FDA approves Vuity for presbyopia – Allergan / AbbVie
Allergan announced the 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 that affects 128 million Americans, nearly half of the U.S. adult population.
The FDA approval of Vuity is based on data from two pivotal phase III clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of Vuity for the treatment of presbyopia. 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 study. The most common adverse events occurring at a frequency of greaterthan 5% were headache and eye redness.