FDA approves RYZUMVI for pharmacologically-induced mydriasis in the U.S.

Viatris Inc. and Ocuphire Pharma, Inc. have received the go-ahead from the U.S. Food and Drug Administration (FDA) for their eye product, RYZUMVI (phentolamine ophthalmic solution) 0.75%. 

In February, Ocuphire’s application for Ryzumvi, formerly referred to as Nyxol, received the FDA’s approval. Prior to this, Ocuphire had engaged in a licensing agreement with Famy Life Sciences for the development and commercialization of Ryzumvi. Meanwhile, Viatris completed its acquisitions of both Famy and Oyster Point Pharma for a total of $750 million in January, as part of its strategic initiative to establish its dedicated eye care division.

RYZUMV represents a specialized eye drop solution formulated to tackle the typical adverse effects linked to medically-induced mydriasis, a condition that can persist for as long as 24 hours in both adults and children. During eye dilation, individuals may encounter issues such as sensitivity to light (photophobia) and blurred vision, which can disrupt everyday activities like reading, working, and driving. These challenges have sparked the demand for an effective solution.

The FDA’s green light for RYZUMVI comes after an extensive assessment within the comprehensive MIRA clinical trial program, encompassing over 600 subjects across various age groups. Remarkably, the trials showcased statistically significant enhancements in subjects’ pupil diameters following the use of RYZUMVI when compared to a placebo, confirming its effectiveness. The product’s capacity to alleviate the discomfort and visual disruptions linked to pharmacologically-induced mydriasis positions it as a transformative force in the field of ophthalmology.

Dr. Jeffrey Nau, President of Viatris Eye Care Division, conveyed his excitement regarding this milestone, highlighting Viatris’ dedication to advancing eye care and enhancing accessibility for both eye care practitioners and patients. He emphasized the importance of thorough dilated eye examinations for the early detection of vision-affecting illnesses. Through the introduction of RYZUMVI, Viatris aspires to empower eye care professionals to increase the accessibility of these examinations, ultimately resulting in better outcomes for eye health.

Rick Rodgers, MBA, Acting CEO of Ocuphire, expressed gratitude towards the patients and researchers who took part in the clinical trials. He also praised the cooperative endeavors of both Ocuphire and Viatris teams in successfully bringing RYZUMV to reality.

The MIRA clinical trial program consisted of various stages, including the MIRA-1 Phase 2b trial, MIRA-2, the pivotal Phase 3 trials MIRA-3, and the pediatric Phase 3 trial MIRA-4. These trials involved a wide age range of participants, from 3 to 80 years old, ensuring that the product’s effectiveness could be assessed across diverse demographics.

RYZUMVI does come with potential side effects, with the most common adverse reactions related to the eyes being discomfort at the site of instillation, which includes sensations like pain, stinging, and burning (16%), as well as conjunctival hyperemia (12%). Additionally, dysgeusia, a taste disorder (6%), was reported as a non-eye-related adverse reaction.

Pharmacologically-induced mydriasis affects approximately 100 million eye exams conducted annually in the U.S., underscoring the pressing need for an effective solution. 

The collaborative effort of Viatris and Ocuphire has yielded promising results, with the FDA’s endorsement clearing the path for the commercial availability of RYZUMVI in the U.S. during the first half of 2024. This development aligns with Viatris’ goal of achieving $1 billion in eye care sales by 2028.

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