Viatris has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75 percent) for the treatment of presbyopia, an age-related condition that impairs near vision. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 17, 2026.

Presbyopia is a progressive loss of the eye’s ability to focus on nearby objects, typically becoming noticeable in individuals in their early to mid-40s. The condition affects nearly 128 million people in the United States—approximately 90 percent of adults over the age of 45—and is associated with blurred near vision and eye strain, often requiring reading glasses or multifocal lenses. Globally, an estimated 1.8 billion people were affected in 2015, a number projected to rise to 2.1 billion by 2030.

The sNDA submission is supported by data from the pivotal Phase III clinical programme, including the VEGA-2 and VEGA-3 trials. Both studies met their primary and key secondary endpoints, demonstrating positive efficacy results for the investigational, non-invasive treatment, with no treatment-related serious adverse events reported. Data from the VEGA-3 trial are scheduled to be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in Washington, DC, and the Association for Research in Vision and Ophthalmology (ARVO) meeting in Denver, Colorado.

Phentolamine ophthalmic solution 0.75 percent is designed to provide a physiological approach to improving near vision by relaxing the iris dilator muscle without engaging the ciliary muscle, thereby helping preserve distance vision. Currently marketed in the US as Ryzumvi, the product is approved for reversing pharmacologically induced mydriasis caused by adrenergic agonists or parasympatholytic agents. The supplemental application seeks to expand its indication to include presbyopia.

Under a global licensing agreement with Opus Genetics, Viatris holds exclusive US commercialisation rights for phentolamine ophthalmic solution 0.75 percent.

Ryzumvi is not recommended for patients with active ocular inflammation such as iritis. The most commonly reported adverse reactions include instillation site discomfort (16 percent), conjunctival hyperemia (12 percent), and dysgeusia (6 percent). Contact lens wearers are advised to remove lenses prior to administration and wait 10 minutes before reinsertion.

Viatris stated that the FDA’s acceptance of the sNDA underscores progress in advancing its innovative pipeline and its commitment to addressing significant unmet needs in vision care.