The US Food and Drug Administration (FDA) has approved Opus Genetic’s supplemental new drug application for phentolamine ophthalmic solution 0.75% (Ryzumvi) for the treatment of presbyopia in adults, expanding the drug’s previously approved indication for reversing pharmacologically induced mydriasis.

Ryzumvi is an alpha-adrenergic antagonist that reduces pupil diameter by inhibiting contraction of the iris dilator muscle. The resulting smaller pupil increases depth of focus, providing an approach to improving near vision without directly stimulating accommodation. The expanded indication adds another pharmacologic option for managing age-related near vision impairment.

The approval follows clinical evaluation of phentolamine ophthalmic solution in patients who have presbyopia. The treatment is intended to improve near visual acuity while preserving distance vision.

The drug’s previously approved labeling identifies ocular inflammation as a precaution and instructs patients to remove contact lenses before administration. Practitioners should consult the updated FDA-approved prescribing information for dosing instructions, adverse reactions, and contact lens precautions specific to the presbyopia indication.