The U.S. Food and Drug Administration has approved the first and only eye drop that can treat age-related blurry ‘near vision’.
The new ophthalmic solution called Vuity treats presbyopia, and is now available by prescription in pharmacies nationwide.
Presbyopia can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population.
“We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,” said Jag Dosanjh, a senior vice president for Allergan, an AbbVie company.
“Many Americans deal with presbyopia, which typically begins around age 40, by relying on reading glasses or resorting to work-arounds like zooming in on their digital devices to see up close. As an optometrist who also has presbyopia, I’m personally and professionally excited to try Vuity for myself, as well as offer it to my patients with age-related blurry near vision,” said optometrist Dr. Selina McGee, Fellow of the American Academy of Optometry.
Vuity is an optimized formulation of pilocarpine, an established eye care therapeutic delivered with proprietary pHast technology, which allows the drop to rapidly adjust to the physiologic pH of the tear film. This was studied in simulated tear film, and the clinical significance is unknown. Vuity uses the eye’s own ability to reduce pupil size, improving near and intermediate vision while maintaining distance vision.
The FDA approval of Vuity in October 2021 was based on data from two pivotal phase 3 clinical studies, which evaluated the efficacy, safety and tolerability of VUITY using a total of 750 participants aged 40 to 55 years old with presbyopia, randomized in the two studies in a one-to-one ratio to either Vuity or placebo.
One of the trial participants, Toni Wright, said, “It has become almost impossible to see clearly up close unless I wear my readers. I’m so excited this has now been approved and available as a treatment.”
Participants were instructed to administer one drop of VUITY or placebo once daily in each eye.
Both studies met their primary endpoints with a statistically significant proportion of participants treated with Vuity gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity, without losing more than 1 line (5 letters) of Corrected Distance Visual Acuity at day 30, hour 3, versus placebo.
The new medicine takes effect in about 15 minutes, with one drop on each eye providing sharper vision for six to 10 hours, according to the company. The drops are for mild to intermediate cases and are less effective after age 65, as eyes age. Users may also have temporary difficulty in adjusting focus between objects near and far.
There were no serious adverse events observed in any participants treated with VUITY in either clinical study. The most common side effects occurring at a frequency of >5% were mild headaches and eye redness, reports the company in a statement.
Not typically covered by health or vision insurance, it costs around $76-$86 for a 30-day supply, depending on your pharmacy.