Allergan, an AbbVie company, announced the FDA approval of the eye drop, Vuity, for the treatment of presbyopia.
The approval for the pilocarpine HCl ophthalmic solution 1.25% was granted Oct. 28, according to the FDA’s website.
“”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 in a press release from the company.
This daily prescription eye drop takes effect in as little as 15 minutes and can last up to 6 hours, the company said in the release, improving near and intermediate vision without affecting distance vision.
The pilocarpine is delivered with pHast technology, which allows the solution to rapidly adjust to the tear film’s pH, according to the release.
The company said the FDA approval is based on data from two phase 3 clinical studies, GEMINI 1 and GEMINI 2. 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.
No serious adverse events were seen in either study. The most common were headache and ocular redness in more than 5% of subjects.
PERSPECTIVE
Approval of Allergan’s Vuity eye drop for treating presbyopia ushers in a new era of pharmaceutical treatments for refractive error. With several other presbyopia drops in trials, clinicians will soon have choices for helping patients avoid reading glasses. Furthermore, several drops are also seeking approval for halting progressive myopia in young patients. No longer are corrective lenses and surgery the only choices for improving eyesight.
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