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The Food and Drug Administration has given the green light to Vuity 1.25%, the first approved prescription eye drops to treat age-related blurry near vision.
Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an optometrist or ophthalmologist and is a common and progressive condition that affects 128 million Americans, or nearly half of the U.S. adult population. In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on close objects.
Americans typically start experiencing presbyopia around age 40 and deal with the condition by relying on reading glasses or zooming in on their digital devices to see up close.
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Vuity is an optimized formulation of eye care therapeutic pilocarpine that uses the eye's own ability to reduce pupil size to improve near and intermediate vision while maintaining distance vision.
The Food and Drug Administration has given the green light to Vuity 1.25%, the first approved prescription, once-daily eye drops to treat age-related blurry near vision. (Allergan)
The drops, which should be used once daily in each eye, work in as early as 15 minutes and provide up to six hours of sharper vision. Vuity, which is developed by Allergan, an AbbVie company, is available by prescription now at pharmacies nationwide. A Vuity spokesperson confirmed to FOX Business that a 30-day supply of the drops costs around $80.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| ABBV | ABBVIE INC. | 125.23 | +1.16 | +0.93% |
"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," Allergan senior vice president of medical therapeutics, Jag Dosanjh, said in a statement. "This significant innovation in age-related eye health reflects our commitment to advance vision care and expands our leading portfolio of treatments for eye care providers and their patients."
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The FDA approval comes after 750 adults with presbyopia between the ages 40 to 55 years old were placed randomly in two clinical studies, dubbed GEMINI 1 and GEMINI 2, in which one group received Vuity and the other received a placebo.
The studies found that a statistically significant portion of participants treated with Vuity gained the ability to read three or more additional lines on a reading chart in a low light setting with near vision without losing more than 1 line with distance vision at day 30, 3 hours after dosing. There were no serious adverse events observed in any participants treated with Vuity in either clinical study. The most common side effects were headache and eye redness.
Patients who use Vuity should use caution when driving at night or performing hazardous activities in poor lighting and should not drive or use machinery if their vision is not clear. Temporary problems when changing focus between near and distant objects may occur.
Individuals who wear contact lenses should remove them prior to using Vuity and wait 10 minutes after dosing before reinserting them. If more than one topical eye medication is being used, they must be administered at least five minutes apart.
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