FDA approves Ryzumvi for presbyopia

On October 16, 2026, FDA approved Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of presbyopia in adults. The eye drop was previously approved for the reversal of pharmacologically induced mydriasis and now offers a prescription, nonsurgical treatment option for age-related near vision loss.

Presbyopia affects about 90% of adults over age 45 and gradually reduces the ability to focus on near objects. Unlike cholinergic agonist drops, which induce miosis through the iris sphincter muscle, Ryzumvi reduces pupil size by blocking alpha-adrenergic receptors on the iris dilator muscle without engaging the ciliary muscle. The smaller pupil increases depth of focus, improving near vision while preserving distance vision.

The approval was supported by the phase 3 VEGA-2 and VEGA-3 clinical trials, which met their primary and all key secondary efficacy endpoints. At day 8, about 23% to 27% of patients treated with Ryzumvi achieved at least a 3-line improvement in near vision without loss of distance vision, compared with about 11% to 12% of patients receiving placebo. No treatment-related serious adverse events were reported.

Ryzumvi is administered as a preservative-free topical eye drop. The most common adverse reactions reported in patients treated for presbyopia were conjunctival hyperemia (21%) and instillation-site irritation (16%). Ryzumvi is not recommended in patients with active ocular inflammation such as iritis. Patients who wear contact lenses should remove them before dosing and wait 10 minutes before reinsertion.

Presbyopia care has traditionally centered on optical correction, with prescription eye drops a more recent addition. Ryzumvi gives clinicians another pharmacologic option with a distinct mechanism.

Source: Opus Genetics. (2026 Oct 16). Opus Genetics announces FDA approval of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia