FDA Approves Allergan/AbbVie’s Vuity (pilocarpine HCl) Making it the First and Only Eye Drop for Treating Presbyopia

Allergan, an AbbVie company, announced the U.S. FDA approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition.

The FDA approval of Vuity was based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of Vuity for the treatment of presbyopia. A total of 750 participants aged 40 to 55 years old with presbyopia were randomized in the two studies in a one-to-one ratio of placebo to Vuity. Participants were instructed to administer one drop of Vuity or placebo once daily in each eye. In both studies, Vuity met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision versus the vehicle (placebo) on day 30 at hour 3. Additionally, improvement was seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events observed in participants receiving VUITY in either the GEMINI 1 or GEMINI 2 stu...

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