WATERTOWN, Mass., Dec. 17, 2025 (GLOBE NEWSWIRE) -- EyePoint, 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 Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 13, 2026 at 7:30 a.m. PT/10:30 a.m. ET. A webcast and subsequent archived replay of the prese ...

Core Insights - EyePoint Pharmaceuticals announced positive recommendations from the independent Data Safety Monitoring Committee (DSMC) for its pivotal Phase 3 trials, LUGANO and LUCIA, evaluating DURAVYU for wet age-related macular degeneration (wet AMD) [1][2][3] - The trials are on track to report topline data in mid-2026, with no changes to the protocol recommended by the DSMC [1][2] - DURAVYU is designed as a sustained-delivery treatment, potentially reducing the treatment burden for patients with wet AMD [5][9] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [11] - The lead product candidate, DURAVYU, combines vorolanib, a selective tyrosine kinase inhibitor, with proprietary Durasert E technology for sustained drug release [11][13] - The company has a history of developing approved drugs and aims to improve patient lives while creating long-term value [12] Clinical Trials - The LUGANO and LUCIA trials are randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials with over 900 patients enrolled [3][9] - The primary endpoint is non-inferiority in best corrected visual acuity (BCVA) change at weeks 52 and 56 compared to baseline [3][9] - Secondary endpoints include safety, treatment burden reduction, and anatomical results measured by optical coherence tomography (OCT) [3][9] Treatment Context - Wet AMD is a leading cause of vision loss in individuals over fifty, requiring continuous treatment to maintain visual function [4] - Current standard-of-care treatments are administered on average every two months, posing a significant burden on patients and healthcare systems [4] - DURAVYU aims to address these challenges by providing a sustained-release option that could reduce the frequency of treatments [5][9] Product Details - DURAVYU is a solid bioerodible insert designed to release a constant therapeutic dose for at least six months [5][6] - Vorolanib, the active ingredient, has shown no ocular safety signals in previous trials and targets multiple pathways involved in retinal diseases [7][8] - The product is positioned to potentially offer a flexible dosing regimen for physicians treating wet AMD [9][10]

Summary of EyePoint Pharmaceuticals Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Focus**: Phase 3 development in sustained drug delivery for wet age-related macular degeneration (AMD) and diabetic macular edema (DME) [1][2] Key Points Industry and Market Position - EyePoint is a leader in sustained drug delivery to the back of the eye, with a focus on wet AMD and DME [2] - The company has a strong balance sheet with approximately $350 million in cash, providing a runway into Q4 2027 [3] Clinical Trials and Pipeline - **Wet AMD Trials**: Two phase 3 trials (LUGANO and LUCIA) are fully enrolled, with top-line data expected mid-2026 [10][22] - **DME Trials**: First patients to be dosed in Q1 2026, with simultaneous readouts expected in Q4 2027 [3][19] - **EYP2301**: A pipeline asset in preclinical stage [3] Technology and Drug Delivery - **DuraCert Technology**: Proven in four FDA-approved products, with a new delivery system (Duravyu) consisting of 94% drug and 6% matrix [4][5] - **Vorolanib**: A multi-mechanism action (MOA) drug that blocks VEGF receptors and inflammation through JAK1, showing sustained drug levels for at least six months [4][6][8] Efficacy and Safety - Previous trials (one phase 1 and three phase 2) demonstrated excellent efficacy and safety, with no ocular or systemic serious adverse events (SAEs) reported [5][6] - Vorolanib showed over 50% reduction in IL-6 activity, indicating potential for better outcomes in DME and wet AMD [9][16] Competitive Landscape - EyePoint's approach may capture significant market share if non-inferiority to existing treatments (Eylea and Lucentis) is demonstrated, with potential for better visual outcomes and reduced treatment burden [26][27] - Other companies, such as Kodiak Sciences and Genentech, are also exploring IL-6 blockage, indicating a competitive environment [16] Commercial Strategy - The company is focused on commercial scale-up and success, with a new facility in Northbridge, Massachusetts, capable of producing hundreds of thousands of inserts annually [24] - Physician enthusiasm for the treatment is high, with expectations that a successful trial could shift retinal practice towards EyePoint's TKI approach [25][26] Regulatory Considerations - The FDA has provided clear guidelines for non-inferiority trials, requiring on-label controls for both wet AMD and DME [34] - EyePoint plans to leverage safety data from wet AMD trials to inform DME trials, potentially reducing the number of patients needed for safety assessments [21][22] Future Outlook - The company is positioned to be first in class and best in class in the two largest retinal indications, with robust phase 1 and phase 2 efficacy and safety data [22] - Full enrollment for DME trials is expected in the second half of next year, with a focus on achieving better visual acuity and reduced treatment burden [22][23] Additional Insights - The company emphasizes the importance of sustained release options for chronic diseases, which may improve patient compliance and outcomes [29] - The potential for neuroprotective and antifibrotic effects from vorolanib could further differentiate EyePoint's offerings in the market [27][28]

