EyePoint Pharmaceuticals Advances DURAVYU Phase 3 Trials for Wet AMD After Positive Safety Review

Reuters
2025.11.19 12:05
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EyePoint Pharmaceuticals announced a positive safety review from the DSMC for its Phase 3 trials of DURAVYU for wet AMD. No changes to trial protocols are needed, and no new safety signals were found. Initial dosing is complete, with 25% of patients receiving a second dose. Topline data for the LUGANO trial is expected mid-2026, followed by the LUCIA trial results.

EyePoint Pharmaceuticals Inc. announced that the independent Data Safety Monitoring Committee (DSMC) has provided a positive recommendation following its second scheduled review of the Company’s ongoing pivotal Phase 3 trials-LUGANO and LUCIA-evaluating DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD). The DSMC advised that no changes to the trial protocols are necessary and found no new safety signals, consistent with previous clinical trials for DURAVYU. As of the September 29, 2025 data cutoff, all patients had received their initial dosing, and approximately 25% had received their second dose. EyePoint Pharmaceuticals remains on track to report topline 56-week data for the LUGANO trial in mid-2026, with results from the LUCIA trial to follow. No efficacy results have been presented yet. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. EyePoint Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-286961), on November 19, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here