Opus Genetics, Inc. Files Supplemental New Drug Application for Phentolamine Ophthalmic Solution

On December 17, 2025, Opus Genetics, Inc. announced that its global commercialization partner, Viatris Inc., filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for Phentolamine Ophthalmic Solution 0.75% (Phentolamine) for the treatment of presbyopia. This filing is supported by positive results from the VEGA-3 Phase 3 clinical trial, which corroborated the efficacy, safety, and durability of response observed in the VEGA-2 study. However, there is no guarantee that the FDA will accept the sNDA for filing, deem it complete, or proceed with a review on the expected timeline, if at all.