---
title: "Opus Genetics posts press release on FDA alignment for OPGx-LCA5 Phase 3 trial design"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/291793057.md"
description: "Opus Genetics announced FDA alignment on the Phase 3 trial design for OPGx-LCA5, a treatment for LCA5-associated inherited retinal disease. The FDA indicated that a Biologics License Application (BLA) could be filed based on six-month efficacy data, with twelve-month durability data submitted during review. The Phase 3 trial will target eight participants receiving bilateral treatment, with dosing scheduled for the fourth quarter of 2026."
datetime: "2026-07-06T11:02:43.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/291793057.md)
  - [en](https://longbridge.com/en/news/291793057.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/291793057.md)
generator: "portal-rs"
---

# Opus Genetics posts press release on FDA alignment for OPGx-LCA5 Phase 3 trial design

-   (here) posted FDA alignment on a Phase 3 registrational trial for OPGx-LCA5 in LCA5-associated inherited retinal disease. \* FDA signaled a BLA could be filed on 6-month efficacy data, with 12-month durability data submitted during review. \* Phase 3 targets eight participants with both eyes treated; dosing planned for 4Q 2026. 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. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607060700PRIMZONEFULLFEED9757075) on July 06, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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