Fda Eye Drops Reading Glasses

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Fda Eye Drops Reading Glasses
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The new ophthalmic solution called Vuity treats presbyopia, and is now available by prescription in pharmacies nationwide.

New Eye Drops Offer an Alternative to Reading Glasses

Vuity, a once-a-day treatment that can help users see up close without affecting their long-range vision, went on the market Thursday after being approved by the F.D.A. in October.

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Fda Eye Drops Reading Glasses

By Melinda Wenner Moyer

Published Dec. 14, 2021 Updated Feb. 2, 2022

An eye drop that improves close-range vision could make misplaced reading glasses less of an inconvenience for many of the 128 million Americans who suffer from age-related deficits in near vision. Vuity, which became available by prescription on Thursday, is a once-a-day treatment that can help users see up close without affecting their long-range vision.

“For anybody who doesn’t want to fiddle with reading glasses, this might be a really helpful alternative,” said Dr. Scott M. MacRae, an ophthalmologist at the University of Rochester’s Center for Visual Science. Dr. MacRae was not involved in the clinical trials for the drug, which was approved by the U.S. Food and Drug Administration in late October.

Nearly 90 percent of U.S. adults over 45 have problems with close-range vision, a condition known as presbyopia that typically worsens over time. To focus on close objects, the eye’s lens must change shape, yet it becomes less flexible as people age, making this process difficult. “Your ability to zoom in decreases,” Dr. MacRae said.

People who suffer from presbyopia often find they need to hold a book at arm’s length or turn on a bright light to read it, said Dr. George O. Waring IV, an ophthalmologist and the medical director of the Waring Vision Institute in Mt. Pleasant, S.C., who led Vuity’s clinical trials for the pharmaceutical company Allergan. Typically, eye doctors recommend that people with presbyopia wear over-the-counter or prescription reading glasses when they need to see up close, but Vuity may also be an option for them, he said.

Vuity improves near vision by constricting the size of the pupil. “It makes the pupil small, creating what we call a pinhole effect,” that way reducing the amount of peripheral light that passes through the eye that can make it hard to focus, said Dr. Stephen Orlin, an ophthalmologist at the University of Pennsylvania Perelman School of Medicine.

Vuity’s active ingredient is a drug called pilocarpine, and it is not a new medication. It’s actually “one of the oldest drops that we have in ophthalmology,” Dr. Orlin said. It has been used for decades to treat glaucoma, a condition characterized by damage to the optic nerve. Although Vuity is the first product of its kind to treat presbyopia, at least nine similar eye drop products are in clinical development to treat presbyopia and may be available in the future, Dr. Waring said.

Dr. Waring and his colleagues presented the results of their Phase 3 clinical trials, which have not yet been published in a peer-reviewed journal, at the 2021 annual meeting of the American Society of Cataract and Refractive Surgery in July. A single Vuity drop in each eye improved trial subjects’ close-range vision for six hours and improved their intermediate vision — important for computer work — for 10 hours.

Vuity’s benefit over reading glasses is that it does not impair distance vision like reading glasses do. Usually, when a person stops reading to do something else, they need to remove their reading glasses to see around them properly. “That’s the good part about this — the drops don’t really affect distance vision under normal daylight conditions,” Dr. MacRae said.

Dr. MacRae also noted that Vuity will work best for people who have only mild to moderate presbyopia, which probably means people between the ages of 45 and 55. Older individuals with more serious presbyopia may find that the eye drops do not improve their near vision enough to make a difference.

Vuity does not correct regular nearsightedness, farsightedness or astigmatism — it improves only the age-related deficits in close-range vision. So people with other eye errors will want to continue wearing glasses or contact lenses even if they also use Vuity, Dr. MacRae noted.

And the drops are not meant to replace reading glasses entirely, Dr. Waring said. People with presbyopia will probably want to own reading glasses, too, but Vuity may reduce the amount of time they need to wear them.

“For some people, it’s going to work great,” Dr. MacRae said.

Vuity is not typically covered by health or vision insurance, and Dr. Waring said it might cost around $80 per 30-day supply.

