Opus Genetics, Inc. and Viatris, Inc. announced the FDA has accepted a supplemental new drug application (sNDA) for phentolamine ophthalmic solution (POS) 0.75% for the treatment of presbyopia.
First, a quick recap on what an sNDA is …
An sNDA is typically filed to make proposed changes to a product that has already received FDA approval.
These changes can range from minor to major, potentially impacting a product’s safety or effectiveness via a new indication, dosage, form, or even manufacturing adjustments.
And in this case—what’s the FDA-approved product?
That would be Viatris’ RYZUMVI (phentolamine ophthalmic solution 0.75%), which was approved in September 2023 for the treatment of pharmacologically induced mydriasis caused by adrenergic agonists or parasympatholytic agents.
Got it. So tell me about this solution.
Formulated as an antimicrobial, preservative-free (PF), topical eye drop solution, POS 0.75% features phentolamine as its active ingredient.
- What this is: A reversible, nonselective alpha-1 and alpha-2 adrenergic agonist with antimicrobial properties.
Also: See here for the latest details on another indication it’s under clinical investigation for.
So how does POS 0.75% work?
When administered as an eye drop, the solution reduces pupil size (diameter) by blocking the alpha-1 receptors found on the radial iris dilator muscles (activated by the alpha-1 adrenergic receptors)—without affecting the ciliary muscle.
In other words: “Phentolamine offers a physiological approach that relaxes the iris dilator muscle to improve near vision without engaging the ciliary muscle, which helps preserve distance vision," noted Philippe Martin, chief research & development (R&D) officer at Viatris.
And what clinical data is this sNDA acceptance based on?
That would be positive efficacy results from a pivotal phase 3 clinical program encompassing two randomized, double-masked, placebo-controlled, multicenter trials:
- VEGA-2 (NCT05646719)
- Concluded
- VEGA-3 (NCT06542497)
- Ongoing
Importantly: Both studies have met their primary and secondary endpoints.
Can we get specifics on this data?
We certainly can. In fact, the most recent data we reported on were topline findings from the ongoing VEGA-2 trial (released in late June 2025).
Based on that readout:
- The study met its primary endpoint, demonstrating a statistically significant (27.2%) number of POS 0.75%-treated participants achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA)
- A reported 20.6% of POS 0.75%-treated patients achieved ≥15-letter Early Treatment Diabetic Retinopathy Scale (ETDRS; ≥3-line) gain in DCNVA at 1-hour post-dose on Day 1
Any notable adverse events between the two studies?
There were no reports of any treatment-related serious adverse events (AEs), and no evidence of tachyphylaxis across the studies’ 6-week periods.
The most common treatment-emergent AEs can be found here.
And you mentioned the VEGA-3 trial is ongoing?
Indeed it is. According to Clinical Trials, the study is estimated to conclude in May 2026.
Notably: New data from the study is expected to be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May in Denver, Colorado.
Nice! Now, when should we hear from the FDA on its sNDA decision?
A Prescription Drug User Fee Act (PDUFA) date of Oct. 17, 2026 has been set.
And keep in mind: While Opus Genetics and Viatris (via an affiliate) have partnered on POS 0.75%'s clinical development via a global licensing agreement, Viatris has received the exclusive U.S. rights for the eye drop’s future U.S. commercialization.