Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Start Date22 Dec 2022

Sponsor / Collaborator

Virginia Polytechnic Institute & State University

[+1]

CTRI/2022/07/044211 / Not yet recruitingPhase 3

A Multicentric Randomized Double Blind Double Dummy Parallel Group Two Arm Comparative Phase III Clinical Study to Evaluate Efficacy Safety and Tolerability of Loteprednol Etabonate Ophthalmic Suspension 1% w/v of Ajanta Pharma Ltd versus Loteprednol Etabonate Ophthalmic Suspension 0.5% w/v in treatment of Post-Operative Inflammatory conditions of Eye - Phase III

Start Date25 Jul 2022

Sponsor / Collaborator

Ajanta Pharma Ltd.

NCT05322148 / CompletedPhase 3

The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye

Start Date03 Jun 2022

Sponsor / Collaborator

Research Insight Finland Oy

100 Clinical Results associated with Loteprednol Etabonate

100 Translational Medicine associated with Loteprednol Etabonate

100 Patents (Medical) associated with Loteprednol Etabonate

237

Literatures (Medical) associated with Loteprednol Etabonate

01 Feb 2024·American journal of ophthalmology

United States Regulatory Approval of Topical Treatments for Dry Eye

Review

Author: Li, Gavin ; Cui, David ; Lin, Michael X ; Akpek, Esen K ; Mathews, Priya M ; Saldanha, Ian J

PURPOSE:

To report the heterogeneity in methodology of clinical trials submitted to the US Food and Drug Administration (FDA) for approval of topical dry eye treatments.

DESIGN:

Comparative analysis of clinical trials' methods.

METHODS:

We reviewed the online, publicly available FDA database, application review files, ClinicalTrials.gov registry records, and journal articles for each FDA-approved topical dry eye treatment. For each trial, we extracted information about the study, patient demographics, treatment names and doses, sample size in each arm, and the measurement instrument in a systematic fashion.

RESULTS:

Fourteen trials were included that assessed 5 topical treatments for dry eye (cyclosporine 0.05%, cyclosporine 0.09%, lifitegrast 5%, and loteprednol 0.25% eye drops and varenicline 0.03-mg nasal spray). Median treatment duration was 12 weeks (range, 2-24 weeks). In all trials, treatments, including varying concentrations of the same treatment, were compared with vehicle. Twelve trials (85.7%) evaluated a primary clinician-measured clinical sign, and 10 trials (71.4%) evaluated a primary patient-reported symptom. Corneal staining was the most frequently evaluated clinical sign primary outcome, reported in half (6 of 12) of the trials, and was graded using 4 different scoring systems. Conjunctival staining, conjunctival hyperemia, and tear production were each measured using 2 different scoring systems. Ocular discomfort, the only patient-reported symptom primary outcome, was measured using 5 different instruments.

CONCLUSION:

A variety of outcome measures were used in these clinical trials. Clinically meaningful dry eye outcome measures and standardized measurements can optimize the assessment of and comparison of therapeutic benefits.

01 Oct 2023·Assay and drug development technologies

Determination of the Toxicity Preferences of Ocular Drug Delivery System by Comparing Two Different Toxicity Bioassays.

Article

Author: Uner, Melike ; Tas, Cetin ; Durgun, Meltem Ezgi ; Ozsoy, Yildiz ; Uner, Burcu ; Ozdemir, Samet

Ocular drug delivery methods are highly favored for boosting bioavailability, patient compliance, and lower adverse effects and dose frequency. In addition to preventing adverse effects from the active ingredient, the parts of drug delivery systems must be nontoxic and nonallergic as well. Mitochondrial toxicity test (MTT) and Hen's egg chorioallantois membrane (HET-CAM) assay are the most often utilized tests based on this dilemma. The toxicity of loteprednol etabonate loaded solid lipid nanoparticles, lipid nanostructured carriers, and nanoemulsion were compared. Oleic acid, Precirol^®ATO5, and Pluronic^® F68 were used in the preparation. Their toxicities were evaluated by using two different toxicity tests (MTT and HET-CAM). The results suggest that there are no significant differences between the HET-CAM and MTT assays. It is noteworthy that the HET-CAM assay offers a more cost-effective and environmentally friendly alternative to the MTT assay, as it does not require cell culture and generates less toxic waste. This information may be useful to consider when selecting between the two assays.

