Opus reports FDA approval of phentolamine eye drops for presbyopia
Published in Diseases!, Drugs development & discovery.
Published October 16, 2026.
Opus Genetics announced on October 16 that the U.S. FDA approved phentolamine ophthalmic solution 0.75% for adults with presbyopia, the age-related difficulty focusing on nearby objects. The decision expands the indications for RYZUMVI, previously approved for reversing drug-induced pupil dilation.
The company says the approval was supported by the Phase 3 VEGA-2 and VEGA-3 trials, which achieved their primary and key secondary efficacy endpoints. The preservative-free drops reduce pupil diameter without engaging the ciliary muscle. Viatris holds exclusive U.S. commercialization rights.
Safety and context: According to the announcement, the presbyopia studies reported eye redness in 21% of participants and irritation at the application site in 16%. No treatment-related serious adverse events were reported. These findings do not mean the treatment is risk-free or reverses biological aging. This announcement concerns U.S. approval; it does not establish Canadian authorization or availability.
Source: Opus Genetics announcement, October 16, 2026.