IRD Opus Genetics

Viatris Receives FDA Approval for RYZUMVI (phentolamine ophthalmic solution 0.75%) for Presbyopia

The FDA approved RYZUMVI for the treatment of presbyopia in adults, expanding its existing indication for pharmacologically-induced mydriasis. This is the first and only FDA-approved ophthalmic solution for presbyopia in this formulation. Viatris is exploring a U.S. commercialization partner for the new indication under its existing global licensing agreement with Opus Genetics.

Opus Genetics presents positive OPGx-LCA5 and OPGx-BEST1 data at Retina in Rio 2026

Opus Genetics presented positive interim Phase 1/2/3 data for OPGx-LCA5 showing sustained visual acuity and light sensitivity improvements through 24 months in adults and 6 months in pediatrics. The company also announced Phase 3 dosing for OPGx-LCA5 is expected in Q4 2026. Positive low-dose Cohort 1 data for OPGx-BEST1 was also shared.

OPGx-BEST1 · NCT07185256 registry update

countries: {'total_sites': 4, 'us_sites': 4} → {'total_sites': 5, 'us_sites': 5}

Opus Genetics OPGx-BEST1 Phase 1/2 Cohort 1 3-month topline

Low-dose Cohort 1 data show 75% of evaluable patients met the FDA-aligned microperimetry endpoint and 80% had structural improvement. Cohort 2 is over-enrolled; 6-month Cohort 1 and 3-month Cohort 2 data are now expected in Q2 2027, with pivotal trial dosing slated to begin in 2027.

Opus Genetics aligns with FDA on Phase 3 design for OPGx-LCA5

FDA Type B RDEP meeting minutes confirm registrational Phase 3 trial design with 8 participants and 6-month primary endpoint. Company may submit BLA based on 6-month efficacy data, with 12-month durability data provided during review. Phase 3 dosing expected to begin Q4 2026.

Opus Genetics R&D Science Forum June 16, 2026

Opus Genetics will host an R&D Science Forum on June 16, 2026, to present updates on its inherited retinal disease gene therapy pipeline. The event will cover multiple programs including LCA5, BEST1, RDH12, MERTK, and RHO, with presentations from company leadership and key opinion leaders.

Opus Genetics: FDA sets Oct 17 2026 PDUFA for Phentolamine 0.75% presbyopia sNDA

FDA accepted the sNDA for Phentolamine Ophthalmic Solution 0.75% in presbyopia and assigned a PDUFA action date of October 17, 2026. The filing acceptance establishes a defined regulatory timeline for the small-molecule asset. No other regulatory milestones for the gene-therapy pipeline are altered by this document.

Opus Genetics: OPGx-BEST1 Phase 1/2 initial data expected Q1 2026

The company announced that the first participant in the OPGx-BEST1 Phase 1/2 trial was dosed in Q4 2025 and that an IDMC safety review of the one-month sentinel data recommended continued enrollment without modification. Initial data from the trial is now guided for Q1 2026, with 3-month results from the full Cohort 1 expected in mid-2026.

Opus Genetics submits sNDA for phentolamine 0.75% in presbyopia

Opus Genetics submitted a supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA is expected to issue a regulatory decision by the end of 2026. This submission adds a potential new commercial indication to the company’s partnered small-molecule program.

Opus Genetics: Viatris files sNDA for Phentolamine in presbyopia

Viatris submitted an sNDA to FDA for Phentolamine Ophthalmic Solution 0.75% in presbyopia on 17 Dec 2025. The filing rests on positive VEGA-3 Phase 3 data confirming efficacy, safety, and durability seen in VEGA-2. No PDUFA date or acceptance decision has been announced.

Opus Genetics: FDA RMAT meeting completed for OPGx-LCA5

The document states that a Type B RMAT meeting with the FDA has been successfully completed, providing the potential for an accelerated regulatory pathway to approval of OPGx-LCA5. The company plans to advance the ongoing trial into a Phase 3 portion with an adaptive design and anticipates dosing in the second half of 2026 with topline data expected approximately one year later.

Opus Genetics reports positive pediatric data from OPGx-LCA5 Phase 1/2 trial

The press release announces positive three-month pediatric data from the ongoing Phase 1/2 trial of OPGx-LCA5, showing clinically meaningful improvements in visual acuity, retinal sensitivity, and mobility testing in teenagers with severe baseline vision loss. Durable responses out to 18 months in adults were also confirmed. The company expects an FDA meeting in Q4 2025 to discuss next steps for the LCA5 program.