Summary of EyePoint Pharmaceuticals FY Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Mission**: To improve patients' lives through enhanced treatment of retinal diseases, focusing on drug delivery systems [6][5][4] Key Trials and Developments - **Pivotal Trials**: - Two pivotal trials for wet age-related macular degeneration (AMD): Lugano Trial and Lugia Trial, both fully enrolled with over 400 patients each [6][7] - Expected readout for Lugano Trial in mid-2026 and Lugia Trial shortly thereafter [6] - Phase three trials for diabetic macular edema (DME) named COMO and COPRI, with patient dosing starting in Q1 2026 [7] - **Drug Mechanism**: Vorolanib, the drug in focus, exhibits both anti-VEGF and anti-inflammatory effects by blocking the JAK1 receptor, which is significant for conditions like diabetic macular edema and wet AMD [9] Enrollment and Study Design - **Rapid Enrollment**: The rapid enrollment in the wet AMD trials was attributed to strong phase two data and the patient-centric design of the studies [11][10] - **Patient Population**: The phase three study includes both previously treated and naive patients, with expectations of better outcomes in naive patients [14][13] Safety and Efficacy Expectations - **Safety Profile**: The safety results so far are consistent with prior trials, with no vision loss reported due to the drug insert [21][23] - **Efficacy Goals**: The aim is to be statistically non-inferior to Eylea, with hopes of achieving statistical superiority [20][19] Competitive Landscape - **Market Position**: EyePoint aims to differentiate itself from competitors like Vabysmo and Eylea by offering a different mechanism of action and a six-month dosing schedule [36][37] - **First-to-Market Advantage**: If approved, EyePoint will be the first to market with its sustained-release product, which is expected to be advantageous [38] Market Potential - **DME Market Size**: The DME market is approximately $3 billion in the U.S., representing about 35-40% of the overall market for retinal diseases [49][50] Regulatory and Global Strategy - **Regulatory Readiness**: EyePoint is preparing for a pre-approval inspection by the FDA and has a clear plan for NDA submission based on the results of the ongoing trials [33][31] - **Ex-U.S. Strategy**: The company plans to include European sites in its studies and is preparing for potential launch outside the U.S., with a focus on finding a global partner at the right time [50][51] Conclusion EyePoint Pharmaceuticals is positioned at a pivotal moment with multiple ongoing trials and a strong focus on innovative drug delivery for retinal diseases. The company is optimistic about its upcoming trial results and the potential market impact of its products.

Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and discuss recent corporate developments during a conference call on November 5, 2025 [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company's lead product candidate, DURAVYU, is an investigational sustained delivery treatment for serious retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with next-generation bioerodible Durasert E technology [3] - DURAVYU is currently undergoing evaluation in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with data expected in mid-2026, and the first patient dosing in trials for diabetic macular edema (DME) anticipated in Q1 2026 [3] Product Information - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU has received conditional acceptance from the FDA as the proprietary name for EYP-1901 (vorolanib intravitreal insert) but is not yet authorized for sale in any country [6] Commitment to Community - The company aims to partner with the retina community to enhance patient lives while creating long-term value, having developed four approved drugs over three decades and treated tens of thousands of patients [4]

Core Insights - EyePoint Pharmaceuticals is advancing DURAVYU (vorolanib intravitreal insert) into Phase 3 trials for diabetic macular edema (DME), with first patient dosing expected in Q1 2026 [1][14] - New preclinical data indicates that vorolanib inhibits both VEGF-mediated vascular permeability and IL-6 mediated inflammation, which are significant factors in wet AMD and DME [1][4] - DURAVYU is positioned as a potential multi-mechanism treatment option, addressing both inflammation and vascular leakage, which are critical in managing DME [2][5] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases [15] - The lead product candidate, DURAVYU, utilizes next-generation Durasert E technology for sustained drug delivery [10][15] - Vorolanib, the active ingredient in DURAVYU, is a selective tyrosine kinase inhibitor targeting both VEGF and IL-6 pathways [11][12] Clinical Development - The Phase 3 program for DME consists of two identical non-inferiority trials, enrolling approximately 240 patients each, comparing DURAVYU to aflibercept [6][12] - The primary endpoint of the trials is the change in best corrected visual acuity (BCVA) at weeks 52 and 56 [6] - Previous Phase 2 trials demonstrated significant treatment burden reduction, with approximately 88% fewer injections needed after six months [12] Market Need - There is a significant unmet need for effective treatments for DME, as up to two-thirds of patients remain active despite anti-VEGF therapies [5][8] - The multifactorial nature of DME necessitates treatment options that address both VEGF and inflammatory pathways [5][8] - DME is a leading cause of vision loss in diabetic patients, affecting approximately 28 million people globally [9] Future Outlook - The retinal community is optimistic about DURAVYU's potential to improve patient outcomes, particularly given its favorable safety profile and dosing intervals compared to existing therapies [8][14] - EyePoint plans to present preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025 [8]

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]