• The approval was supported by data from the pivotal phase 3 VEGA-2 and VEGA-3 clinical trials.
• Phentolamine ophthalmic solution 0.75% was previously approved for pharmacologically induced mydriasis.

The FDA approved a supplemental new drug application for Ryzumvi, a preservative-free eye drop, for the treatment of presbyopia.

“Presbyopia affects approximately 90% of Americans over age 45, making everyday activities like reading, using smartphones and working on computers increasingly difficult. Many patients rely on reading glasses or other corrective lenses, creating a significant need for convenient, noninvasive treatment options,” George Magrath, MD, MBA, MS, CEO of Opus Genetics, told Healio. “Phentolamine ophthalmic solution 0.75% offers a pharmacological alternative designed to improve near vision while preserving distance vision.”

The approval was supported by data from the pivotal phase 3 VEGA-2 and VEGA-3 clinical trials, which met primary and key secondary efficacy endpoints, “demonstrating the treatment's ability to improve near vision, with no treatment-related serious adverse events reported,” Magrath said.

Ryzumvi (phentolamine ophthalmic solution 0.75%) is designed to reduce pupil diameter without engaging the ciliary muscle through a sympatholytic mechanism of action.

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. Under the terms of the agreement, the approval triggers a milestone payment to Opus Genetics.

“With FDA approval, we believe this treatment can provide millions of adults with greater flexibility in managing their near vision impairment,” Magrath told Healio.

As Healio previously reported, Ryzumvi was approved in 2023 for the treatment of pharmacologically induced mydriasis.