Core Insights - EyePoint Pharmaceuticals, Inc. is focused on developing innovative therapeutics for serious retinal diseases, with a commitment to improving patient lives [2][3] Company Overview - EyePoint is a clinical-stage biopharmaceutical company utilizing its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery [2] - The lead product candidate, DURAVYU, is an investigational treatment for VEGF-mediated retinal diseases, currently in Phase 3 trials for wet age-related macular degeneration (wet AMD) and has completed Phase 2 trials for diabetic macular edema (DME) [2][4] - The company anticipates discussions with regulatory agencies in Q2 2025 regarding pivotal program plans based on positive Phase 2 results from the VERONA trial in DME [2] Pipeline Programs - Additional pipeline programs include EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E to potentially enhance outcomes in serious retinal diseases [3] - Durasert technology has been safely administered to thousands of patient eyes across four FDA-approved products for various disease indications [3] Upcoming Investor Conferences - EyePoint management will participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, and the Barclays 27th Annual Global Healthcare Conference on March 12, 2025 [5]

Core Viewpoint - EyePoint Pharmaceuticals, Inc. is set to report its fourth quarter and full-year 2024 financial results on March 5, 2025, during a conference call and live webcast [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases [3] - The company utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3] - EyePoint's 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 Development - The pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E™ to potentially enhance outcomes in serious retinal diseases [4] - DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901, although it has not yet received FDA approval [5] - Positive Phase 2 results from the VERONA clinical trial in DME have led the company to plan meetings with regulatory agencies in Q2 2025 to discuss pivotal program plans [3]

Core Insights - EyePoint Pharmaceuticals is set to present an update on its DURAVYU™ Phase 3 pivotal program for wet age-related macular degeneration (wet AMD) and additional analyses from the Phase 2 VERONA trial for diabetic macular edema (DME) at the TD Cowen 45th Annual Health Care Conference on March 4, 2025 [1][6] Company Overview - EyePoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3][4] - The lead product candidate, DURAVYU™, is an investigational treatment for VEGF-mediated retinal diseases, combining vorolanib, a selective tyrosine kinase inhibitor, with Durasert E™ [3][5] - DURAVYU™ is currently in Phase 3 global pivotal trials for wet AMD, which is the leading cause of vision loss in individuals aged 50 and older in the U.S., and has recently completed a Phase 2 trial for DME [3][5] Pipeline Programs - EyePoint'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] - The Durasert drug delivery technology has been safely administered to thousands of patients across four FDA-approved products for various disease indications [4] Regulatory Status - Vorolanib is exclusively licensed to EyePoint for the localized treatment of all ophthalmic diseases outside of specific regions in Asia [5] - DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901, but it remains an investigational product and has not yet received FDA approval [5]

