Allergan’s Vuity (pilocarpine HCl ophthalmic solution 1.25%) received FDA approval for the treatment of presbyopia.

Vuity is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to six hours to improve near and intermediate vision without impacting distance vision, the company says. It is delivered via pHast technology, which enables it to rapidly adjust to the physiologic pH of the tear film, Allergan says.

FDA approval was based on two Phase 3 studies, GEMINI 1 and GEMINI 2, which assessed the efficacy, safety and tolerability of the drop. In both studies, Vuity met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions sans a loss of distance vision vs. the vehicle (placebo) on day 30 at hour 3. No serious adverse events were observed in Vuity-using participants in either study. The most common adverse events, occurring at a frequency of >5%, were headache and eye redness. OM