require life-long treatment with frequent intravitreal injections to preserve their vision. This high treatment burden often results in under-treatment and irreversible vision loss,” said Adam Gerstenblith, M.D., principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists. “The Phase 3 LUCIA trial is an important step forward in our pursuit of more durable treatments that are safe and effective. Moreover, the design of the LUCIA trial includes both treatment naïve and previously treated wet AMD patients, as well as re-dosing of DURAVYU every six months, which aligns well with how we would approach potential treatment using DURAVYU in clinical practice. We are proud to be the site to treat a patient with DURAVYU in the LUCIA trial and we look forward to continuing to work with EyePoint to rapidly enroll patients in this critical Phase 3 program.” LUGANO and LUCIA are global, randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including treatment naïve and treatment experienced patients. Each trial is expected to enroll approximately 400 patients globally who will be randomly assigned to a 2.7mg dose of DURAVYU or an on-label aflibercept control. The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal Phase 3 trials evaluating re-dosing in both trials. Patients in the DURAVYU treatment arm will receive an intravitreal injection of DURAVYU every six months, starting at month two of the trial. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT). More information about the trial is available at clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742). About Wet AMD Wet age-related macular degeneration (wet AMD) is a leading cause of vision loss and irreversible blindness in people over the age of 50. Wet AMD is an advanced form of condition that develops when abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss. About DURAVYU™ DURAVYUTM, f/k/a EYP-1901, is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. DURAVYU delivers vorolanib, a potent, selective and patent-protected tyrosine kinase inhibitor (TKI) as a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection and may have antifibrotic benefits as it also blocks PDGF. DURAVYU is shipped and stored at ambient temperature and is administered with a standard intravitreal injection in the physician's office. DURAVYU is immediately bioavailable with zero-order kinetics release for at least six months. Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of DURAVYU in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and CST and a favorable safety profile. Further, data from DAVIO 2 demonstrated an impressive treatment burden reduction of approximately 88% at eight months, six months after treatment with DURAVYU, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection through up to eight months, six months after treatment with DURAVYU. The data from the DAVIO 2 clinical trial supported the advancement of the wet AMD program and the initiation of the global Phase 3 clinical trials, LUGANO and LUCIA. DURAVYU is also currently being studied in the Phase 2 VERONA trial for diabetic macular edema (DME). Full topline data is expected in the first quarter of 2025. About EyePoint Pharmaceuticals EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding the timing and clinical development and potential of DURAVYU in wet AMD and DME, including our expectations regarding the pace of enrollment for the LUGANO trial and the LUCIA trial for wet AMD, and our beliefs and expectations regarding the anticipated announcement of full topline data from the VERONA trial in the first quarter of 2025; the belief that the interim results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials in DME; our beliefs and expectations regarding the anticipated full results from the VERONA trial; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in wet AMD and DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media Contact: Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com

Phase 3Phase 2Clinical ResultPhase 1

07 Nov 2024

·www.globenewswire.com

EyePoint Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Corporate Developments

