Opus Genetics announced the US Food and Drug Administration (FDA) has accepted for review the supplemental new drug application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026, the company said in a press release.
If approved, phentolamine ophthalmic solution 0.75%, a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics and improve visual acuity through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, has the potential to offer a pharmacologic treatment option for patients seeking improved visual acuity without reliance on corrective lenses, the company said.
The sNDA is supported by data from a pivotal phase 3 clinical program, including 2 trials, VEGA-2 and VEGA-3. According to Opus Genetics, both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events.
The company said it intends to have data from VEGA-3 presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April 2026 in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2026 in Denver. Phentolamine ophthalmic solution 0.75% is also being investigated across additional ophthalmic indications.
According to Opus Genetics, Ryzumvi (phentolamine ophthalmic solution 0.75%) is currently approved in the United States for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents. The sNDA seeks to expand the indication to include presbyopia.
Opus Genetics and Viatris, Inc. (through its affiliate) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize phentolamine ophthalmic solution 0.75% in the US.
“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, 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.”