FDA 提前一天批准 Ryzumvi（酚妥拉明滴眼液）扩展用于老花眼，Opus Genetics 获 Viatris 里程碑付款

Opus Genetics ( IRD ) on Friday announced that the U.S. FDA has granted a label expansion for Ryzumvi, an eye care solution it markets with Viatris ( VTRS ), allowing its use in adults with presbyopia, an age-related condition characterized by loss of clear close-up vision. The treatment, also known as phentolamine ophthalmic solution, was previously available in the U.S. for patients aged three years and older with pharmacologically induced mydriasis (dilated pupils). The approval comes after the FDA accepted the company’s supplemental New Drug Application for Ryzumvi in presbyopia earlier this year, granting October 17 as the target action date. The sNDA is backed by data from two pivotal Phase 3 trials, VEGA-2 and VEGA-3, which met their primary and all key secondary efficacy endpoints with a favorable safety profile for phentolamine ophthalmic solution. Its approval triggers a milestone payment to Opus ( IRD ) from Viatris ( VTRS ). The companies reached a license and collaboration agreement in 2022 to market the PS treatment in the U.S. and several other overseas markets.