EyePoint Pharmaceuticals Announces Updated Positive Interim Safety and Efficacy Data from Ongoing Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD
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"Today's DAVIO clinical trial update further reinforces the potential for EYP-1901 as a durable anti-VEGF treatment in wet AMD," said
The interim eight-month follow-up data presented from the Phase 1 DAVIO clinical trial continue to show no reports of ocular serious adverse events (SAEs) or drug-related systemic SAEs. There have been no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, or posterior segment inflammation. These data also show that 41% of eyes did not require any supplemental anti-VEGF injections up to nine months following a single dose of EYP-1901. Additionally, updated data from the eight-month follow-up confirm stable best corrected visual acuity (BCVA) (-3.0 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (+13 μm), and a clinically significant 75% reduction in treatment burden.
The Phase 1 DAVIO trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD. EYP-1901 is a sustained delivery anti-VEGF investigational treatment that utilizes a bioerodible formulation of EyePoint's Durasert® drug delivery technology that has been utilized in four FDA-approved products, including EyePoint's YUTIQ® for chronic non-infectious uveitis affecting the posterior segment of the eye.
EyePoint plans to initiate a Phase 2 trial of EYP-1901 in wet AMD in the third quarter of this year, informed by a positive Type C meeting with
EYP-1901 is being developed as an investigational six-month treatment, initially in wet AMD, combining a bioerodible formulation of EyePoint's proprietary Durasert® sustained delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive interim eight-month safety data from the ongoing Phase 1 DAVIO clinical trial of EYP-1901 show no reports of ocular or drug-related systemic SAEs and no dose limiting toxicities. Positive efficacy data from the ongoing DAVIO trial reflect positive efficacy and durability with stable
About Wet AMD
Age-related macular degeneration (AMD) impacts as many as 11 million Americans. About 15% of those affected have neovascular or wet AMD - the hallmark of which is fluid and bleeding in the center of the retina, which may lead to irreversible vision loss. The majority of patients with wet AMD require intravitreal injections every month or two to control the disease. This intense treatment regimen represents an ongoing challenge for patients, caregivers, and physicians.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the potential for EYP-1901 as a six-month sustained delivery intravitreal anti-VEGF treatment targeting wet AMD, with potential in DR and RVO; our expectations regarding the timing and outcome of our Phase 1 DAVIO clinical trial for EYP-1901 for the potential treatment of wet AMD; our expectations regarding the timing and clinical development of our product candidates, including EYP-1901 and YUTIQ 50; and the potential advantages of our product candidates for the treatment of eye diseases; and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint's actual results to be materially different than those expressed in or implied by EyePoint's forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel six-month treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the
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