FDA accepts supplemental NDA for phentolamine in presbyopia

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