– DURAVYU now in Phase 3 for the two largest, multi-billion-dollar retinal disease markets, wet AMD and DME with first patient dosing in pivotal Phase 3 DME trials anticipated in Q1 2026 – – New preclinical data demonstrates that vorolanib, the active drug in DURAVYU, inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, key contributors to wet AMD and DME –  – IL-6 finding supports the compelling efficacy data observed in the Phase 2 VERONA DME trial and underscores DURAVYU as a ...

Company Overview - EyePoint specializes in drug delivery systems for the back of the eye, with four FDA-approved products utilizing its technology [2] - The latest innovation is a fully bioerodible insert containing vorolanib, a small molecule tyrosine kinase inhibitor targeting all VEGF receptors [2] Industry Context - The company is currently conducting two Phase III trials for wet age-related macular degeneration (AMD), which represents the largest market among retinal vascular diseases, valued at approximately $10 billion annually in the United States [3] - Both trials are fully enrolled and are designed to assess noninferiority in visual acuity changes compared to the on-label aflibercept control [3]

Summary of EyePoint Pharmaceuticals (EYPT) FY Conference - August 13, 2025 Company Overview - **Company**: EyePoint Pharmaceuticals - **Focus**: Development of sustained-release therapies for ocular diseases, specifically targeting wet age-related macular degeneration (AMD) with their drug Duravu Key Points and Arguments Clinical Trials and Drug Development - **Phase Three Trials**: Both Lugano and Lucia trials for Duravu have completed enrollment, including treatment naive and treatment experienced patients, which is expected to positively impact future data readouts [3][4][5] - **Patient Population**: The trials have a 75% treatment naive to 25% previously treated patient ratio, which is considered advantageous for FDA evaluation [8][10][12] - **Safety Profile**: No safety signals were observed in previous trials, and the inclusion of naive patients is not expected to alter safety outcomes [6][42] - **Supplemental Injections**: The criteria for supplemental injections have been simplified based on phase two findings, aiming to reduce the supplemental rate in pivotal trials [13][15][17] Drug Technology - **DuraCert e Technology**: The new bioerodible DuraCert e technology differs from previous DuraCer technology by eliminating the polyamide shell, which is expected to enhance safety and efficacy [20][22][26] - **Drug Composition**: The inserts are now 94% drug and 6% matrix, designed to fully bioerode without leaving harmful residues [27][28][32] Market Expectations and Competitive Landscape - **Regulatory Pathway**: Vorolanib, the active ingredient in Duravu, has been approved in China for kidney cancer but is a new drug entity in the U.S., providing potential advantages in patent protection [44][46] - **Real-World Use**: Duravu is expected to be integrated into existing treatment protocols, potentially allowing for longer intervals between injections compared to current therapies like Eylea and Lucentis [47][49][52] - **Payer Receptiveness**: Payers have shown receptiveness to the idea of a sustained release therapy that reduces treatment burden, which is a significant factor in market adoption [55][56] Financial and Operational Readiness - **Manufacturing Capacity**: EyePoint has established a new manufacturing facility capable of producing hundreds of thousands of inserts annually, with potential expansion to a million inserts [57][59] - **Cash Runway**: The company has sufficient cash to complete pivotal trials and prepare for regulatory approval, with optimism about raising additional funds for commercialization [63][64] Future Outlook - **Data Expectations**: Top-line data from the Lugano trial is expected in mid-2026, with hopes of demonstrating noninferiority or even superiority to Eylea [36][38][62] - **Market Positioning**: The company is optimistic about the potential for rapid uptake of Duravu in the market, especially if pivotal trial results are positive [54][65] Additional Important Information - **Patient Engagement**: Rapid enrollment in trials indicates strong enthusiasm from both doctors and patients for the drug [36] - **Clinical Evidence**: Previous studies suggest that Duravu may provide better visual acuity outcomes compared to existing treatments [41][62]

Company Overview - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts [4] Product Development - EyePoint's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with topline data expected in 2026 [3] - The product has also completed a positive Phase 2 clinical trial in diabetic macular edema (DME), with Phase 3 pivotal planning underway [3] - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of certain regions in Asia [5] Market Context - Wet AMD is the leading cause of vision loss among individuals aged 50 and older in the United States, indicating a significant unmet medical need [3] - Despite existing therapies, patients with wet AMD and DME continue to experience long-term vision loss [3] Corporate Communication - EyePoint Pharmaceuticals will host a conference call and live webcast on August 6, 2025, to report its second quarter 2025 financial results and highlight recent corporate developments [1]

Core Insights - EyePoint Pharmaceuticals, Inc. has granted non-statutory stock options to new employees as inducement awards outside the 2023 Long-Term Incentive Plan, in compliance with NASDAQ Listing Rule 5635(c)(4) [1][2] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing therapeutics for serious retinal diseases [3] - The company's lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 global clinical trials for wet age-related macular degeneration (wet AMD) and has recently completed a Phase 2 trial for diabetic macular edema (DME) [3][5] - EyePoint utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery, which has been safely administered in multiple FDA-approved products [4] Stock Option Details - The company granted stock options to purchase a total of 12,500 shares of common stock to three new employees, with an exercise price of $9.03 per share, the closing price on June 13, 2025 [2] - The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments over the next three years, contingent on continued service [2]

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]