Core Viewpoint - EyePoint Pharmaceuticals, Inc. has initiated a public offering of $100 million in common stock to support its clinical development and pipeline initiatives [1][3]. Group 1: Offering Details - The public offering consists of $100 million in shares, with an option for underwriters to purchase an additional $15 million within 30 days [1][2]. - J.P. Morgan, Citigroup, and Guggenheim Securities are the joint book running managers for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance the clinical development of DURAVYU™ for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as to support earlier stage pipeline initiatives and general corporate purposes [3]. Group 3: Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on innovative therapeutics for serious retinal diseases, leveraging its proprietary Durasert E™ technology for sustained intraocular drug delivery [7][8]. - The lead product candidate, DURAVYU™, is currently in Phase 3 clinical trials for wet AMD and Phase 2 trials for DME, with topline data expected in Q1 2025 and 2026 respectively [7][8].

WATERTOWN, Mass., Aug. 27, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, 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 company management will participate at the following upcoming conferences: Morgan Stanley Annual Global Healthcare Conference Forum: 1x1 Investor Meetings Date: Wednesday, September 4, 2024 Baird Global Healthcare Conference Forum: Fireside Chat Date ...

EyePoint Pharmaceuticals (EYPT) came out with a quarterly loss of $0.58 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.61 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -5.45%. A quarter ago, it was expected that this drug delivery technology company would post a loss of $0.34 per share when it actually produced a loss of $0.55, delivering a surprise of -61.76%. Over the last fo ...

Clinical Trials and Efficacy - DURAVYU™ (vorolanib intravitreal insert) is entering Phase 3 clinical trials with a robust dataset and alignment with the FDA on the approval pathway[22] - The Phase 3 trial design includes re-dosing, which aligns with FDA guidelines and clinical use[23] - The next milestone for the DURAVYU™ program is the first Phase 3 trial for wet AMD, expected in the second half of 2024[19] - The Phase 2 DAVIO 2 trial included 161 patients and showed statistically non-inferior best-corrected visual acuity (BCVA) outcomes[32] - DURAVYU demonstrated a statistically non-inferior change in Best-Corrected Visual Acuity (BCVA) compared to Aflibercept, with mean changes of -0.3 letters for 2mg and -0.4 letters for 3mg[38] - The Phase 2 DAVIO 2 trial met all primary and secondary endpoints, confirming a favorable safety profile with no DURAVYU-related serious adverse events[55] - The DAVIO 2 trial showed that eyes treated with DURAVYU maintained stable visual acuity with a mean change in central subfield thickness (CST) of +21.2 µm for DURAVYU 2mg and +10.2 µm for DURAVYU 3mg compared to +10.0 µm for aflibercept[68] - The clinical data supports DURAVYU as a maintenance treatment for Wet AMD, significantly reducing the treatment burden compared to traditional therapies[40][55] Treatment Burden and Patient Compliance - DURAVYU demonstrated a 74% reduction in treatment burden in the DAVIO trial and over 80% reduction in the DAVIO 2 trial, with a favorable safety profile[32] - DURAVYU 2mg and 3mg reduced treatment burden by 89% and 85% respectively compared to the six months prior, with mean injections of 0.55 and 0.73 from week 8 to week 32[40][46] - In comparison to Aflibercept, DURAVYU 2mg and 3mg reduced treatment burden by 83% and 78% respectively, with Aflibercept requiring a mean of 3.28 injections[41] - Nearly two-thirds of eyes treated with DURAVYU were supplement-free up to six months, with 63% of 2mg and 88% of 3mg patients having no or only one supplemental injection[55] - Approximately 50% of DURAVYU-treated eyes were supplement-free up to 12 months, indicating strong anatomical control[72] - The aging population and current treatment protocols indicate a significant need for more durable therapies in wet AMD, with over 80% of retina specialists citing patient noncompliance as a key issue[35] Financial Position and Market Opportunity - The company has approximately $280 million in cash and investments, with no debt on its balance sheet[17] - The company is targeting a multi-billion-dollar market opportunity with its proprietary Durasert E™ drug delivery technology[18] Manufacturing and Regulatory Aspects - The FDA has aligned on a non-inferiority pathway to approval for DURAVYU, supported by the most robust dataset of all long-acting treatments in development[100] - The new manufacturing facility in Northbridge, MA, is built to FDA and EMA standards, enhancing production capabilities for clinical and commercial products[86] - The Phase 3 trials are designed to demonstrate that DURAVYU, administered every six months, achieves similar visual outcomes to aflibercept while reducing treatment burden[76] - The Phase 3 trials will enroll approximately 400 patients per trial, with a focus on previously treated and treatment-naïve patients to enhance trial outcomes[81] Future Plans and Presentations - The company plans to present further detailed results and analyses in upcoming R&D days, highlighting the potential of DURAVYU in the market[61] - Upcoming presentations at major medical conferences will showcase new data from the DAVIO 2 trial, including subgroup analyses and topline results[98]

