Viatris and Ocuphire’s Ryzumvi gets FDA approval for reversing eye dilation

Viatris and Ocuphire’s Ryzumvi gets FDA approval for reversing eye dilation

Viatris has achieved a significant milestone in its pursuit of reaching $1 billion in eye care sales by 2028. The FDA granted approval for Ryzumvi, a collaborative effort between Viatris and Ocuphire, also known as phentolamine ophthalmic solution. This approval allows Ryzumvi to be utilized in the treatment of pharmacologically-induced mydriasis, which involves pupil dilation.

Viatris and Ocuphire have announced their plan to introduce Ryzumvi to the US market during the first half of 2024. The FDA had accepted Ocuphire’s application for Ryzumvi (formerly known as Nyxol) back in February. Ocuphire had previously entered into a licensing agreement with Famy Life Sciences for the development and commercialization of Ryzumvi. Viatris, on the other hand, bolstered its eye care division by completing the acquisitions of both Famy and Oyster Point Pharma for a total of $750 million in January.

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“The FDA’s approval of Ryzumvi 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. 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.”

– Viatris Eye Care Division President Jeffrey Nau, Ph.D

In the United States, approximately 100 million comprehensive eye exams occur annually, often involving pharmacologically-induced pupil dilation that can last up to 24 hours. This process can lead to undesirable side effects, such as sensitivity to light and blurred vision, making tasks like reading, working, and driving challenging. The FDA’s approval of Ryzumvi is based on the successful outcomes of the MIRA clinical trial program, which included over 600 subjects across various phases, including the MIRA-1 phase 2b trial, the MIRA-2 and -3 phase 3 trials, as well as the MIRA-4 phase 3 trial in pediatric patients. In both the MIRA-2 and MIRA-3 trials, a statistically significant percentage of subjects in the Ryzumvi group saw their pupil diameter return to baseline compared to those in the placebo group.

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Common side effects associated with Ryzumvi included discomfort at the instillation site, including sensations of pain, stinging, and burning, along with conjunctival hyperemia.

Following its acquisitions of Oyster Point and Famy, Viatris now boasts one of the largest commercial sales forces in the field of ophthalmology in the United States. Nau, the head of Viatris’ eye care division, emphasized this point during the J.P. Morgan Healthcare Conference in January, having previously served as the CEO of Oyster Point before the acquisition.

With these strategic acquisitions under its belt, Viatris has set a clear objective to achieve $1 billion in sales within the eye care segment by the year 2028.

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