FDA Approves Drop for Drug-Induced Dilation of the Pupils

The FDA has approved Ryzumvi (phentolamine ophthalmic solution) to treat drug-induced dilation of the pupils. Developed by Viatris and Ocuphire Pharma, Ryzumi is indicated for patients who have received adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) for dilation. It is expected to be available in the first half of 2024. Company officials are not revealing a price at this time, and a company spokesperson said pricing information will be available at the time of launch.

In the United States, an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils, which can last up 24 hours. Side effects dilation include sensitivity to light and blurred vision, which may make it difficult to read, work and drive.

Ryzumi, previously called Nyxol by Ocuphire, is a preservative-free formulation of phentolamine that inhibits the contraction of the smooth muscle of the iris.

Jeffrey Nau, Ph.D.

“Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases. Our hope is that by addressing patient dilation barriers, we're empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes,” Viatris Eye Care Division President Jeffrey Nau, Ph.D., said in a press release.

The approval was based on the MIRA clinical trial program involving more than 600 patients. In the MIRA-2 and MIRA-3 trials, a total of 553 subjects aged 12 to 80 years were enrolled. The studies compared two drops or one drop of Ryzumvi with placebo administered one hour after instillation of the dilating agent. A greater percentage of patients receiving two drops of Ryzumvi achieved baseline pupil diameter than placebo. The efficacy was similar for all age ranges including pediatric patient 3 to 17 years of age.

The most common ocular adverse reactions reported were instillation site discomfort including pain, stinging and burning (16%) and conjunctival hyperemia (12%). The only non-ocular adverse reaction was dysgeusia (6%), which is a metallic taste in the mouth.

Viatris and Ocuphire have also partnered for the development of phentolamine to address presbyopia (the inability to see things up close) and night vision disturbances.