Viatris Announces US Launch of Ryzumvi for the Reversal of Mydriasis

Viatris and Ocuphire announced the US commercial launch of Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States. Ryzumvi is the only US commercially available FDA-approved eye drop to reverse dilation.[1]  

The FDA approved Ryzumvi, formerly known as Nyxol, in September 2023. It was evaluated across 2 randomized, vehicle-controlled, double-masked MIRA-2 and MIRA-3 clinical trials in which patients (N=553) aged 12 to 80 years who had mydriasis induced by instillation of phenylephrine, tropicamide, or Paremyd (hydroxyamphetamine hydrobromide and tropicamide) were administered 2 drops (in the study eye) or 1 drop (in the fellow eye) of either Ryzumvi or placebo 1 hour after instillation of the mydriatic agent. 

The onset of action of Ryzumvi generally occurs in 30 minutes. In the MIRA-2 and MIRA-3 clinical trials, at 90 minutes after administration, 49% and 58% of patients administered 2 drops of Ryzumvi returned to ≤ 0.2 mm of baseline pupil diameter compared to 7% and 6% of patients administered placebo, respectively. In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours. In the MIRA-3 trials' placebo group, 28% of patients were still dilated at 24 hours.[1]

Ryzumvi is not recommended to be used in patients with active ocular inflammation (e.g., iritis). Contact lens wearers should be advised to remove their lenses prior to the instillation of Ryzumvi and wait 10 minutes after dosing before reinserting their contact lenses.[1] The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%).

In November 2022, Ocuphire Pharma announced it entered into an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol (Ryzumvi) across three indications in US, Europe, Japan, India, China and other global markets. In a separate deal with Famy, Viatris agreed to commercialize Nyxol following each regulatory approval. View EyewireTV's coverage of the deal here. Under the terms of this agreement, Ocuphire is eligible to receive regulatory and commercial milestones as well as royalties.

For more information on Ryzumvi, visit https://www.ryzumvi.com/.

Reference

1. RYZUMVI (phentolamine ophthalmic solution). Prescribing Information. FamyGen Life Sciences.