Summary of EyePoint Pharmaceuticals (EYPT) Conference Call - September 02, 2025 Company Overview - EyePoint Pharmaceuticals specializes in drug delivery systems for ocular diseases, particularly focusing on wet age-related macular degeneration (AMD) [2][3] - The company has developed a fully bioerodable insert containing Verolanib, a small molecule tyrosine kinase inhibitor targeting all VEGF receptors [2] Key Trials and Market Potential - EyePoint is currently conducting two identical Phase 3 trials for wet AMD, with a market size of approximately $10 billion annually in the U.S. [2][3] - Both trials have been fully enrolled, achieving the fastest enrollment rates on record for wet AMD trials, approximately seven months [3][4] - The primary endpoint of the trials is non-inferiority in visual acuity compared to aflibercept (Eylea) [2][20] Enrollment and Trial Design - The company attributes the rapid enrollment to strong Phase 2 data and effective trial design, including a patient-centric approach [3][12] - The trials include rescue criteria for patients losing vision, allowing supplemental injections to prevent long-term vision loss [12][16] Expected Outcomes and Safety - The non-inferiority margin is set at -4.5 letters, with previous Phase 2 data showing a lower limit of around 2.6 letters [21] - Over 190 patients have been treated with no ocular or systemic serious adverse events (SAEs) attributed to the drug or insert [22] - The Data Safety Monitoring Committee has recommended no changes to the trial protocols, indicating no unexpected safety issues [22] Treatment Burden and Commercial Success - A significant reduction in treatment burden is expected, with Phase 2 data indicating an 80% reduction compared to Eylea [22][23] - The company aims for at least a 50% reduction in treatment burden to achieve commercial success [23] Integration into Clinical Practice - The expected administration interval for the new treatment is six months, with potential for some patients to go a full year without additional injections [25][26] - The treatment strategy will likely involve a combination of existing anti-VEGF therapies and the new insert, allowing for individualized patient care [28][49] Manufacturing and Supply Capacity - EyePoint's manufacturing facility in Northbridge, Massachusetts, is capable of producing nearly one million inserts annually, sufficient to meet global demand [41][42] - The facility is being prepared for FDA inspection and potential commercial launch [42] Competitive Positioning - EyePoint believes it is positioned to be the first to file for approval among competitors developing long-acting inserts for wet AMD, with a potential launch by the end of 2027 [34][35] Future Developments - The company plans to initiate pivotal trials for diabetic macular edema (DME) in 2026, following successful Phase 2 results [57][58] - EyePoint is also exploring opportunities in other retinal diseases, although financial considerations have led to the discontinuation of some programs [66] Upcoming Catalysts - Key upcoming events include presentations at eye meetings and updates on safety and demographic data from the Phase 3 trials [68][69] - The company plans to release data from the two Phase 3 trials separately to maximize impact [70] Conclusion - EyePoint Pharmaceuticals is on track to potentially revolutionize the treatment of wet AMD with its innovative drug delivery system, backed by strong trial data and a robust manufacturing strategy [2][34][42]

– Interim analysis by independent Data Safety Monitoring Committee (DSMC) confirmed no changes to Phase 3 protocol and recommended continuation of trial as planned – – LUCIA pivotal Phase 3 trial enrolled and randomized over 400 patients in seven months, demonstrating continued strong enthusiasm for the DURAVYU pivotal program across the global retinal community – – Over 800 patients enrolled across the LUGANO and LUCIA trials of DURAVYU, representing one of the fastest enrolling Phase 3 pivotal programs fo ...

About EyePoint EyePoint Pharmaceuticals, Inc. (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™ is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining ...

Core Insights - EyePoint Pharmaceuticals has enrolled over 400 patients in the Phase 3 LUGANO trial for DURAVYU, surpassing its enrollment target and indicating strong interest from both physicians and patients [1][3] - The LUGANO trial is part of a pivotal Phase 3 program designed in alignment with the FDA, with topline data expected in mid-2026 [2][3] - DURAVYU aims to provide a sustained-release treatment option for wet age-related macular degeneration (wet AMD), addressing significant patient needs and market potential [3][5] Company Overview - EyePoint Pharmaceuticals is focused on developing innovative therapeutics for serious retinal diseases, leveraging its proprietary Durasert E™ technology for sustained intraocular drug delivery [9][10] - The lead product candidate, DURAVYU, is a sustained delivery treatment for VEGF-mediated retinal diseases, utilizing vorolanib, a selective tyrosine kinase inhibitor [6][9] - The company has established a robust safety and efficacy profile for DURAVYU, with positive results from previous clinical trials demonstrating significant treatment burden reduction [7][9] Clinical Trials - The LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials assessing DURAVYU's efficacy and safety in wet AMD patients [3][4] - The LUGANO trial has completed enrollment, while the LUCIA trial is expected to complete enrollment by the third quarter of 2025 [1][3] - Both trials are designed to evaluate the average change in best corrected visual acuity (BCVA) and other secondary endpoints over a two-year period [3][4] Market Context - Wet AMD is a leading cause of vision loss in individuals over 50, requiring continuous treatment and posing a significant burden on patients and healthcare systems [5] - Current treatments require frequent dosing, which can lead to patient noncompliance and further vision loss, highlighting the need for innovative solutions like DURAVYU [5][6] - The potential for DURAVYU to transform the treatment paradigm for wet AMD is underscored by its unique delivery mechanism and favorable safety profile [3][6]

Core Insights - EyePoint Pharmaceuticals, Inc. is set to host a conference call on May 7, 2025, to discuss its Q1 2025 financial results and recent corporate developments [1] - The company focuses on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary Durasert E™ technology for sustained intraocular drug delivery [3][4] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Watertown, Massachusetts, with a commercial-ready manufacturing facility in Northbridge, Massachusetts [4] - The lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and has completed a Phase 2 trial for diabetic macular edema (DME) [3][5] Pipeline and Technology - The company's pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - Durasert technology has been safely administered to thousands of patient eyes across four FDA-approved products for various disease indications [4] Licensing and Regulatory Status - Vorolanib, the active ingredient in DURAVYU™, is exclusively licensed to EyePoint by Equinox Sciences for the treatment of ophthalmic diseases outside of specific Asian markets [5] - DURAVYU™ has received conditional acceptance from the FDA as the proprietary name for EYP-1901, but it remains investigational and has not yet been approved by the FDA [5]