The solution was originally approved to treat pharmacologically induced mydriasis.
The FDA accepted a supplemental new drug application to expand the indication for Ryzumvi to include the treatment of presbyopia, according to press releases from Opus Genetics and Viatris.
“Phentolamine is designed to improve near vision by modulating the iris to support a smaller pupil in a controlled, functional range,” George Magrath, MD, MBA, MS, CEO of Opus Genetics, told Healio. “This extends the depth of focus while aiming to preserve a natural visual experience. … Opus is advancing it specifically for presbyopia with a formulation and development program tailored to this indication.”
Since 2021, four drops have been approved to treat presbyopia.
Ryzumvi (phentolamine ophthalmic solution 0.75%, Opus Genetics/Viatris) was originally approved in 2023 for the treatment of pharmacologically induced mydriasis.
The FDA set a Prescription Drug User Fee Act goal date of Oct. 17.
The supplemental NDA was supported by data from two phase 3 trials, VEGA-2 and VEGA-3. In both trials, phentolamine met all primary and key secondary endpoints and had no treatment-related serious adverse events.
Phentolamine previously received fast track designation for the treatment of chronic night driving impairment after keratorefractive surgery.
A global licensing agreement between Opus Genetics and Viatris provides for the development of phentolamine ophthalmic solution 0.75%, with exclusive rights granted to Viatris to commercialize it in the United States.
“Viatris brings established capabilities in late-stage development, regulatory execution, manufacturing and commercialization, while Opus remains focused on building its pipeline of gene therapies for inherited retinal diseases,” Magrath said. “The collaboration allows each organization to play to its strengths, with Viatris supporting advancement and, if approved, commercialization of phentolamine, and Opus continuing to invest in its core IRD gene therapy portfolio.”