– Announced positive interim data for DURAVYU 2.7mg in DME demonstrating meaningful, early and sustained visual acuity gains, strong anatomical control and a continued favorable safety profile; BCVA and CST improvement of +8.9 letters and -68 microns, respectively, at 16-weeks – – Dosed first patient in Phase 3 LUGANO pivotal non-inferiority clinical trial of DURAVYU™ in wet AMD; second LUCIA pivotal trial first patient dosing expected by end of 2024 – – $161.0 million oversubscribed equity financing extends cash runway into 2027 - WATERTOWN, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent corporate developments. “We made tremendous progress across our pipeline in recent months, including dosing the first patient in our first global pivotal trial of DURAVYU™ in wet AMD and reading out interim 16-week data for our Phase 2 VERONA trial in DME,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint. “Driven by positive clinical data in two indications, along with growing patient and investigator enthusiasm, we remain confident that DURAVYU’s differentiated profile underscores its potential to be the first sustained-release maintenance therapy in two significant indications, positioning EyePoint as the leader in sustained ocular drug delivery. This is an exciting time for EyePoint, and we anticipate dosing the first patient in the second Phase 3 LUCIA trial by the end of 2024. With a strong balance sheet and compelling clinical data, we are well-positioned to continue executing across our pipeline, working to bring our potentially paradigm-shifting treatment to patients as fast as possible.” R&D Highlights and Updates Announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU for diabetic macular edema (DME) in October. DURAVYU 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) with a gain of +8.9 letters compared to baseline versus +3.2 letters for aflibercept control. DURAVYU 2.7mg also demonstrated concomitant structural improvement with CST (central subfield thickness) improvement of 68.1 microns versus 30.5 microns for aflibercept control. Notably, both DURAVYU doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU with immediate bioavailability. Additionally, a favorable safety and tolerability profile continued for both DURAVYU arms. The Company expects to report the full topline results in the first quarter of 2025, once all patients complete the trial.Announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYUTM in wet age-related macular degeneration (wet AMD). The second Phase 3 LUCIA pivotal trial initiation is expected to have first patient dosing by end of 2024. The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials. With over 160 trial sites committed and robust DAVIO 2 data, the company anticipates rapid enrollment of both trials with topline data anticipated in 2026.Presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day in October, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September.Presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting in September, demonstrating the differentiation of DURAVYU with immediate bioavailability and controlled release via zero-order kinetics for at least six months.Presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting in August demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU. Recent Corporate Highlights Completed an underwritten public offering with gross proceeds of $161.0 million in October. The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share.Announced the grand opening of EyePoint’s Northbridge, MA manufacturing facility in October. The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and European Medicines Agency (EMA) and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYUTM upon potential regulatory approval.Announced the appointment of esteemed industry leader Fred Hassan to the Company’s Board of Directors in September. Review of Results for the Third Quarter Ended September 30, 2024 For the third quarter ended September 30, 2024, total net revenue was $10.5 million compared to $15.2 million for the quarter ended September 30, 2023. Net product revenue for the third quarter was $0.7 million, compared to net product revenues for the third quarter ended September 30, 2023, of $0.8 million. Net revenue from royalties and collaborations for the third quarter ended September 30, 2024, totaled $9.9 million compared to $14.4 million in the corresponding period in 2023. This decrease was primarily driven by lower recognition of deferred revenue related to the out-license of YUTIQ® product rights. Operating expenses for the third quarter ended September 30, 2024, totaled $43.3 million versus $29.6 million in the prior year period. This increase was primarily driven by (i) $5.4 million in costs related to the DURAVYU™ Phase 3 clinical trials for wet AMD, (ii) $3.8 million higher personnel expense for clinical and product development, including $2.1 million of non-cash stock compensation, (iii) $3 million in other R&D related expenses. Non-operating income, net, totaled $3.4 million and net loss was $29.4 million, or ($0.54) per share, compared to a net loss of $12.6 million, or ($0.33) per share, for the prior year period. Cash and investments at September 30, 2024 totaled $253.8 million compared to $331.1 million at December 31, 2023. Financial OutlookWe expect the cash, cash equivalents and investments on September 30, 2024, along with the net proceeds from the October $161.0 million equity financing will enable us to fund operations into 2027. About EyePoint Pharmaceuticals EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding the timing and clinical development and potential of DURAVYU in wet AMD and DME, including our expectations regarding the announcement of full topline data from the VERONA trial in the first quarter of 2025 and initiation of the LUGANO trial and the LUCIA trial; the belief that the interim results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; our beliefs and expectations regarding the anticipated full results from the VERONA trial; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media Contact: Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)(In thousands) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $79,830 $281,263 Marketable securities 173,963 49,787 Accounts and other receivables, net 378 805 Prepaid expenses and other current assets 11,571 9,039 Inventory 2,807 3,906 Total current assets 268,549 344,800 Operating lease right-of-use assets 21,405 4,983 Other assets 10,963 5,401 Total assets $300,917 $355,184 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $21,509 $24,025 Deferred revenue 25,996 38,592 Other current liabilities 1,289 646 Total current liabilities 48,794 63,263 Deferred revenue - noncurrent 11,234 20,692 Operating lease liabilities - noncurrent 21,922 4,906 Other noncurrent liabilities 233 - Total liabilities 82,183 88,861 Stockholders' equity: Capital 1,049,180 1,007,605 Accumulated deficit (831,617) (742,146)Accumulated other comprehensive income 1,171 864 Total stockholders' equity 218,734 266,323 Total liabilities and stockholders' equity $300,917 $355,184 $— $— EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSUnaudited(In thousands, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenues: Product sales, net $664 $816 $2,390 $13,483 License and collaboration agreements 9,561 14,137 27,906 17,768 Royalty income 299 249 1,389 739 Total revenues 10,524 15,202 31,685 31,990 Operating expenses: Cost of sales 736 1,202 2,896 3,634 Research and development 29,542 17,363 89,554 46,711 Sales and marketing 24 479 80 11,504 General and administrative 12,970 10,556 39,770 28,854 Total operating expenses 43,272 29,600 132,300 90,703 Loss from operations (32,748) (14,398) (100,615) (58,713)Other income (expense): Interest and other income, net 3,387 1,786 11,144 4,611 Interest expense - - - (1,247)Loss on extinguishment of debt - - - (1,347)Total other income, net 3,387 1,786 11,144 2,017 Net loss $(29,361) $(12,612) $(89,471) $(56,696)Net loss per common share - basic and diluted $(0.54) $(0.33) $(1.67) $(1.50)Weighted average common shares outstanding - basic and diluted 54,449 38,341 53,526 37,804