21 Sep 2023·Cornea

Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy.

Article

Author: Feng, Matthew T ; Price, Marianne O ; Gang, Anjulie ; Price, Francis W

PURPOSE:

The purpose of this study was to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension for prevention of immunologic rejection after Descemet membrane endothelial keratoplasty (DMEK).

METHODS:

This prospective, open-label study enrolled 70 eyes of 70 participants without preexisting glaucoma 1 month after DMEK. Participants used topical loteprednol 0.25% 4 times daily for 2 months, tapered by 1 drop/month to once daily use, and continued use through 1 year after DMEK. Main outcomes were rate of intraocular pressure (IOP) elevation (defined as a relative increase of ≥10 mm Hg over the pretransplant IOP) and rate of initial allograft rejection episodes. The results were compared with historical data using the log-rank test.

RESULTS:

All participants had Fuchs dystrophy, and 40 of 70 (57%) were female. None (0%) experienced an immunologic graft rejection episode, matching the previously reported efficacy of prednisolone acetate 1% suspension and loteprednol 0.5% gel (both 0% incidence). One study eye developed IOP elevation 3 months after DMEK (cumulative risk 1.5%). Compared with historical data, this was similar to the risk with loteprednol 0.5% gel (4%, P = 0.36) and significantly lower than the risk with prednisolone 1% suspension (18%, P = 0.0025). Two participants (3%) complained of instillation site discomfort, consistent with the 5% rate reported on package labeling.

CONCLUSIONS:

Loteprednol 0.25% suspension, approved for short-term treatment of dry eyes, effectively prevented immunologic rejection episodes with minimal risk of IOP elevation when used from 1 month until 12 months after DMEK in patients without preexisting glaucoma.

News (Medical) associated with Loteprednol Etabonate

28 May 2024

·www.biospace.com

Bausch + Lomb Announces Presentation of New Scientific Data and Evaluations Featuring Consumer, Vision Care and Pharmaceutical Products at Optometry’s Meeting®

