– 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 8:00 a.m. ET –
WATERTOWN, Mass., June 26, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today 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 today, Wednesday, June 26, 2024, from 8:00 a.m. to 9:30 a.m. ET.
"EyePoint continues to pioneer the development of sustained-release drug delivery treatments for serious retinal diseases with DURAVYU™, a potentially paradigm-shifting, best-in-class treatment for patients suffering from VEGF-mediated retinal diseases," said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. "We have a track record of strong execution, establishing the most robust dataset among sustained delivery TKI programs in wet age-related macular degeneration. We are excited to share the positive twelve-month DAVIO 2 clinical trial data for DURAVYU, as well as our Phase 3 clinical trial plans for wet age-related macular degeneration (wet AMD), with first patient dosing anticipated in the second half of this year. Importantly, our planned Phase 3 design includes redosing, consistent with expected commercial use. We believe DURAVYU and our earlier-stage programs, including EYP-2301, are potentially multi-billion-dollar product opportunities, and we remain laser focused on advancing our mission of improving patient vision with innovative treatment options."
R&D Day will feature commentary from EyePoint's management team as well as key opinion leader (KOL) guest speakers, Carl D. Regillo, M.D., FACS, Professor of Ophthalmology at Thomas Jefferson University, Chief of Retina Service at Wills Eye Hospital, Founder of Wills Eye Clinical Retina Research Unit in Philadelphia, and Partner at Mid Atlantic Retina and Yasha S. Modi, M.D., Associate Professor of Vitreoretinal Surgery, Retinal Disease and Uveitis at New York University and Director of Teleretina.
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 meeting 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 trial evaluating DURAVYUTM for the treatment of wet AMD
- Favorable safety profile – No DURAVYU related 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 ...