Clinical ResultPhase 3Phase 2Financial StatementExecutive Change

31 Oct 2024

·www.globenewswire.com

EyePoint Pharmaceuticals Announces Closing of Upsized Public Offering and Full Exercise of Option to Purchase Additional Shares

WATERTOWN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced the closing of its previously announced underwritten public offering of 14,636,363 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock, at the public offering price of $11.00 per share. Gross proceeds to EyePoint in the offering, before underwriting discounts and estimated expenses of the offering, were approximately $161.0 million. J.P. Morgan, Citigroup and Guggenheim Securities acted as joint book running managers for the offering. Baird, Mizuho and Jones acted as co-managers for the offering. EyePoint intends to use the net proceeds from the offering to advance clinical development of DURAVYU™ for wet age related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as support its earlier stage pipeline development initiatives, and for general corporate purposes. The securities described above were offered by EyePoint pursuant to a shelf registration statement on Form S-3 (No. 333-281391) previously filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and declared effective by the SEC on August 16, 2024. The securities were offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet AMD, the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in DME. EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the anticipated use of proceeds for the offering, EyePoint’s clinical development plans and the expected timing thereof; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy; the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investors:Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media ContactAmy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com

Phase 2Phase 3

100 Deals associated with Vorolanib

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15247

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	CN	Betta Pharmaceuticals Co., Ltd.	07 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	US	EyePoint Pharmaceuticals, Inc.	22 Oct 2024
Diabetic macular oedema	Phase 2	US	EyePoint Pharmaceuticals, Inc.	15 Jan 2024
Nonproliferative diabetic retinopathy	Phase 2	US	EyePoint Pharmaceuticals, Inc.	31 Aug 2022
Extensive stage Small Cell Lung Cancer	Phase 2	US	Xcovery Holding, Inc.	07 Oct 2020
Kidney Neoplasms	Phase 2	CN	Kananji Pharmaceutical Technology (Shanghai) Co., Ltd.	10 Mar 2017
Glycogen Storage Disease Type II	Phase 2	US	Tyrogenex, Inc.	16 Mar 2015
Macular Degeneration, Age-Related, 10	Phase 2	US	Tyrogenex, Inc.	16 Mar 2015
Adenocarcinoma	Phase 2	US	Tyrogenex, Inc.	03 May 2013
Neuroendocrine tumor of pancreas	Phase 2	US	Tyrogenex, Inc.	03 May 2013
Wet Macular Degeneration	Phase 2	US	Tyrogenex, Inc.	01 Oct 2012

