EyePoint Pharmaceuticals Reports Positive Masked Safety Update for Lead Product Candidate EYP-1901 in Ongoing PAVIA and DAVIO 2 Phase 2 Clinical Trials as of September 1, 2023
– Interim analysis of masked data shows EYP-1901 is well tolerated with no reported drug-related ocular or systemic serious adverse events in Phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy –
– Updated interim analysis of masked safety data of Phase 2 DAVIO 2 trial in wet AMD continues to show a positive safety profile with no reported drug-related ocular or systemic SAEs –
– Company remains on-track to report topline data for Phase 2 DAVIO 2 trial in December 2023 and Phase 2 PAVIA trial in 2Q 2024 –
Excerpt from the Press Release:
WATERTOWN, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced positive interim masked safety data for its lead product candidate EYP-1901 from the Company’s ongoing Phase 2 PAVIA trial evaluating EYP-1901 as a potential nine-month treatment for moderately-severe to severe non-proliferative diabetic retinopathy (NPDR) and DAVIO 2 trial as a potential six-month sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD). All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of September 1, 2023.
Approximately 170 patients have received EYP-1901 with a minimum of three months of follow-up post injection from the ongoing Phase 2 PAVIA and DAVIO 2 clinical trials and the completed DAVIO 1 trial with no reported drug-related ocular severe adverse events (SAEs) and no reported drug-related systemic SAEs.
“We remain very encouraged by the positive masked safety results that EYP-1901 has produced to-date in the 17 patients dosed in the Phase 1 DAVIO trial in wet AMD as well as approximately 150 additional patients in our two Phase 2 clinical trials: DAVIO 2 and PAVIA. These results bolster our confidence in EYP-1901 as a potentially paradigm-shifting treatment for patients who would benefit from a safe, sustained therapeutic option for VEGF-mediated diseases,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “In the 77 patients enrolled in the Phase 2 PAVIA trial, the investigators report no drug-related ocular SAEs and no drug-related systemic SAEs, demonstrating EYP-1901’s excellent safety profile in NPDR for the first time. We remain excited about the potential for EYP-1901 in NPDR, a chronic disease where over 90% of patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. We remain on-track to share our topline results from the DAVIO 2 trial in December of this year and from the PAVIA trial in the second quarter of 2024.”
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