15 ePosters and In-Person Presentations Will Include Clinical Data on Blink™ NutriTears® Supplement for Dry Eyes, Blink® Triple Care Lubricating Eye Drops and MIEBO® (Perfluorohexyloctane Ophthalmic Solution) VAUGHAN, Ontario--(BUSINESS WIRE)-- Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the presentation of 12 ePosters during the American Optometric Association (AOA) Optometry’s Meeting ePoster Session, taking place virtually May 29-30, 2024. The company will also have three live presentations and host nine education events during the in-person meeting, taking place in Nashville June 19-22, 2024. The OnDemand ePosters will feature new data on the early adoption of MIEBO and real-world patient experiences with Bausch + Lomb INFUSE® Multifocal silicone hydrogel daily disposable contact lenses. An evaluation of the performance of Biotrue® Hydration Plus Multi-Purpose Solution among two different patient demographics – soft contact lens wearers who are also frequent gamers and users planning to stop wearing lenses due to discomfort – will also be highlighted. The live, in-person presentations will include clinical data evaluating Blink NutriTears clinically proven nutritional supplement for dry eyes*, which was selected by AOA as one of the top five Optometry’s Meeting abstracts. Two other presentations will showcase clinical evaluation data for Blink Triple Care Lubricating Eye Drops, the first and only over-the-counter eye drop with both hyaluronate and a nano-emulsion lipid in the unique formula. The complete list of scientific ePosters and live presentations, as well as details for the featured education events, is as follows: e-Poster Presentations “A Multi-country Assessment of Satisfaction with a Spherical Silicone Hydrogel Daily Disposable Contact Lens Among New Contact Lens Wearers and Their Eyecare Professionals.” Reindel et al. “Comparison of Clinical Studies from the US and India of a Multi-Ingredient Oral Supplement.” Gioia et al. “Early Adoption and Utilization of Perfluorohexyloctane for Dry Eye Disease.” Alexander et al. “Evaluation of the Efficacy of a Novel Preservative-Free Formulation of Brimonidine Tartrate Ophthalmic Solution.” Evans et al. “Evaluation of the Safety of a Novel Preservative-Free Formulation of Brimonidine Tartrate Ophthalmic Solution.” Evans et al. “Frequent Gamers Tag a Novel Contact Lens Solution with High Satisfaction” Shahidi et al. “Improvement in Non-Invasive Tear Break-Up Time after Instillation of One Drop of Brimonidine Tartrate 0.025%.” Moore et al. “Ocular Vasoconstrictors: Does Mechanism of Action Make a Difference?” Moore et al. “On the Verge of Dropout: An In-Home Use Test of a Novel Contact Lens Solution Among Planned Replacement Contact Lens Wearers.” Shahidi et al. “Patient Performance Assessment with Multifocal Toric Silicone Hydrogel Contact Lenses.” Rah et al. “Patient-reported Instillation Comfort and Eyedrop Acceptability of Perfluorohexyloctane Ophthalmic Solution in Pivotal Clinical Studies.” Cunningham et al. “Real-world Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens.” Rah et al. Live Presentations “Clinical Evaluation of a Novel Lipid-Containing Eye Drop.” Coats et al. “Clinical Evaluation of a Multi-Ingredient Oral Supplement on Dry Eye Symptoms and Tear Volume.” Gioia et al. “Comparison of a Novel Lipid Nano-Emulsion Eye Drop with an Existing Lubricating Eye Drop.” Coats et al. Featured Education Events Wednesday, June 19 “Showcasing Inflammation and IOP Control with Bausch + Lomb” 6:30 p.m. CDT at The Palm (140 5th Avenue South, Nashville, Tenn.) Nora Lee Cothran, OD, FAAO, and Walter Whitley, OD, FAAO, will discuss the benefits of using LOTEMAX® SM (loteprednol etabonate ophthalmic gel), 0.38%, and VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%. Register in advance. Thursday, June 20 “Showcasing Inflammation and IOP Control with Bausch + Lomb” 8:00-9:00 a.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; room #104AB) Richard Madonna, OD, and Justin Schweitzer, OD, will discuss the benefits of using LOTEMAX SM (loteprednol etabonate ophthalmic gel), 0.38%, and VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%. “NEW Breakthrough Supplement for Dry Eyes from Bausch + Lomb: Blink NutriTears” 12:00-1:00 p.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; room #104AB) Selina McGee, OD, FAAO, and Julie Poteet, OD, will lead a conversation on the new Blink NutriTears, a breakthrough, nutritional daily supplement for dry eyes. “Current Thinking in Dry Eye Disease: Contemporary Perspectives on a Complex Condition” 6:30-8:30 p.m. CDT at Morton’s Steakhouse (618 Church Street, Nashville, Tenn.) Learn about MIEBO, the first and only prescription eye drop that directly targets tear evaporation, as well as XIIDRA® (lifitegrast ophthalmic solution), 5%, the only nonsteroid anti-inflammatory prescription eye drop that can start to deliver dry eye symptom relief in just two weeks.1-2 Register in advance. “A NightCap in Nashville with Blink NutriTears” 8:00-10:30 p.m. (presentation at 9:00 p.m. CDT) at The Bell Tower (400th Ave. S, Nashville, Tenn.) Join Cecelia Koetting, OD, FAAO, to lean about Blink NutriTears clinically proven nutritional supplement for dry eyes. Friday, June 21 “Rethinking Dry Eye Disease: A Contemporary Approach to a Complex Condition” 8:00-9:00 a.