Opus Genetics Secures FDA Approval For Eye Drops – Set To Receive Milestone Payment

• Ryzumvi contains phentolamine ophthalmic solution 0.75%, which reduces pupil size to improve near vision without affecting longer-distance vision.
• The approval was supported by two Phase 3 trials.
• Opus is studying Ryzumvi for vision problems in dim lighting after laser eye surgery.

Opus Genetics (IRD) was in the spotlight on Friday, after the U.S. Food and Drug Administration approved its eye drop for treating presbyopia, an age-related condition that makes it difficult to focus on nearby objects.

The approval expands the use of an already commercialized therapy and triggers a milestone payment from commercial partner Viatris (VTRS).

At the time of writing, IRD shares were trading 3.4% lower, while VTRS stock gained about 1%.

Approval Based On Two Phase 3 Trials

Opus’ Ryzumvi contains phentolamine ophthalmic solution 0.75%, which reduces pupil size to improve near vision without affecting longer-distance vision. The approval was supported by two Phase 3 trials, VEGA-2 and VEGA-3, which met their primary and key secondary goals without serious treatment-related side effects.

Notably, 27.2% of patients receiving the eye drop saw an improvement of at least 15 letters (three lines) on an eye chart, compared with 11.5% receiving a placebo.

The drug previously received FDA approval in September 2023 to reverse pupil dilation caused by medications used during eye examinations. Viatris launched it commercially in April 2024.

The companies’ licensing agreement dates back to November 2022, when Ocuphire Pharma, which acquired Opus in October 2024, granted Viatris the rights to commercialize the treatment.

The agreement included $35 million upfront, up to $130 million in milestone payments, and royalties.

IRD Finances To Support Operations Into 2029

Opus is developing gene therapies for inherited retinal diseases, including OPGx-BEST1 for Best disease and OPGx-LCA5 for severe inherited vision loss. The company is also studying Ryzumvi for vision problems in dim lighting following laser eye surgery.

Opus reported $88.8 million in cash and cash equivalents as of June 30, and has a financing option of up to $120 million under an agreement with Oberland Capital. The company expects its cash position to support operations into 2029.

IRD, VTRS See Strong Gains In 2026

Retail sentiment surrounding both IRD on Stocktwits flipped to ‘extremely bullish’ from ‘neutral’ over the past 24 hours, amid ‘high’ message volumes. Meanwhile, sentiment for VTRS remained ‘neutral’.

IRD shares have seen strong buying interest so far this year, surging 84%. Meanwhile, VTRS stock has gained about 48%.

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