RESEARCH TRIANGLE PARK, N.C., October 16, 2026
Opus Genetics, Inc. (NASDAQ: IRD), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75%, marketed as RYZUMVI®, for the treatment of presbyopia in adults. The approval expands RYZUMVI’s existing U.S. indication for pharmacologically induced mydriasis, or pupil dilation caused by certain medications. Presbyopia is an age-related condition that reduces the ability to focus on nearby objects and commonly leads to the use of reading glasses or other corrective lenses. Opus estimates that the condition affects approximately 90% of adults over age 45 in the United States. The company said the approval triggers a milestone payment under its licensing agreement with Viatris, which holds exclusive U.S. commercialization rights through an affiliated entity.
FDA Approval Supported by Two Phase 3 Trials
The FDA’s decision was supported by positive results from the pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials. According to Opus Genetics, both studies met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported. The approval introduces an additional pharmacological option for adults with presbyopia, a condition associated with age-related changes in near-vision focusing ability. RYZUMVI is a preservative-free, topical ophthalmic solution administered as eye drops. Its mechanism of action involves reducing pupil diameter through a sympatholytic effect without engaging the ciliary muscle. By reducing pupil size, the treatment is designed to improve near vision while preserving distance vision. The company did not provide detailed numerical efficacy results from VEGA-2 and VEGA-3 in its announcement. The approval represents Opus Genetics’ second U.S. drug approval, according to Chief Executive Officer George Magrath, M.D., who highlighted the contribution of patients, investigators and clinical sites to the development program.
RYZUMVI Expands Its Existing Ophthalmic Indications
Before the supplemental approval, phentolamine ophthalmic solution 0.75% was approved in the United States for treating pharmacologically induced mydriasis caused by adrenergic agonists, such as phenylephrine, or parasympatholytic agents, such as tropicamide. The updated labeling adds presbyopia in adults while retaining the existing mydriasis indication for adults and pediatric patients aged three years and older. Phentolamine is a non-selective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size by blocking alpha-1 adrenergic receptors on the iris dilator muscle. The treatment’s safety profile includes ocular adverse reactions that vary by indication. In presbyopia studies, the most common ocular adverse reactions reported in more than 5% of participants were conjunctival hyperemia (21%) and instillation-site irritation (16%). For pharmacologically induced mydriasis, the most common ocular reactions were instillation-site discomfort, including pain, stinging and burning (16%), and conjunctival hyperemia (12%). Dysgeusia, or altered taste, was the most common non-ocular adverse reaction in that setting, reported in 6% of participants. Most reported adverse reactions were mild, transient and self-resolving.
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Opus Genetics and Viatris Advance Commercialization
Opus Genetics and Viatris are parties to a global licensing agreement covering the development of phentolamine ophthalmic solution 0.75%, with Viatris holding exclusive rights to commercialize the product in the United States. The approval for presbyopia triggers a milestone payment to Opus Genetics and expands the product’s approved use in ophthalmology. RYZUMVI is not recommended for patients with active ocular inflammation, such as iritis. Patients should avoid touching the vial tip to the eye or other surfaces to reduce the risk of injury or contamination. Contact lens wearers should remove their lenses before administration and wait 10 minutes after dosing before reinserting them. Beyond phentolamine, Opus Genetics is developing gene therapies intended to restore vision and prevent blindness in inherited retinal diseases. Its pipeline includes seven adeno-associated virus (AAV)-based programs targeting conditions associated with genes including LCA5, BEST1, RDH12, MERTK, RHO, CNGB1 and NMNAT1. The company is also evaluating phentolamine in a Phase 3 program for dim-light vision disturbances following corneal refractive surgery.
Source:::Opus Genetics,press release
