The first-ever eye drop approved by the U.S. Food and Drug Administration to combat symptoms of presbyopia, or age-related blurry near vision, is now available by prescription nationwide.
Pharmaceutical company Allergan, owned by AbbVie, announced the development on Dec. 9. The company says its eye drops, “Vuity,” or pilocarpine hydrochloride ophthalmic solution 1.25 percent, is now the only FDA-approved eye drop to manage presbyopia symptoms.
The FDA approved Vuity on Oct. 28.
Presbyopia is an age-related progressive condition that typically starts around age 40. In presbyopia, the lens behind the iris becomes progressively less able to change shape, which affects the eyes’ ability to focus on closer objects.
The eye drop combats symptoms of presbyopia by improving vision at near and intermediate distances, without impacting distance vision, Allergan said in its release. Vuity is intended to be taken daily and is expected to take effect within 15 minutes and last up to six hours.
Pilocarpine acts to constrict the size of the pupils, thereby creating a pinhole effect that increases the depth of focus and improves a person’s ability to focus on near objects.
The eye drop “is delivered with proprietary pHast™ technology, which allows Vuity to rapidly adjust to the physiologic pH of the tear film,” Allergan said.
The pHast™ drug delivery platform vehicle is “expected to improve patient comfort, cause less blur, and provide a well-tolerated alternative to currently available ocular pilocarpine medications,” Abbvie authors said in a paper presented at the American Association of Pharmaceutical Scientists 2020 Annual Meeting and Exposition.
$79 for 30-Day Supply
An AbbVie spokesperson said that Vuity will cost $79 for a 30-day supply (a 2.5 milliliter bottle) for many patients, but the cost may vary depending on the pharmacy or insurance coverage, reported CNET.
The FDA approval was based on data from two phase 3 clinical studies, GEMINI 1 and GEMINI 2, which involved a total of 750 people aged 40–55 with presbyopia. Compared to the placebo group, those who took Vuity gained at least three additional lines on a near reading chart without losing more than one line of vision at distance by day 30.
There were no serious adverse events by day 30 in either study. The most common adverse events noted in over 5 percent of the participants who took the eye drop were headaches and eye redness.
Pilocarpine in the ophthalmic setting has long been used to treat acute angle closure glaucoma and previously other forms of glaucoma, although now it is not typically used in long-term management due to side effects.
It is unclear, therefore, how the newly approved Vuity drops would fare if taken long term.
“This is something that we anticipate will be well-tolerated long term, but this will be evaluated and studied in a formal capacity,” George O. Waring, principal study investigator for GEMINI 1 and GEMINI 2, told CBS News.
He said in a separate statement on Oct. 29 that Vuity “offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision” for mild to intermediate cases.
Allergan advises people taking the drops to “[u]se caution with night driving or with hazardous activities performed in low light conditions,” and to “not drive or use machinery if vision is not clear” because they may have temporary problems in changing focus between near and distance.
Some notable contraindications for pilocarpine include allergy to the drug, uncontrolled asthma, and when constricted pupils are not wanted such as in uveitis or secondary glaucoma.