The United States Food and Drug Administration has approved the first and only eye drops capable of treating age-related blurred “near vision”.
The new ophthalmic solution called Vuity treats presbyopia and is now available by prescription at pharmacies nationwide.
Presbyopia can be diagnosed by a basic eye exam performed by an ophthalmologist (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the adult American population.
“We are excited to be able to market this one-of-a-kind treatment sooner than expected to the millions of presbyopic Americans who could benefit from it,” said Jag Dosanjh, senior vice president of Allergan, an AbbVie. business.
“Many Americans treat presbyopia, which typically begins around age 40, by using reading glasses or by resorting to workarounds, such as zooming in on their digital devices to see up close. As an optometrist who also suffers from presbyopia, I am personally and professionally delighted to try Vuity for myself, as well as to offer it to my patients with age-related blurred near vision, ”said optometrist Dr. Selina McGee, member of the American Academy. of Optometry.
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Vuity is an optimized formulation of pilocarpine, an established eye care therapy provided with proprietary pHast technology, which allows gout to quickly adapt to the physiological pH of the tear film. This has been studied in a simulated tear film, and the clinical significance is unknown. Vuity uses the eye’s own ability to reduce pupil size, thereby improving near and intermediate vision while maintaining distance vision.
Vuity’s approval by the FDA in October 2021 was based on data from two pivotal Phase 3 clinical studies, which assessed the efficacy, safety and tolerability of VUITY using a total of 750 participants aged 40 at age 55 with presbyopia, randomized in the two studies. in a one-to-one ratio to Vuity or a placebo.
One of the trial participants, Toni Wright, said: “It has become almost impossible to see clearly up close unless I’m wearing my readers. I am so excited that this is now approved and available as a treatment.
Participants were required to administer one drop of VUITY or a 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 board) or more in mesopic (low light), high contrast , binocular Corrected distance for near vision Visual acuity, without losing more than one line (5 letters) of corrected distance visual acuity on day 30, hour 3, versus placebo.
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The new drug takes effect in about 15 minutes, with one drop in each eye providing sharper vision for six to 10 hours, according to the company. The drops are intended for mild to intermediate cases and are less effective after age 65, as the eyes age. Users may also have temporary difficulty adjusting the focus between near and far objects.
No serious adverse events were observed in participants treated with VUITY in any of the clinical studies. The most common side effects occurring at a frequency> 5% were mild headaches and redness of the eyes, the company reports in a statement.
Usually not covered by health or eye insurance, it costs between $ 76 and $ 86 for a 30-day supply, depending on your pharmacy.
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Talk to your eye doctor (ophthalmologist or optometrist) for more information on obtaining a prescription, and learn more at www.vuity.com.