The FDA has approved Allergan's, an AbbVie (ABBV) company, 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, the company specified.
VUITY is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.
""We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia," Michael Severino, MD, Abbvie vice chairman and president said.
The FDA approval of VUITY is 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.
Both studies saw statistical significance in improvement of at least three lines in near vision in low light conditions without losing more than one line of distance vision on day 30 at hour 3.
There were no serious adverse events observed in these trials and the most common adverse events occurring at a frequency of >5% were headache and eye redness, the company noted.
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