EYEPOINT PHARMACEUTICALS, INC. EyePoint Pharmaceuticals, Inc. provided key 2023 clinical timelines for its lead product candidate, EYP-1901. EYP-1901 is an investigational sustained delivery product for serious retinal diseases that uses a bioerodible Durasert® micro insert of vorolanib, a selective and patented tyrosine kinase inhibitor (TKI). EYP-1901 represents a potential new mechanism of action and treatment paradigm for retinal diseases by acting as an intracellular vascular endothelial growth factor (VEGF) receptor blocker, which could provide added benefits beyond the traditional large molecule anti-VEGFs.
EYP-1901 is currently in Phase 2 clinical trials for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR). Anticipated 2023 Milestones: EYP-1901: EYP-1901 is an investigational product and lead pipeline program deploying a bioerodible Durasert insert containing vorolanib, a selective and patented TKI that brings a new mechanism of action that potentially has clinical benefits beyond current large molecule anti-VEGFs. With the combination of vorolanib and proprietary bioerodible six to nine month Durasert, EYP-1901 can potentially change the current treatment paradigm for serious eye diseases.
Positive twelve-month safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and macular thickness on OCT. Further, 53% and 35% of eyes did not require supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Enrollment in the Phase 2 clinical trials for EYP-1901 in wet AMD and NPDR is ongoing and remains on track.
Topline interim six-month data from the Phase 2 DAVIO 2 clinical trial for wet AMD is anticipated in fourth quarter 2023. Complete enrollment in the Phase 2 PAVIA trial for NPDR is expected by fourth quarter 2023. Expect to initiate a randomized, controlled Phase 2 clinical trial in diabetic macular edema (DME) in fourth quarter 2023.
YUTIQ: YUTIQ is approved for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and the Company is commercializing it directly in the U.S. YUTIQ is currently being commercially launched in China by EyePoint's partner OcuMension Therapeutics. There are currently two Phase 4 trials underway for YUTIQ: The CALM study, a Phase 4 multi-center retrospective registry study, in collaboration with the Cleveland Clinic, to collect real-world data on the implant. Efficacy outcomes on individual and combined patient cohorts are planned for presentation during medical conferences in 2023.
The SYNCHRONICITY study is a prospective, open label study to assess safety and efficacy of YUTIQ in the treatment of chronic, non-infectious posterior segment uveitis and intraocular inflammation. This is a two-year follow up study with an interim six-month efficacy readout anticipated in second half 2023. Pipeline Expansion: EyePoint continues to evaluate molecules for potential use in its Durasert technology for future growth.
