Viatris got FDA approval on October 16 for a second indication for RYZUMVI (phentolamine ophthalmic solution 0.75%), adding presbyopia in adults to a label that already covers pharmacologically-induced mydriasis. The wrinkle: Viatris has no U.S. commercialization plan in place. The company says it is “exploring the potential for a partner” to sell the drug domestically, which means an approved product is sitting without a sales force while the presbyopia market already has at least one competitor in Allergan’s Vuity (pilocarpine HCl ophthalmic solution 1.25%), which received FDA approval for presbyopia in March 2023.
The approval rests on data from the Phase 3 VEGA-2 and VEGA-3 trials. Phentolamine works as an alpha-adrenergic antagonist, constricting the pupil through a different mechanism than pilocarpine, which is a cholinergic agonist. Whether that mechanistic distinction translates to a clinically meaningful tolerability difference will likely be a central question for any eventual commercial partner, particularly given that conjunctival hyperemia appeared in 21% of presbyopia subjects and instillation site irritation in 16% in the RYZUMVI trials. Most of those reactions were mild and self-resolving, but they are not trivial numbers for a condition people manage daily starting in their early-to-mid 40s.
The licensing structure adds another layer to watch. Viatris holds rights through a global licensing agreement with Opus Genetics, which filed and supported the supplemental NDA. Viatris retains U.S. commercialization rights but is openly signaling it wants to hand that function to someone else. That is not unusual for a company reshaping its portfolio around generics and established brands, but it does create a gap: the FDA clock is running on patent life and market exclusivity while deal discussions presumably proceed.
For readers tracking ophthalmology access, the real question is who picks up the commercialization rights and at what terms, since that decision will determine whether RYZUMVI reaches patients in any meaningful volume or spends its early years as an approved drug with limited prescriber awareness.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