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; room #104AB) Cecelia Koetting, OD, FAAO, and Nathan Lighthizer, OD, FAAO, will discuss the benefits of and differences between MIEBO and XIIDRA. “The Science of Eye Beauty with LUMIFY EYE ILLUMINATIONS™” 12:40-1:00 p.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; Exhibit Hall, Eye Talks Stage) Join Selina McGee, OD, FAAO, to learn about LUMIFY EYE ILLUMINATIONS, a clinically proven specialty eye care line. Saturday, June 22 “A Family of Eye Care Products with Innovations for Every Stage of Life” 9:00-10:00 a.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; room #104AB) Selina McGee, OD, FAAO, Mitch Ibach, OD, FAAO, and John Womack, OD, will share practical patient cases using products from across the Bausch + Lomb consumer, vision care and pharmaceutical portfolios. “The Puzzle of Dry Eye: Targeted Approaches to a Multifactorial Condition” 12:00-1:00 p.m. CDT at the Music City Center (201 Rep. John Lewis Way S, Nashville, Tenn.; room #104AB) Learn about the complex dry eye puzzle, Blink NutriTears, as well as MIEBO and XIIDRA. AOA’s Celebration of Optometry Event Additionally, Bausch + Lomb is the title sponsor of AOA’s Celebration of Optometry event, taking place at FGL House (120 3rd Ave South, Nashville, Tenn.) at 7 p.m. CDT on Friday, June 21. During the event, attendees will have the opportunity to learn about Bausch + Lomb’s latest innovations, including Bausch + Lomb INFUSE® for Astigmatism and Blink NutriTears. Important Safety Information for MIEBO INDICATION MIEBO (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting. It is important for patients to use MIEBO exactly as prescribed. It is not known if MIEBO is safe and effective in children under the age of 18. The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information for MIEBO. WHAT IS XIIDRA? XIIDRA (lifitegrast ophthalmic solution) 5% is a prescription eye drop used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION Do not use XIIDRA if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction. The most common side effects of XIIDRA include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and an unusual taste sensation. To help avoid eye injury or contamination of the solution, do not touch the container tip to your eye or any surface. If you wear contact lenses, remove them before using XIIDRA and wait for at least 15 minutes before placing them back in your eyes. It is not known if XIIDRA is safe and effective in children under 17 years of age. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information for XIIDRA. Important Safety Information for LOTEMAX SM INDICATION LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. IMPORTANT SAFETY INFORMATION LOTEMAX SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If LOTEMAX SM is used for 10 days or longer, IOP should be monitored. Use of corticosteroids may result in posterior subcapsular cataract formation. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those with diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. Contact lenses should not be worn when the eyes are inflamed. There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. Click here for full Prescribing Information for LOTEMAX SM. Important Safety Information for VYZULTA INDICATION VYZULTA (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. IMPORTANT SAFETY INFORMATION Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation. Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation. Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients. Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration. Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). Please click here for full Prescribing Information. Patients are encouraged to report negative side effects of these prescription drugs to the FDA. Visit or call 1-800-FDA-1088. About Bausch + Lomb Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit and connect with us on X, LinkedIn, Facebook and Instagram. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “will,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. References XIIDRA significantly reduced symptoms of eye dryness at 2 weeks in two out of four clinical studies. XIIDRA. Prescribing information. Bausch & Lomb Inc; 2023. © 2024 Bausch + Lomb. BLS.0079.USA.24 View source version on businesswire.com: Contacts Investor Contact: George Gadkowski george.gadkowski@bausch.com (877) 354-3705 (toll free) (908) 927-0735 Source: Bausch + Lomb Corporation View this news release online at:

