FDA Accepts Review of Eye Drop Aimed at Replacing Reading Glasses
The FDA's acceptance of the sNDA for phentolamine ophthalmic solution 0.75% follows positive Phase 3 VEGA trial results showing 27.2% of patients improved near vision without affecting distance vision.
16 Articles
16 Articles
Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia...
FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia
/PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...
Viatris, Opus Genetics’ Investigational Phentolamine Ophthalmic Solution Demonstrates Strong Results in Presbyopia Trial
Results from the Phase III VEGA-3 trial show that a significantly higher number of patients with presbyopia who received MR-141 achieved a ≥3-line gain in binocular near visual acuity without compromising distance vision compared to placebo.
FDA Accepts Viatris Supplemental Application for Phentolamine Eye Drops to Treat Presbyopia
Viatris Inc. announced that the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for MR-141 (phentolamine ophthalmic solution 0.75%)Search drug to treat presbyopia disease, 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.
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