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

– Continued positive efficacy and durability with stable visual acuity (VA) and optical coherence tomography (OCT) through eight-month follow-up

– 41% of eyes remained rescue free up to nine months after a single dose of EYP-1901

– Positive safety data continued with no dose limiting toxicities, no ocular serious adverse events (SAEs) and no drug-related systemic SAEs observed

– Overall treatment burden reduced by 75% at eight months

– Phase 2 studies for EYP-1901 in wet AMD expected to initiate in Q3 2022 and in diabetic retinopathy in 2H 2022

Excerpt from the Press Release:

WATERTOWN, Mass., Feb. 12, 2022 /PRNewswire/ — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced updated interim data from the “Durasert^® and Vorolanib in Ophthalmology” (DAVIO) Phase 1 clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting wet age-related macular degeneration (wet AMD). These data are being presented today at the Angiogenesis, Exudation, and Degeneration 2022 virtual meeting by Jay S. Duker, M.D., Chief Operating Officer, EyePoint Pharmaceuticals.

“Today’s DAVIO clinical trial update further reinforces the potential for EYP-1901 as a durable anti-VEGF treatment in wet AMD,” said Dr. Duker. “We are extremely pleased with the continued positive safety profile and strong durability results observed after a single injection of EYP-1901. We look forward to initiating a Phase 2 trial of EYP-1901 in the third quarter of this year to potentially alter the treatment paradigm for the millions of patients suffering from wet AMD.”

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.

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