Key Takeaways

  • The FDA has accepted Opus Genetics’ sNDA for phentolamine ophthalmic solution 0.75% for presbyopia, assigning a PDUFA goal date of October 17, 2026.

  • The application is supported by positive Phase 3 data from the VEGA-2 and VEGA-3 trials.

  • If approved, the preservative-free ophthalmic solution could provide a noninvasive pharmacologic option for presbyopia.

The FDA has accepted for review Opus Genetics' supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% as a treatment for presbyopia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2026.

“The FDA’s acceptance of our sNDA marks an important milestone in expanding the potential use of phentolamine ophthalmic solution as a differentiated approach to managing presbyopia,” said George Magrath, MD, Chief Executive Officer of Opus Genetics. “Phentolamine is targeted to improve near vision while preserving distance vision, with a sustained effect on pupil diameter of up to 20 hours. Our team continues to make tremendous progress in advancing our mission to bring meaningful new ophthalmic treatment options to patients.”

Phentolamine ophthalmic solution 0.75% 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 sNDA submission is supported by data from a pivotal phase 3 clinical development program, including the VEGA-2 and VEGA-3 trials. Both studies demonstrated positive efficacy outcomes, meeting primary and all key secondary endpoints. The investigational, noninvasive treatment option showed no treatment-related serious adverse events in the trials.

Opus Genetics plans to present data from the VEGA-3 trial at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April 2026 in Washington, D.C., and at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2026 in Denver. The company is also evaluating phentolamine ophthalmic solution 0.75% across additional ophthalmic indications.

Marketed in the United States as Ryzumvi for the treatment of pharmacologically induced mydriasis caused by adrenergic agonists (such as phenylephrine) or parasympatholytic agents (such as tropicamide), phentolamine ophthalmic solution 0.75% is currently the only FDA-approved product for this indication. The supplemental application seeks to expand the approved label to include presbyopia.

Opus Genetics and Viatris, Inc. (through its affiliate) are parties to a global licensing agreement covering the development of phentolamine ophthalmic solution 0.75%. Under the agreement, Viatris holds exclusive US commercialization rights to the product.