FDA Accepts Viatris Supplemental Application for Phentolamine Eye Drops to Treat Presbyopia
核心洞察
The FDA has accepted Viatris' supplemental New Drug Application for MR-141 (搜索) (phentolamine ophthalmic solution 0.75%) to treat presbyopia (搜索), with a PDUFA goal date of October 17, 2026.
The application is supported by positive Phase 3 data from VEGA-2 and VEGA-3 trials, which met all primary and key secondary endpoints with no treatment-related serious adverse events.
Presbyopia (搜索) affects approximately 90% of adults in the U.S. over age 45, representing nearly 128 million people who experience age-related loss of near vision focusing ability.
Viatris Inc. announced that the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for MR-141 (搜索) (phentolamine ophthalmic solution 0.75%) to treat presbyopia (搜索), an age-related vision condition affecting nearly 128 million Americans. The FDA has assigned a PDUFA goal date of October 17, 2026, for its regulatory decision.
The supplemental application seeks to expand the indication for Ryzumvi (搜索)® (phentolamine ophthalmic solution 0.75%), which is currently the only FDA-approved product for treating pharmacologically-induced mydriasis caused by adrenergic agonists or parasympatholytic agents.
Clinical Trial Results Support Application
The sNDA is backed by data from two pivotal Phase 3 trials, VEGA-2 and VEGA-3, which demonstrated positive efficacy results for this investigational non-invasive treatment option. Both trials met their primary and all key secondary endpoints, with no treatment-related serious adverse events reported.
"We are confident in the strength of the clinical data supporting our submission," said Philippe Martin, Viatris Chief R&D Officer. "Phentolamine offers a physiological approach that relaxes the iris dilator muscle (搜索) to improve near vision without engaging the ciliary muscle (搜索), which helps preserve distance vision."
Data from the VEGA-3 trial will be presented at the American Society of Cataract and Refractive Surgery meeting in April in Washington, D.C., and the Association for Research in Vision and Ophthalmology meeting in May in Denver, Colorado.
Addressing a Widespread Vision Condition
Presbyopia (搜索) represents a significant unmet medical need, affecting approximately 90% of adults in the U.S. over the age of 45. The condition is characterized by the gradual loss of near focusing ability due to aging, typically becoming noticeable in the early to mid-40s. When uncorrected, presbyopia contributes significantly to vision-related disability and impacts daily tasks and productivity.
By age 50, most Americans require some form of near-vision correction, such as reading glasses or multifocal lenses. Globally, an estimated 1.8 billion people were presbyopic in 2015, with projections indicating this number will rise to 2.1 billion by 2030.
Safety Profile and Administration
The most common adverse reactions reported with phentolamine ophthalmic solution include instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). The treatment is not recommended for patients with active ocular inflammation such as iritis.
Contact lens wearers must remove their lenses prior to instillation and wait 10 minutes after dosing before reinserting them. Care should be taken to avoid touching the vial tip to the eye or other surfaces to prevent contamination.
Development Partnership
Viatris has exclusive rights to commercialize phentolamine ophthalmic solution 0.75% in the U.S. through a global licensing agreement with Opus Genetics, which provides for the development of the treatment.