Corrective lenses for presbyopia have a new competitor to contend with. The first drug for such use—Vuity, from Allergan—was approved today by the FDA.
The pupil-constricting drop (pilocarpine 1.25%) reaches peak efficacy one hour after instillation, but some patients experienced notable improvement in as little as 15 minutes and positive effects on vision can last up to six hours, Allergan says. Dosing is QD.
Its two Phase III trials (Gemini 1 and 2) used a primary endpoint of achieving three lines of near vision improvement under mesopic conditions without losing more than one line of distance vision, when measured at day 30, hour 3, of use. This was met by 31% and 26% of subjects, respectively, in the two studies. Both groups showed statistically significant improvement over placebo, a press release notes.
Headache and conjunctival hyperemia were the most common adverse events reported. The company says the drug’s vehicle is formulated to adapt to the pH of the eye to reduce blur and discomfort.
Additional data on Vuity’s performance will be presented next week in Boston at the Academy 2021, according to Allergan.