sNDA for phentolamine ophthalmic solution 0.75% from Opus Genetics accepted for review by FDA

The US Food and Drug Administration (FDA) has accepted for a review a supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% (Ryzumvi) for the treatment of presbyopia from Opus Genetics.

The FDA has assigned a PDUFA goal date of October 17, 2026.¹

Ryzumvi is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics and improve visual acuity through a sympatholytic mechanism of action that avoids engaging the ciliary muscle. It is currently approved for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents. Opus hopes to expand the label to include presbyopia.

George Magrath, MD, CEO of Opus Genetics, commented on the FDA action, saying, “The FDA’s acceptance of our sNDA marks an important milestone in expanding the potential use of phentolamine ophthalmic solution as a differentiated approach to managing presbyopia. Phentolamine is targeted to improve near vision while preserving distance vision, with a sustained effect on pupil diameter of up to 20 hours. Our team continues to make tremendous progress in advancing our mission to bring meaningful new ophthalmic treatment options to patients.”

The sNDA sent to the FDA is supported by data from VEGA-2 and VEGA-3.

According to the company, the VEGA-3 trial (NCT06542497) met its primary endpoint of proportion of participants achieving a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) improvement in binocular DCNVA and with less than 5 letters of loss in binocular BCDVA from baseline at 12 hours post-dose on day 8, as compared to placebo. Results showed a statistically significant number of participants (27.2%) treated with phentolamine ophthalmic solution 0.75% met this endpoint, compared to 11.5% of patients on placebo (p<0.0001).²

Additionally, 20.6% of patients in the phentolamine arm achieved ≥15-letter ETDRS (≥3-line) gain in DCNVA at 1-hour post-dose on day 1 compared to 6.1% of those receiving placebo (p=0.0002). No evidence of tachyphylaxis was observed after 6 weeks compared to the primary endpoint at day 8, 12 hours post-dose.²

Most recently, Opus Genetics launched its clinical trial evaluating OPGx-MERTK gene therapy for MERTK-related retinitis pigmentosa (RP). The trial is funded through Abu Dhabi’s Healthcare Research and Innovation Fund.³

OPGx-MERTK is an investigational adeno-associated virus (AAV)-based gene therapy designed to deliver a functional copy of the MERTK gene to retinal cells.

References:

1. Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia. Published February 25, 2026. Accessed February 25, 2026. https://www.globenewswire.com/news-release/2026/02/25/3244435/0/en/Opus-Genetics-Announces-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-Phentolamine-Ophthalmic-Solution-0-75-for-the-Treatment-of-Presbyopia.html

2. Harp MD. Opus Genetics reports positive phase 3 results for phentolamine ophthalmic solution 0.75%. Published June 26, 2025. Accessed February 25, 2026. https://www.ophthalmologytimes.com/view/opus-genetics-reports-positive-phase-3-results-for-phentolamine-ophthalmic-solution-0-75-

3. Harp MD. Opus Genetics launches phase 1/2 MERTK gene therapy trial. Published January 28, 2026. Accessed February 25, 2026. https://www.ophthalmologytimes.com/view/opus-genetics-launches-phase-1-2-mertk-gene-therapy-trial