EyePoint Pharmaceuticals, Inc. announced the Company will highlight clinical and regulatory developments for its lead pipeline program, DURAVYU (vorolanib intravitreal insert), formerly known as EYP-1901, its Durasert E?? sustained drug delivery technology, and early-stage programs during EyePoint's R&D Day on June 26, 2024. R&D Day Highlights: Phase 3 plans for DURAVYUTM in wet AMD, including key design elements of the Phase 3 LUGANO and LUCIA pivotal trials.

Alignment on pathway to approval with U.S. Food and Drug Administration (FDA) based on positive End of Phase 2 eeting for two non-inferiority trials, 6-month redosing of DURAVYU and sham for masking with a one-year endpoint. Each trial is expected to enroll approximately 400 patients with active wet AMD, including previously treated and treatment naïve patients, randomly assigned to either a 2.7mg dose of DURAVYU or an on-label aflibercept control. All patients to receive three monthly loading doses of aflibercept prior to DURAVYU with randomization occurring on Day 1. The LUGANO (US) trial remains on track to initiate in 2H 2024 with LUCIA (US/ex-US) to follow.

Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trialevaluating DURAVYUTM for the treatment of wet AMD. Favorable safety profile ? No DURAVYU elated ocular or systemic SAEs.

Best corrected visual acuity (BCVA) ? Statistically significant visual acuity outcomes with both DURAVYU arms change in visual acuity nearly identical to aflibercept control arm through 12 months after a single injection of DURAVYU. Central Subfield Thickness (CST) ?

Strong anatomical control through 12 months after a single injection of DURAVYU. Supplement Free ? After a single injection of DURAVYU, approximately half of the treated study eyes were anti-VEGF supplement free, while 22% of the eyes in the aflibercept control arm were administered a supplement despite these control eyes receiving mandated bi-monthly injections through 12 months.

The VERONA trial, a Phase 2 trial of DURAVYUTM in diabetic macular edema (DME) patients has completed enrollment with 27 patients assigned to one of two intravitreal doses of DURAVYU or an aflibercept control. To date, DURAVYU is well-tolerated with no reported drug-related ocular or systemic serious adverse events in this trial. DAVIO 2 is a randomized, controlled Phase 2 clinical trial of DURAVYUTM in previously treated patients with wet AMD.

Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of DURAVYU (approximately 2 mg or 3 mg) or an aflibercept control. DURAVYU is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments.

The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the DURAVYU injection. Secondary endpoints include safety, change in CST as measured by optical coherence tomography (OCT), the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. EyePoint anticipates that the first patient in the Phase 3 LUGANO clinical trial of DURAVYU for wet AMD will be dosed in 2H 2024 and the LUCIA trial to follow.

The pivotal trials are expected to enroll approximately 400 patients with active wet AMD each, including both previously treated and treatment naïve patients, randomly assigned to 2.7mg of DURAVYU versus an on-label aflibercept control. DURAVYU is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the LUGANO and LUCIA trials is non-inferiority to the aflibercept control, as measured by change in BCVA twelve-months after two DURAVYU injections that will be administered six-months apart.

Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, reduction in treatment burden and safety.