– Phase 3 trial design for the LUGANO and LUCIA pivotal non-inferiority trials of DURAVYU in wet AMD based on positive EOP2 meeting with FDA; on track for trial initiation in 2H 2024 – – Positive twelve-month safety and efficacy data from Phase 2 DAVIO 2 clinical trial evaluating DURAVYU for the treatment of wet AMD reinforces potential as a sustained six-month maintenance therapy – – Phase 2 trial of DURAVYU in diabetic macular edema (DME) fully enrolled – – EyePoint to webcast its R&D Day event today at 8 ...

Core Insights - EyePoint Pharmaceuticals is focused on developing DURAVYU™ (vorolanib intravitreal insert), an investigational sustained-release therapy aimed at treating VEGF-mediated retinal diseases [1][4][5] - The company announced positive results from the Phase 2 DAVIO 2 trial for wet AMD, highlighting 12-month topline data [1] - Plans for a pivotal non-inferiority Phase 3 trial for DURAVYU™ in wet AMD have been outlined [1] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Watertown, Massachusetts, dedicated to improving the lives of patients with serious retinal diseases [4] - The company utilizes its proprietary Durasert E™ technology for sustained intraocular drug delivery [4] - The lead product candidate, DURAVYU™, combines vorolanib, a selective tyrosine kinase inhibitor, with Durasert E™ [4] Pipeline and Technology - EyePoint's pipeline includes EYP2301, a TIE-2 agonist, and razuprotafib, both formulated with Durasert E™ to enhance treatment outcomes in retinal diseases [4] - The Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four FDA-approved products [4] Upcoming Events - The company will host an R&D Day on June 26, 2024, featuring presentations and discussions with key opinion leaders [6][7] - The agenda will include insights about EyePoint Pharmaceuticals and its ongoing projects [7]

An overview of the science behind DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP1901, an investigational sustained-release therapy with the potential to alter the treatment paradigm for patients suffering from VEGF-mediated retinal diseases A review of the positive Phase 2 DAVIO 2 trial results in wet AMD, including 12-month topline data An update on the pivotal non-inferiority Phase 3 trial plans for DURAVYU™ in wet AMD A KOL roundtable discussion with Drs. Regillo and Modi moderated by Ey ...

Core Points - EyePoint Pharmaceuticals, Inc. announced the granting of non-statutory stock options to new employees as inducement awards outside the Company's 2023 Long-Term Incentive Plan [1] - A total of 44,200 stock options were granted to four new employees, with an exercise price of $12.94 per share, the closing price on May 15, 2024 [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 [2] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for serious retinal diseases [3] - The Company utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3] - The lead product candidate, DURAVYU (EYP-1901), is an investigational treatment for VEGF-mediated retinal diseases [3][4] - Vorolanib, a selective tyrosine kinase inhibitor, is licensed exclusively to EyePoint for ophthalmic diseases outside of certain Asian regions [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ COMMISSION FILE NUMBER 000-51122 EyePoint Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisd ...

– DURAVYU demonstrates stable or improved disease severity with reduced rates of NPDR progression at nine months – – DURAVYU continues to demonstrate favorable safety and tolerability profile with no drug-related serious adverse events – – Conference call to discuss the results to be held at 8:00 a.m. ET – WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with se ...