01 Feb 2024

·www.biospace.com

Opthea Strengthens Team with Key Clinical and Regulatory Hires

Dr. Julie Clark, SVP Clinical Development; Dr. Fang Li, SVP Regulatory Affairs, to join February 1st Experienced executives bring extensive track record in products for retinal and ophthalmology diseases MELBOURNE, Australia, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced the appointment of Julie Clark, MD, MS, as Senior Vice President (SVP), Clinical Development, and Fang Li, Ph.D. RAC, as SVP, Regulatory Affairs, effective February 1, 2024. Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team. “It is my great pleasure to welcome two ophthalmology experts, Dr. Clark and Dr. Li, to the Company as we prepare for the next stage in our growth and work towards advancing the development of sozinibercept (OPT-302),” said Dr. Guerard. “Their past contributions to the development and registration of ophthalmology therapies such as IZERVAY™, BEOVU®, and EYLEA®, will be instrumental to the potential success of our lead program investigating sozinibercept, currently in two Phase 3 pivotal trials.” Dr. Clark shared, “I am thrilled to join Opthea as we prepare to complete patient enrollment in the pivotal Phase 3 clinical program for sozinibercept in the first half of 2024. The majority of my career has been dedicated to the clinical development of novel therapies for retinal diseases. Sozinibercept could be the first new drug for wet age-related macular degeneration (AMD) in more than 15 years, with the potential to deliver superior visual gains when administered in combination with standard of care therapy. I look forward to contributing to bringing this novel product candidate to patients with serious retinal disease.” Dr. Li commented, “As we work towards the potential release of topline results for our Phase 3 program in mid-2025, I am excited to apply my expertise to support the development and execution of our regulatory strategy and potential filings for sozinibercept in the U.S. and other markets. I look forward to the opportunity to bring Opthea’s innovative potential medicine through the regulatory process for the benefit of patients with retinal diseases.” Julie Clark, MD, MS With more than 15 years of experience in ophthalmology medical and clinical development, Dr. Clark brings expertise in both early and late-stage programs, regulatory submissions, and approvals. Her contributions include substantial support for the approval and launches of retinal therapies such as EYLEA®, JETREA® and BEOVU®. In Dr. Clark’s most recent position as Vice President Clinical Development at IVERIC bio, Inc., An Astellas Company, she oversaw the development program leading to the August 2023 U.S. Food and Drug Administration (FDA) approval of IZERVAY™, a complement inhibitor approved for the treatment of geographic atrophy secondary to age-related macular degeneration. Dr. Clark previously served as Chief Medical Officer at Adverum Biotechnologies Inc, where she played a crucial role in developing intravitreal delivered gene therapy for retinal diseases. Dr. Clark is a graduate of Wake Forest University and Wake Forest University School of Medicine in Winston-Salem, NC, U.S. Fang Li, PhD, RAC Dr. Li brings over 30 years of expertise in drug development and more than 20 years in regulatory affairs experience. Her experience spans various domains including small molecules, biologics, gene therapy, over-the-counter products, in-vitro diagnostic products and medical devices, with a specific focus on ophthalmology. She has held key roles at prominent ophthalmology companies such as Novartis AG, Alcon Inc., and Bausch + Lomb Corporation. Dr. Li's extensive background includes significant involvement in health authority interactions, U.S. FDA advisory committee meeting preparation and the establishment and leadership of regulatory teams. She has a proven track record of success in obtaining product approvals in the U.S. and other regions. Throughout her career, Dr. Li has played a pivotal role in leading numerous FDA drug approvals, specifically contributing to the approval of ophthalmology products like JETREA®, LOTEMAX® Ointment, SYSTANE® COMPLETE. She has also contributed to the development and registration of other ophthalmology drug products such as BEOVU®, PAZEO®, LOTEMAX® GEL, BESIVANCE®, and VYZULTA®. Fang holds a PhD in Medicinal Chemistry from China Pharmaceutical University, China. About Opthea Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including neovascular (wet) age-related macular degeneration (wet AMD). Opthea’s lead product candidate sozinibercept is being evaluated in two pivotal Phase 3 clinical trials (ShORe, NCT04757610, and COAST, NCT04757636) 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. To learn more, visit 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 expectations on the outcomes of Opthea’s Phase 3 clinical trials of sozinibercept, the potential for sozinibercept as a combination therapy to be the first therapy to achieve superior visual outcomes over anti-VEGF-A monotherapy and improve vision outcomes for patients with wet AMD, the expected timing for completion of enrollment for the Phase 3 studies and topline data, the market opportunity for sozinibercept, and the future performance of Opthea. 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 development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of Phase 3 clinical trial patient enrollment and clinical research organization 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 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. Authorized for release to ASX by Frederic Guerard, CEO Company & Media Enquiries: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333 Investor Enquiries PJ Kelleher LifeSci Advisors Email: pkelleher@lifesciadvisors.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web:

