FDA Approves Therapy for Age-Related Blurry Vision

Vuity, developed by Allergan, is a once-daily eye drop to treat presbyopia.

The FDA has approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of adults with presbyopia, age-related blurry near vision. This is the only FDA-approved eye drop to treat this progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. Vuity was developed by Allergan, an AbbVie company.

“As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. Vuity offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” George O. Waring IV, M.D., medical director, Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator, said in a statement. "I am particularly encouraged by the rapid onset of action and duration of efficacy for Vuity to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia."

Vuity is a daily, prescription eye drop that works in as little as 15 minutes and lasts up to 6 hours to improve near and intermediate vision without impacting distance vision. Specifically designed for presbyopia, Vuity uses a proprietary technology allows the therapy to rapidly adjust to the physiologic pH of the tear film. It uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.

The FDA approval is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2. A total of 750 participants aged 40 to 55 years old with presbyopia were randomized to either Vuity or placebo.

In both studies, Vuity met the primary endpoint of improvement in near vision in low light conditions without a loss of distance vision versus the vehicle on day 30 at hour three. There were no serious adverse events in either the GEMINI 1 or GEMINI 2 study. The most common adverse events occurring were headache and eye redness.