Opus Genetics Announces U.S. Food And Drug Administration Acceptance Of Its Supplemental New Drug Application For Phentolamine Ophthalmic Solution 0.75% For The Treatment Of Presbyopia

Opus Genetics, Inc., listed on Nasdaq under IRD, announced that the U.S. Food and Drug Administration has accepted for review the Company’s supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2026, marking a key regulatory step for a potential new option in an area with high unmet need. Opus Genetics is a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases, and this submission reflects its growing work across broader ophthalmic conditions.

Presbyopia is a common age-related vision impairment that reduces the ability to focus on near objects and affects millions globally. In the United States, it impacts nearly 90% of adults over age 45, often requiring reading glasses or other forms of visual correction. If approved, phentolamine ophthalmic solution 0.75% could provide patients with a pharmacologic approach to improve near vision without depending on corrective lenses. This potential shift toward a non-invasive, drop-based option highlights ongoing advancements in ophthalmic therapeutics aimed at reducing reliance on external visual aids.

George Magrath, M.D., Chief Executive Officer of Opus Genetics, described the FDA’s acceptance of the sNDA as a meaningful milestone for the company and for patients seeking alternatives to traditional presbyopia management. He noted that the formulation is intended to enhance near vision while maintaining distance vision, supported by a sustained effect on pupil diameter lasting up to 20 hours. He emphasized that the company continues to progress toward expanding treatment choices for patients in need of improved visual outcomes.

Phentolamine ophthalmic solution 0.75% is a preservative-free topical product formulated to adjust pupil dynamics through a sympatholytic mechanism of action. Unlike approaches that target the ciliary muscle, this mechanism offers a distinct pathway for improving visual acuity, making it a differentiated candidate within the presbyopia treatment landscape.

The sNDA is backed by a pivotal Phase 3 program consisting of two major clinical trials, VEGA-2 and VEGA-3. Both studies demonstrated positive efficacy and met the primary and all key secondary endpoints, without any treatment-related serious adverse events. The company plans to present data from the VEGA-3 trial at key ophthalmology conferences, including the annual meeting of the American Society of Cataract and Refractive Surgery in April 2026 in Washington, D.C., and at the Association for Research in Vision and Ophthalmology meeting in May 2026 in Denver, Colorado. Beyond presbyopia, phentolamine ophthalmic solution 0.75% is also under investigation for additional ophthalmic uses.

The product is already approved in the U.S. under the brand name Ryzumvi for reversing pharmacologically induced mydriasis caused by agents such as phenylephrine or tropicamide. It remains the only FDA-approved commercial therapy for this indication. With the current sNDA, Opus Genetics seeks to broaden its use to include the treatment of presbyopia, potentially positioning it as a multipurpose ophthalmic solution.

Opus Genetics also maintains a global licensing partnership with Viatris, Inc., through which Viatris holds exclusive U.S. commercialization rights for phentolamine ophthalmic solution 0.75%. This collaboration supports the development, regulatory advancement, and eventual market access strategy for the product as its evaluation expands across both presbyopia and other ophthalmic conditions.