Key Takeaways

  • The FDA approved Ryzumvi (phentolamine ophthalmic solution 0.75%) for presbyopia in adults

  • Phase 3 VEGA-2 and VEGA-3 trials met primary and key secondary efficacy endpoints, with no treatment-related serious adverse events

  • Viatris holds exclusive US commercialization rights

The FDA has approved Opus Genetics' supplemental new drug application (NDA) for Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults, expanding the drug's existing indication for reversal of pharmacologically induced mydriasis.

The approval provides an additional noninvasive pharmacologic treatment option for presbyopia. Ryzumvi is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics through a sympatholytic mechanism of action. By avoiding engagement of the ciliary muscle, the therapy aims to improve visual acuity while maintaining distance vision.

The approval was supported by results from the pivotal phase 3 VEGA-2 and VEGA-3 clinical trials. Both studies met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported.

“This approval marks an important milestone for Opus Genetics, representing our second US drug approval and underscoring our clinical and regulatory capabilities,” said George Magrath, MD, CEO of Opus Genetics.

Opus Genetics has a global licensing agreement with Viatris, through an affiliated entity, covering the development of phentolamine ophthalmic solution 0.75%. Under the agreement, Viatris holds exclusive US commercialization rights.

The expanded FDA approval will trigger a milestone payment to Opus Genetics, although the company did not disclose the payment amount.

Ryzumvi is already marketed in the United States for the reversal of pharmacologically induced mydriasis. The new indication broadens its potential clinical use to adults with presbyopia, which affects approximately 90% of US adults older than 45, according to the company.