US FDA Approves Ryzumvl, Medicine To Treat Mydriasis

The FDA has approved Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis caused by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide). Ryzumvl is projected to be accessible commercially in the United States in the first half of 2024. "The FDA's approval of Ryzumvl marks a significant milestone for our Eye Care Division and underscores Viatris' commitment to advancing eye care and enhancing access for both eye care professionals and patients," said Viatris Eye Care Division President 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. We look forward to launching Ryzumvi in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders." In the US, 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 of pharmacologically-induced mydriasis include sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive, as per pharmabiz. "We are pleased to receive FDA approval of Ryzumvi eye drops and look forward to Viatris' successful commercial execution," said Rick Rodgers, MBA, interim chief executive officer of Ocuphire. "We are grateful to the many patients and investigators who participated in our clinical trials, as well as the Ocuphire and Viatris teams for their commitment to patients."