Summary of EyePoint Pharmaceuticals (EYPT) Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals - **Focus**: Leader in sustained release drug delivery for retinal diseases, specifically targeting diabetic macular edema (DME) and wet age-related macular degeneration (AMD) with its lead product DuraView, which contains the drug virolinib [5][6] Key Points from the Conference Call Industry Context - **Market Size**: The global market for diabetic macular edema (DME) is projected to approach $4 billion within five years, with an estimated 50 million diabetics in the U.S. by then, and one in four expected to develop DME [14][15] - **Unmet Need**: There is a significant unmet need for durable treatments in DME, as many patients do not adhere to treatment schedules, leading to severe visual loss [15] Product Development and Trials - **DuraView**: - A sustained release drug delivery system that provides continuous dosing for at least six months [8][12] - Currently undergoing two global Phase III non-inferiority pivotal trials in wet AMD, with enrollment expected to complete in the second half of the year [6][34] - **VIRONA Trial**: - A Phase II clinical trial for DME showing promising results, including a best corrected visual acuity (BCVA) improvement of 7.1 letters and a significant central subfield thickness (CST) improvement of 76 microns [20][21] - 73% of patients in the DuraView 2.7 mg arm were supplement-free at six months compared to 50% in the control group [26][21] Safety and Efficacy - **Safety Profile**: No ocular or systemic serious adverse events (SAEs) reported in the trial, indicating a favorable safety profile for DuraView [21][30] - **Efficacy**: - DuraView demonstrated immediate bioavailability and sustained delivery, with significant improvements in both vision and anatomy observed as early as week four [31][32] - The trial's unique supplemental criteria contributed to the majority of supplements, but the overall results remained strong [20][19] Future Plans - **Phase III Protocol**: - Planning to discuss the proposed Phase III clinical protocol with regulatory agencies, aiming for a non-inferiority design [32][33] - Anticipating initiation of the pivotal program by the end of 2025, leveraging experience from ongoing trials to enhance efficiency [33][39] - **Manufacturing Facility**: A new 41,000 square foot manufacturing facility opened in October 2024, expected to supply DuraView for the DME Phase III trial and future commercial needs [37][38] Market Positioning - **Competitive Advantage**: DuraView's sustained release mechanism and favorable safety profile position it well against competitors, especially in a market where patients often struggle with treatment adherence [63][87] - **Regulatory Outlook**: Optimism regarding the potential for a single Phase III trial based on recent regulatory precedents [73] Analyst Questions and Responses - **Outlier Impact**: Discussion on how a single outlier patient affected the results, with confidence that larger trials will mitigate such effects [46][48] - **Market Acceptance**: The potential for DuraView to be widely accepted in the market due to its dosing schedule and safety profile, regardless of competing products [63][62] Conclusion EyePoint Pharmaceuticals is advancing its DuraView product through promising clinical trials, addressing a significant unmet need in the DME market. The company is well-positioned for future growth with a strong safety profile, innovative drug delivery technology, and a strategic plan for regulatory engagement and market entry.

Core Insights - EyePoint Pharmaceuticals announced positive six-month results from the Phase 2 VERONA clinical trial for DURAVYU, achieving its primary endpoint of extended time to first supplemental injection compared to aflibercept control [1][3] - DURAVYU 2.7mg showed a significant improvement in best corrected visual acuity (BCVA) with a gain of +7.1 letters and a reduction in central subfield thickness (CST) by 76 microns, alongside a two-thirds reduction in treatment burden [1][2][3] - The safety profile of DURAVYU remains favorable, with no ocular or systemic serious adverse events reported [1][3] Company Overview - EyePoint Pharmaceuticals is focused on developing innovative therapeutics for serious retinal diseases, utilizing its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [11] - The company plans to initiate a Phase 3 non-inferiority pivotal program for DURAVYU in diabetic macular edema (DME) by the end of 2025, following positive Phase 2 results [1][10] Clinical Trial Details - The Phase 2 VERONA trial involved 27 patients and compared two doses of DURAVYU (1.34mg and 2.7mg) against aflibercept control, with the primary endpoint being the time to first supplemental injection over 24 weeks [4] - Key secondary endpoints included changes in BCVA, CST, and diabetic retinopathy severity scale (DRSS) [4] Market Context - DME is a leading cause of vision loss among working-age adults, with a significant need for more durable treatment options as the prevalence of diabetes increases [6][4] - The number of diabetic retinopathy patients is projected to reach 16 million by 2050, highlighting the growing market for effective treatments [4] Future Outlook - EyePoint anticipates presenting interim data at an upcoming medical meeting and is preparing for discussions with the FDA regarding the Phase 3 trial initiation [5][2] - The company is also conducting ongoing pivotal trials in wet age-related macular degeneration (wet AMD), with results expected in 2026 [10][11]

- Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control – - DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds – Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs – – Phase 3 non-inferiority pivotal program initiation a ...

