News about FDA

The FDA last week issued a safety notice for certain delivery systems used in Edwards Lifesciences' Sapien M3 transcatheter mitral valve replacement, after three balloon bursts occurred during inflation. As of Oct. 5, Edwards reported three incidents, including one death and one serious injury. The company told customers to stop using and return devices from four lot numbers of its Commander M delivery systems. Since the Oct. 15 alert, Edwards shares (EW) have fallen 1.3% to $86.94, with a market cap of about $50 billion.

The U.S. FDA has approved Viatris' RYZUMVI (phentolamine ophthalmic solution 0.75%) for treating presbyopia, the age-related loss of near focusing ability, in adults. The drug was already approved in the U.S. for pharmacologically induced mydriasis, and the new approval expands its use. Viatris holds exclusive U.S. commercialization rights under a licensing deal with Opus Genetics and is exploring a U.S. partner to commercialize RYZUMVI for presbyopia. The most common ocular side effects reported for presbyopia were conjunctival hyperemia (21%) and instillation site irritation (16%), and the drug is not recommended for patients with active ocular inflammation.