Opus Genetics wins FDA approval for presbyopia eye drops

FDA approval has expanded Ryzumvi's use to adult presbyopia as Opus Genetics, Inc. NASDAQIRD announced a new indication for its 0.75 per cent phentolamine eye drops on Friday. The decision triggers a milestone payment, although the Oct. 16 announcement does not disclose its amount.

Commercial rights in the United States belong exclusively to Viatris Inc. NASDAQVTRS, under the partners' global licensing agreement. Ryzumvi is already marketed for drug-induced pupil dilation, but Friday's notice provides no presbyopia-specific launch date or price. The approval announcement precedes the Oct. 17 review goal that Viatris disclosed in February.

Opus is a small North Carolina ophthalmology developer advancing gene therapies for inherited retinal diseases alongside its licensed eye-drop asset.

Opus shares traded at US$3.92 on Nasdaq at 12:13 p.m. EDT on Friday, down US$0.13, according to NASDAQIRD.

The expanded indication covers presbyopia in adults, the age-related loss of ability to focus on nearby objects. It adds to the existing indication for reversing pharmacologically induced dilation in adults and children aged three and older.

The preservative-free drops reduce pupil diameter by blocking adrenergic receptors on the iris dilator muscle. Opus says the mechanism avoids engaging the ciliary muscle, which helps distinguish its approach within the prescription near-vision market.

"This FDA approval in presbyopia will trigger a milestone payment to Opus Genetics," the company said in its Oct. 16 release.

The Approval Adds Another Prescription Option

LENZ Therapeutics, Inc. NASDAQLENZ received FDA approval for Vizz, its aceclidine ophthalmic solution, on July 31, 2025. That product is also indicated for adult presbyopia, making it an existing approved competitor.

LENZ shares traded at US$3.25 on Nasdaq at 12:24 p.m. EDT on Friday, down US$0.32, according to NASDAQLENZ.

LENZ's approval announcement estimated the U.S. presbyopia population at approximately 128 million adults. That estimate describes people with the condition, rather than the number who will seek prescription drops or generate sales for either company.

Opus's approval rests on the pivotal VEGA-2 and VEGA-3 studies, which the company says met their primary and key secondary endpoints. Its June 26, 2025 VEGA-3 report describes 545 participants randomized between phentolamine and placebo in a three-to-two ratio, with once-daily evening administration.

The primary endpoint required at least a three-line gain in binocular distance-corrected near vision while losing fewer than five letters of best-corrected distance vision. Investigators assessed that response 12 hours after dosing on day eight.

The response rate was 27.2 per cent with phentolamine, compared with 11.5 per cent on placebo. The comparison was statistically significant, with p less than 0.0001.

Friday's notice reports no treatment-related serious adverse events in the pivotal trials; the most common presbyopia adverse reactions were eye redness and instillation-site irritation, at 21 and 16 per cent respectively. The safety information advises against use in active ocular inflammation.

Royalties Sit Alongside The Gene-Therapy Pipeline

The original licence announcement, dated Nov. 7, 2022, provided for tiered double-digit royalties on worldwide net sales through 2040, plus sales milestones. It did not specify the presbyopia approval payment now triggered.

At June 30, Opus held US$88.8 million in cash and equivalents, according to its Aug. 6 financial update. Management's runway estimate into 2029 included potential future note funding and excluded milestone payments and callable warrant proceeds.

That update scheduled fourth-quarter 2026 dosing in the OPGx-LCA5 registration trial for inherited retinal disease. Topline results were expected by the end of 2027, providing evidence for the gene therapy's potential approval.