Opus Genetics announced that the FDA approved its supplemental new drug application for phentolamine ophthalmic solution 0.75% (Ryzumvi) for the treatment of presbyopia.

Phentolamine ophthalmic solution 0.75% is a preservative-free, topical formulation that reduces pupil diameter through a sympatholytic mechanism of action without engaging the ciliary muscle. The FDA approval is supported by positive results from the phase 3 VEGA-2 and VEGA-3 clinical trials, both of which met their primary and key secondary efficacy endpoints, with no treatment-related serious adverse events reported.

Phentolamine ophthalmic solution 0.75% is already marketed in the United States for the treatment of pharmacologically induced mydriasis; this supplemental approval expands its approved indications to include presbyopia in adults.