Opus Genetics Gets FDA Approval for Presbyopia Treatment

RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2026 /CourierPR/ -- Opus Genetics, a clinical-stage biopharmaceutical company focused on developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults. This approval marks a significant milestone for Opus Genetics, representing its second U.S. drug approval and further solidifying its clinical and regulatory capabilities.

The FDA’s approval is based on positive results from pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials, which met primary and all key secondary efficacy endpoints. The trials demonstrated that phentolamine ophthalmic solution 0.75% effectively improved near vision while preserving distance vision, a condition known as presbyopia. Approximately 90% of adults in the United States over the age of 45 are affected by this age-related condition, which affects the ability to focus on near objects, often requiring reading glasses or other corrective lenses.

The FDA approval of phentolamine ophthalmic solution 0.75% for presbyopia in adults will trigger a milestone payment to Opus Genetics. The solution is a preservative-free, topical formulation that reduces pupil diameter through a sympatholytic mechanism of action, without engaging the ciliary muscle. This non-invasive pharmacologic treatment offers a new and effective option for patients suffering from presbyopia.

Phentolamine ophthalmic solution 0.75% is marketed in the United States as RYZUMVI® for the treatment of pharmacologically-induced mydriasis. The supplemental approval expands its approved indications to include presbyopia in adults. The solution is indicated for the treatment of both presbyopia and pharmacologically-induced mydriasis, which can be caused by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide) in adults and pediatric patients 3 years of age and older.

The most common ocular adverse reactions reported in > 5% of subjects were conjunctival hyperemia (21%) and instillation site irritation (16%). The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%). The majority of the adverse reactions were mild, transient, and self-resolving.

The FDA approval is supported by positive results from the pivotal Phase 3 VEGA-2 and VEGA-3 clinical trials, both of which met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported.

Phentolamine ophthalmic solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. It works by blocking alpha-1 adrenergic receptors on the iris dilator muscle. The solution is marketed in the United States as RYZUMVI® for the treatment of pharmacologically-induced mydriasis and is currently approved for adults and pediatric patients 3 years of age and older.