RegulatoryCompany release

Opus Genetics wins FDA approval for RYZUMVI in presbyopia and clears RDH12 IND

🇺🇸 Opus Genetics, Inc. (IRD) · Tue 10 Nov 2026

The US company also reports full enrolment in its OPGx-LCA5 Phase 3 trial and cash of $89.0 million, which it says funds operations into 2029.

Opus Genetics reported third-quarter 2026 results and a corporate update on 10 November, led by an FDA approval. The agency approved the company's supplemental new drug application for phentolamine ophthalmic solution 0.75%, sold as RYZUMVI, to treat presbyopia in adults.

The approval triggers a milestone payment from Viatris. The summary of the update does not give the amount or the timing of the payment.

On the gene therapy side, the FDA cleared the investigational new drug application for OPGx-RDH12, a candidate for Leber congenital amaurosis associated with RDH12 mutations. Opus has also fully enrolled its Phase 3 trial of OPGx-LCA5.

Dosing has been completed in Cohort 2 of the OPGx-BEST1 programme, with data expected in the first quarter of 2027. Opus reported $89.0 million in cash and said it expects this to fund operations into 2029.

What it means for your team

  • Regulatory teams tracking ophthalmology should note the RYZUMVI presbyopia indication for adults now sits within the FDA-approved label for phentolamine 0.75%.
  • The RDH12 IND clearance allows clinical work to begin in another inherited retinal disease, adding to the competitive pipeline in ocular gene therapy.
  • Market-access and pipeline watchers should look for the OPGx-BEST1 Cohort 2 data in Q1 2027 as the next scheduled clinical readout.

Company's press release (SEC filing): Opus Genetics, Inc. ↗

Article written by VigiEye from the official source (Opus Genetics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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