Phase 3Executive ChangeDrug Approval

09 Jan 2024

·www.biospace.com

Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye

AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001) Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription product1 GENEVA--(BUSINESS WIRE)-- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED). In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score (a measure of tear production) achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512. “We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide Eye Care Professionals (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” said David Endicott, CEO of Alcon. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.” AR-15512 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This represents the significant need for an effective chronic treatment that can provide rapid natural tear production.1 In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported. “A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of Cincinnati, a key advisor on COMET-2 and -3 and Senior Scientific Advisor at Alcon. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies and it represents a first-in-class candidate for chronic dry eye.” AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024. Alcon's ophthalmic pharmaceutical portfolio currently includes Rocklatan®, Rhopressa®, Simbrinza®, Eysuvis®, and Inveltys®. About Dry Eye Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the United States and an estimated 719 million more adults globally.1 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.2 Many existing prescription options for dry eye disease are generally regarded by many eye care professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.3 About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at . Cautionary Note Regarding Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. References Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov) Improved Dry Eye Drugs for 2022 and Beyond; Connect with us on Facebook LinkedIn

Clinical ResultPhase 3Phase 1NDA

100 Deals associated with Loteprednol Etabonate

External Link

KEGG	Wiki	ATC	Drug Bank
D01689	Loteprednol Etabonate	S01BA14	DB14596

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dry Eye Syndromes	US	Alcon Laboratories, Inc.	26 Oct 2020
Pain	US	Bausch & Lomb, Inc.	15 Apr 2011
Conjunctivitis, Allergic	CN	Bausch & Lomb, Inc.	10 Jan 2007
Herpes Zoster Ophthalmicus	CN	Bausch & Lomb, Inc.	10 Jan 2007
Keratitis	CN	Bausch & Lomb, Inc.	10 Jan 2007
Cyclitis	US	Bausch & Lomb, Inc.	09 Mar 1998
Iritis	US	Bausch & Lomb, Inc.	09 Mar 1998
Keratitis, Herpetic	US	Bausch & Lomb, Inc.	09 Mar 1998
Ocular inflammation	US	W World Corp.	09 Mar 1998
Post procedural inflammation	US	Bausch & Lomb, Inc.	09 Mar 1998
Rosacea	US	Bausch & Lomb, Inc.	09 Mar 1998
Seasonal allergic conjunctivitis	US	Bausch & Lomb, Inc.	09 Mar 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kerato conjunctivitis sicca	Phase 3	US	KALA BIO, Inc.	01 Jun 2016
Cataract	Phase 3	US	Bausch & Lomb, Inc.	01 Jun 2013
Blepharitis	Phase 3	SG	Bausch & Lomb, Inc.	01 Oct 2009
Blepharokeratoconjunctivitis	Phase 3	SG	Bausch & Lomb, Inc.	01 Oct 2009
Meibomian Gland Dysfunction	Phase 2	US	KALA BIO, Inc.	01 Jul 2014
Postoperative Complications	Phase 1	CA	Sandoz International GmbH	26 Apr 2018