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Core Insights - EyePoint Pharmaceuticals, Inc. is focused on developing innovative therapeutics for serious retinal diseases and will have its CEO participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 6, 2025 [1][2] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company that utilizes proprietary bioerodible Durasert E technology for sustained intraocular drug delivery [3] - The lead product candidate, DURAVYU (formerly EYP-1901), is in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and Phase 2 trials for diabetic macular edema (DME) [3][4] - Full topline data from the Phase 2 trial in DME is expected in Q1 2025, with topline data from Phase 3 trials in wet AMD anticipated in 2026 [3] Product Pipeline - Pipeline includes EYP-2301, a TIE-2 agonist, and razuprotafib, both formulated in Durasert E to potentially enhance outcomes in serious retinal diseases [4] - The Durasert drug delivery technology has been safely used in thousands of patient eyes across four FDA-approved products [4] Licensing and Regulatory Status - Vorolanib, a key component of DURAVYU, is exclusively licensed to EyePoint for localized treatment of ophthalmic diseases outside of certain Asian markets [5] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901, but it remains an investigational product and has not yet received FDA approval [5]

Core Insights - EyePoint Pharmaceuticals is advancing its lead product candidate, DURAVYU, with enrollment in Phase 3 clinical trials for wet AMD exceeding expectations, particularly with the LUGANO trial having one-third of its planned patients enrolled and the LUCIA trial ahead of schedule [1][2][3] - Full data from the Phase 2 VERONA clinical trial for diabetic macular edema (DME) is anticipated in the first quarter of 2025, with positive interim results already reported [1][8] - The company has appointed Dr. Reginald J. Sanders, a renowned retina specialist, to its Board of Directors, enhancing its leadership team [1][10] - EyePoint has a strong financial position with approximately $370 million in cash and investments as of December 31, 2024, providing a cash runway into 2027 [1][10] Clinical Trials and Data - The global Phase 3 trials, LUGANO and LUCIA, are designed to evaluate the efficacy, durability, and safety of DURAVYU, with topline data expected in 2026 [3][11] - DURAVYU's Phase 2 clinical trial (DAVIO 2) demonstrated a treatment burden reduction of approximately 88% six months post-treatment, with over 80% of patients being supplement-free or requiring only one supplemental anti-VEGF injection [7][10] - Interim data from the Phase 2 VERONA trial showed that DURAVYU 2.7mg significantly improved patients with active DME, with a central subfield thickness (CST) improvement of 68.1 microns and a best-corrected visual acuity (BCVA) gain of +8.9 letters compared to baseline [3][8] Manufacturing and Infrastructure - EyePoint opened a new 40,000 square-foot manufacturing facility in Northbridge, MA, in fall 2024, which is designed to meet FDA and EMA standards and support global manufacturing for DURAVYU [2][10] - The facility enhances EyePoint's manufacturing capabilities and is strategically positioned to support the company's growth and pipeline expansion [10] Future Milestones - EyePoint will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, to provide updates on clinical and regulatory progress [1][10] - The company is preparing for interactions with the FDA and EMA regarding the Phase 3 plans following the full topline data from the VERONA trial [10][11]

Company Announcement - EyePoint Pharmaceuticals appoints Dr Reginald J Sanders to its Board of Directors [1] - Dr Sanders is a distinguished leader in ophthalmology with extensive experience in retina research and business development [2] - Dr Sanders has served as President of the American Society of Retina Specialists and is a board member of Prism Vision Group [2] - Dr Sanders has over 50 publications and has been a principal investigator for landmark treatments like Lucentis [2] - Dr Sanders has received numerous honors including induction into the Retina Hall of Fame and the Packo Service Award [3] Clinical Development - EyePoint's lead product candidate DURAVYU is in Phase 3 global pivotal trials for wet AMD and Phase 2 trials for diabetic macular edema [4] - Topline data from the Phase 2 trial in diabetic macular edema is expected in Q1 2025 [4] - Topline data from both Phase 3 pivotal trials in wet AMD is expected in 2026 [4] - EyePoint's pipeline includes EYP-2301 a TIE-2 agonist formulated in Durasert E to potentially improve outcomes in serious retinal diseases [5] Technology and Partnerships - EyePoint leverages its proprietary bioerodible Durasert E technology for sustained intraocular drug delivery [4] - Vorolanib used in DURAVYU is licensed exclusively by Equinox Sciences for ophthalmic diseases outside of China Macao Hong Kong and Taiwan [6] - DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901 [6]