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06099184 (VERONA, GlobeNewswire) Manual	Phase 2	Diabetic macular oedema	27	DURAVYU 2.7mg	khaodhfoho(bidrwcxpnt) = jgkxwhnadr fggasgcywo (ecdlbzhtdy ) View more	Positive	28 Oct 2024
				Aflibercept	khaodhfoho(bidrwcxpnt) = wysbrwtqjw fggasgcywo (ecdlbzhtdy ) View more
DAVIO 2 (EURETINA2024) Manual	Phase 2	Wet age-related macular degeneration	-	EYP-1901 2060µg	ctjwwzypje(umccecbrfb) = qozfykjsce zamtluyotc (yyugbskxgf ) View more	Non-inferior	19 Sep 2024
				EYP-1901 3090µg	ctjwwzypje(umccecbrfb) = wqlzdhuhae zamtluyotc (yyugbskxgf ) View more
DAVIO 2 (EURETINA2024) Manual	Phase 2	Wet age-related macular degeneration	-	EYP-1901 2060 μg dose	jwmeyjzqkc(hbbntuesis) = oqmwmhegyo nnyjdkosgm (lievlpgsjn ) View more	Non-inferior	19 Sep 2024
				EYP-1901 3090 μg dose	jwmeyjzqkc(hbbntuesis) = kjzoskkbij nnyjdkosgm (lievlpgsjn ) View more
NCT05383209 (PAVIA, Biospace) Manual	Phase 2	Nonproliferative diabetic retinopathy	77	DURAVYU 3mg	ugtdtuqurd(vuxpndxrrh) = bovdbibtrr ithhtctnvi (gqigdlbgjg ) Not Met View more	Positive	06 May 2024
				DURAVYU 2mg	ugtdtuqurd(vuxpndxrrh) = fsqfwapylu ithhtctnvi (gqigdlbgjg ) Not Met View more
NCT04747197 (DAVIO, Pubmed) Manual	Phase 1	Wet age-related macular degeneration	17	EYP-1901 440 μg	lisfopsypj(sgsddloyqp) = No dose-limiting toxicity, ocular serious adverse events (AEs), or systemic AEs related to EYP-1901 ccnsiefinu (tmekwienpa ) View more	Positive	01 Apr 2024
				EYP-1901 1030 μg
DAVIO 2 (NEWS) Manual	Phase 2	Wet age-related macular degeneration	161	EYP-1901 (2mg)	pyuwzkolms(vvxmwwvnuf) = fnxorjvpdx grkpnidcal (okdcdlhyom ) View more	Positive	05 Dec 2023
				EYP-1901 (3mg)	pyuwzkolms(vvxmwwvnuf) = asyygrjjut grkpnidcal (okdcdlhyom ) View more
NCT05381948 ( DAVIO 2, Corporate Publications) Manual	Phase 2	Wet age-related macular degeneration	-	EYP-1901 2mg	dqyeerpgyo(rlkjehlzfc) = acqyjvxtdw dfpmqanutn (hcrngcqxfe ) Met View more	Non-inferior	04 Dec 2023
				EYP-1901 3mg	dqyeerpgyo(rlkjehlzfc) = shmubjihas dfpmqanutn (hcrngcqxfe ) Met View more
DAVIO Trial (EURETINA2023)	Phase 1	Wet age-related macular degeneration anti-VEGF	-	EYP-1901 440 µg	jgrjshhygw(wfxmzqsjyl) = xfjhlrupxl xflpqfomex (ghnwabmpeh, 12.66) View more	Positive	05 Oct 2023
				EYP-1901 1,060 µg	jgrjshhygw(wfxmzqsjyl) = aayoxgjoep xflpqfomex (ghnwabmpeh, 13.59) View more
NCT05381948 (DAVIO 2, Corporate Publications) Manual	Phase 2	Wet age-related macular degeneration	-	EYP-1901 2 mg	iaexpzaytb(vtebnpevvm) = no reported drug-related ocular or systemic SAEs ezhlceoicp (exxuldelby )	Positive	11 Sep 2023
				EYP-1901 3 mg
NCT05383209 (PAVIA, Corporate Publications) Manual	Phase 2	Nonproliferative diabetic retinopathy	77	EYP-1901 2 mg	obudvbimcz(fnvpduooii) = no reported drug-related ocular SAEs and no reported drug-related systemic SAEs. There were two ocular SAEs deemed unrelated to EYP-1901 by investigators: Hemorrhagic posterior vitreous detachment (PVD) in a study eye eight weeks after dosing Macular edema leading to vision loss in the non-study fellow eye kzedamoofn (xkujmjbggg )	Positive	11 Sep 2023
				EYP-1901 3 mg

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