FDA Accepts Viatris Supplemental Application for MR-141 in Presbyopia
Thursday, February 26, 2026
Viatris Inc. has announced that the US Food and Drug Administration has accepted for review its supplemental New Drug Application for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. The application has been assigned a PDUFA target date of 17 October 2026.
Presbyopia is an age-related condition that gradually reduces the ability to focus on close objects, leading to blurred near vision and eye strain. It affects around 90% of adults in the United States aged over 45.
The submission is supported by data from a pivotal Phase III programme, including the VEGA-2 and VEGA-3 trials. Both studies met their primary and key secondary endpoints and reported no treatment-related serious adverse events. Results from VEGA-3 are scheduled to be presented at the American Society of Cataract and Refractive Surgery meeting in April in Washington, D.C., and at the Association for Research in Vision and Ophthalmology meeting in May in Denver, Colorado.
Phentolamine ophthalmic solution 0.75% works by relaxing the iris dilator muscle to improve near vision, without affecting the ciliary muscle, which helps maintain distance vision. The product is currently marketed in the United States under the brand name Ryzumvi for the treatment of pharmacologically induced mydriasis caused by adrenergic agonists or parasympatholytic agents. It is the only FDA-approved product available for this use. The supplemental application seeks to extend its indication to include presbyopia.
Opus Genetics and Viatris, through one of its affiliates, have a global licensing agreement covering the development of phentolamine ophthalmic solution 0.75%. The agreement grants Viatris exclusive rights to commercialise the product in the United States.
Source: prnewswire.com
