EyePoint Pharmaceuticals (EYPT) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.48. This compares to loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -12.50%. A quarter ago, it was expected that this drug delivery technology company would post a loss of $0.55 per share when it actually produced a loss of $0.58, delivering a surprise of -5.45%.Over the last four ...

WATERTOWN, Mass., Oct. 31, 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 the closing of its previously announced underwritten public offering of 14,636,363 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock, at the publi ...

Core Viewpoint - EyePoint Pharmaceuticals, Inc. has announced a public offering of 12,727,273 shares at a price of $11.00 per share, aiming to raise approximately $140.0 million before expenses [1][2]. Group 1: Offering Details - The offering consists of common stock sold entirely by EyePoint, with the closing expected around October 31, 2024, pending customary conditions [1]. - Underwriters have a 30-day option to purchase an additional 1,909,090 shares at the public offering price [1]. Group 2: Use of Proceeds - Net proceeds from the offering will be utilized to advance clinical development of DURAVYU™ for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as support earlier stage pipeline initiatives and general corporate purposes [2]. 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 [6][7]. - The lead product candidate, DURAVYU™, is currently in Phase 3 trials for wet AMD and Phase 2 trials for DME, with topline data expected in Q1 2025 and 2026 respectively [6][8].

EyePoint Pharmaceuticals (EYPT) shares soared 27.6% in the last trading session to close at $12.12. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 19.1% gain over the past four weeks. Earlier this week, the company announced positive interim 16-week data from the ongoing phase II VERONA study evaluating its lead pipeline candidate, Duravyu, for treating patients with diabetic macular edema. Recently, EyePoint Pharmaceuticals als ...

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]