Although the clinical trials did not report any serious side effects, 14.9 percent of subjects who took Vuity reported mild headaches, compared with 7 percent of subjects who took placebo drops. Up to 5 percent of subjects taking Vuity reported other side effects such as eye redness, blurred vision, eye pain, visual impairment, eye irritation and an increased production of tears.

Because the eye drops reduce pupil size, they also make it harder to see in the dark, so they are not recommended for people who drive at night or need to see well in low light for other reasons, Dr. Waring said.

Melinda Wenner Moyer is a science journalist and the author of “How To Raise Kids Who Aren’t Assholes.”

How FDA-Approved Eye Drops Could Replace Your Reading Glasses

Fda Eye Drops Reading Glasses

The Food and Drug Administration approved new eye drops that can potentially replace reading glasses.

The prescription medication Vuity treats age-related blurry vision, also known as presbyopia.

It’s a condition common enough to affect approximately 128 million people in the United States as the muscles in the eyes require more effort to focus.

Although the condition is common, it doesn’t mean we have to live with it.

For people tired of always looking for reading glasses or squinting their eyes trying to read a product label, a daily dose of Vuity could help.

The drops utilize the active ingredient pilocarpine, which is meant to stimulate the eyes to reduce the size of the pupil and help the eye focus.

“I have been asked about this nonstop since it came out. Everyone wants to get rid of their readers,” Dr. Yuna Rapoport, an ophthalmologist with Manhattan Eye in New York, told Healthline.

“Vuity, or the generic pilocarpine 1.25 percent, improves your new vision through the ‘pinhole effect,’ or by making the pupil smaller. It gives about 2 to 3 hours of improved near vision but does not completely reverse presbyopia or the hardening of the zones around the lens,” Yuna said.

Rapoport said the new product will be great for people in their 40s and 50s who “still have a bit of their own accommodation left.” But it may not be so great for people over 55 years old.

“For those folks, it may be enough when glancing at a dashboard or a menu for example but not enough for sustained work or reading up close for a period of time,” Rapoport said.

During clinical trials with 750 people from 40 to 55 years old with presbyopia, researchers reported that Vuity helped people read an average of 3 extra lines on an optometrist’s vision chart “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.”

“A large percentage of patients were able to improve their near vision by 3 lines or more, and the vast majority were able to achieve functional near vision of 20/40 or better,” Dr. Dagny Zhu, a an opthalmologist and medical director of NVISION Eye Centers in Rowland Heights, California, told Healthline.

“This means that many patients may be able to see well enough to read on their laptops or text messages on their cellphones without having to rely on their reading glasses as often,” Zhu said.

“However, it’s important to keep in mind that the response will vary from person to person depending on a few factors, including age and their baseline near vision,” she said.

Zhu said Vuity will work best on younger adults with mild to moderate cases of presbyopia.

“I’ve already started offering the drops to some of my own patients and have been pleasantly surprised to see a noticeable improvement in as little as 15 to 20 minutes,” said Zhu.

Which doesn’t mean there aren’t side effects, although experts say they appear to be mild.

“Vuity has a well-established safety profile,” Dr. Selina McGee, an optometrist and founder of BeSpoke Vision in Oklahoma, told Healthline.

“In clinical studies, there were no serious adverse events observed in any participants treated with Vuity. The most common adverse events occurring, at a frequency of more than 5 percent in participants, were headache and eye redness.”

“Temporary problems when changing focus between near and distant objects may occur,” McGee said. “The important safety information states to use caution when driving at night or performing hazardous activities with little lighting.”

Rapoport said the generic version, pilocarpine, “has been around for decades.”

“At a higher dose (it) is used as a pressure-lowering medication in glaucoma patients,” she said. “In higher doses, it increases risk of retinal detachments in patients who are very myopia, or nearsighted.”

Eye Drops to Replace Reading Glasses For Aging Eyes Go on Sale Following FDA Approval

Fda Eye Drops Reading Glasses

The U.S. Food and Drug Administration has approved the first and only eye drop that can treat age-related blurry ‘near vision’.

Fda Eye Drops Reading Glasses

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.