As Viatris seeks growth in eye care, its Ocuphire-partnered dilation drop Ryzumvi wins FDA nod

Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028.

The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S. in the first half of 2024, Viatris and Ocuphire said in a release.

The FDA accepted Ocuphire’s application for Ryzumvi, previously known as Nyxol, in February. Ocuphire had previously entered into a licensing agreement for development and commercialization of Ryzumvi with Famy Life Sciences. Viatris closed its $750 million acquisitions of Famy and Oyster Point Pharma in January on the way to establishing its own eye care division.

In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically induced dilation of the pupils, which can last up to 24 hours, Viatris said. The process can lead to side effects like sensitivity to light and blurred vision, which can make it difficult to read, work and drive, Viatris said.

The FDA’s approval is based on Ryzumvi’s MIRA clinical trial program, which enrolled more than 600 subjects across the MIRA-1 phase 2b trial, the MIRA-2 and -3 phase 3 trials, plus the MIRA-4 phase 3 trial in kids. The percentage of subjects with study eyes returning to their baseline pupil diameter was statistically significant in the Ryzumvi group versus placebo across both the MIRA-2 and MIRA-3 trials, according to the companies.

The most common Ryzumvi side effects included instillation site discomfort, including pain, stinging and burning and conjunctival hyperemia.

Following its acquisition of Oyster Point and Famy, Viatris now boasts “one of the largest commercial sales forces” in ophthalmology in the U.S., Viatris eye care division head Nau said at the J.P. Morgan Healthcare Conference in January. Nau served as Oyster Point’s CEO before the Viatris buyout.

With the recent acquisitions in hand, Viatris has set a goal to reach $1 billion in eye care sales by 2028.