Eye Pain	Phase 1	US	Bausch Health Americas, Inc.	01 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04555694 (CTgov)	Phase 4	Dry Eye Syndromes	30	Cyclosporine+Loteprednol Etabonate (Restasis and Lotemax)	txwzprwepb(swvgwhapvy) = qwzwcruovr jebmqnkbyq (qmesajbvcy, sxagawkstp - ezjbgjvvts) View more	-	11 Oct 2023
				Cyclosporine+Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert (Restasis and Dextenza)	txwzprwepb(swvgwhapvy) = ktqqepnslb jebmqnkbyq (qmesajbvcy, mijknyiccc - xbdunkypdq) View more
NCT02120079 (CTgov)	Phase 4	Dry Eye Syndromes	38	In Vivo Confocal Microscopy (IVCM)+Lotemax (Lotemax)	cvulfqastj(gqoqpbqsmq) = tbojfjmwbo zrzpaynqfv (gvuizhpngr, vijzbcizrw - vvqrulvzwu) View more	-	23 Mar 2022
				In Vivo Confocal Microscopy (IVCM)+Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) (Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears))	cvulfqastj(gqoqpbqsmq) = xdznijawpz zrzpaynqfv (gvuizhpngr, unxbdrcbwx - lfhhrfchim) View more
AAO2021	Not Applicable	Nummular eczema	100	Tacrolimus 0.1%	syorfagxpz(jrhmdbvlat) = qesvrzqzwu bmwgkfuyxe (kmflbcufdx )	-	13 Nov 2021
				Loteprednol 0.5%	syorfagxpz(jrhmdbvlat) = ndnfujnbax bmwgkfuyxe (kmflbcufdx )
ARVO2021	Not Applicable	-	-	Loteprednol Etabonate Eluting Adhesive Ocular Patch	cqcycmfcxm(kbpojqhwlv) = lhungeqhuw xvdvylpbqo (wdltykkvtz ) View more	-	01 Jun 2021
ARVO2021	Not Applicable	-	-	Loteprednol etabonate (submicron) ophthalmic gel 0.38%	hffhaszqcv(ridukzxazq) = bnjbtwvtdz vayiujatki (frmxlxhabl, 1.3)	-	01 Jun 2021
				Prednisolone acetate ophthalmic suspension 1.0%	hffhaszqcv(ridukzxazq) = bzsirtekxb vayiujatki (frmxlxhabl, 1.39)
NCT03616899 (CTgov)	Phase 3	Kerato conjunctivitis sicca	901	KPI-121 Ophthalmic Suspension (KPI-121 0.25% Ophthalmic Suspension)	znyjvewkcb(clvwynceyf) = etztyqbchg dsdnouubhz (hskhfgnadf, usjysojlnj - roerowbunn) View more	-	02 Apr 2021
				Vehicle (Vehicle of KPI-121 0.25% Ophthalmic Suspension)	znyjvewkcb(clvwynceyf) = nmfuojhfya dsdnouubhz (hskhfgnadf, yosayseqrh - mbwpwxtqrk) View more
NCT02218489 (CTgov)	Phase 2	Blepharitis \| Meibomian Gland Dysfunction	206	Vehicle (Vehicle)	ehuykbidqy(gfgbsoecie) = fjocknvalg borcyimfgo (wdpanshots, zqkkukptxu - ajujoscxxp) View more	-	11 Jan 2021
				KPI-121 (KPI-121 0.25% Ophthalmic Suspension)	ehuykbidqy(gfgbsoecie) = dqrfcqqsfr borcyimfgo (wdpanshots, ehtxphzkdu - kzuddmxteh) View more
NCT02188160 (CTgov)	Phase 2	Kerato conjunctivitis sicca	150	KPI-121 (KPI-121 0.25% Ophthalmic Suspension)	nmlqcfyrjv(zlysnttlfx) = bzvxmxpybd plsqqykalf (tybhdpzbuh, pyhchsgtrr - dawcjjftpo) View more	-	06 Jan 2021
				Placebo (Vehicle)	nmlqcfyrjv(zlysnttlfx) = mnytbetxpc plsqqykalf (tybhdpzbuh, zuczcoxzuw - svgvcqwdlh) View more
NCT02163824 (CTgov)	Phase 3	Post procedural inflammation \| Eye Infections	380	KPI-121 0.25% (KPI-121 0.25% QID)	dtihuyyblg(vnlamcoonc) = awbnlisxgg noldprqyyu (zfiaoyglmv, cbbckmkqpf - yvmhmzviuo) View more	-	22 Dec 2020
				KPI-121 1.0% (KPI-121 1.0% BID)	dtihuyyblg(vnlamcoonc) = yldsnytqiu noldprqyyu (zfiaoyglmv, sxwsbiugxu - kcxqovsutm) View more
NCT03123614 (CTgov)	Phase 4	Corneal Opacity	131	Loteprednol Etabonate 0.5% Oph Gel (Loteprednol Etabonate 0.5% Oph Gel)	ttbjjcnebb(irxffebpfj) = mtjqjmvhmk ijdbvismda (nxhrvbemfw, abczubnhuy - tyvzeoydmd) View more	-	21 Dec 2020
				Prednisolone Acetate 1% Oph Susp (Prednisolone Acetate 1% Oph Susp)	ttbjjcnebb(irxffebpfj) = onwxwstpqr ijdbvismda (nxhrvbemfw, wkzdfutdvy - zbduktpiwg) View more

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