Newly Approved Eye Drops Could Replace Reading Glasses for 128 Million Americans

Approximately 128 million Americans may be able to ditch reading glasses thanks to newly approved eye drops.

On December 9, pharmaceutical manufacturer Allergan unveiled its VUITY (pilocarpine HCl ophthalmic solution) 1.25 percent eye drops that were approved by the U.S. Food and Drug Administration in October. The drops treat presbyopia, or age-related blurry near vision, that affects about half of the U.S. population.

The term "presbyopia" comes from a Greek word meaning "old eye." The American Academy of Ophthalmology (AAO) calls it a normal part of aging.

Humans have a clear lens inside the eye, behind the colored iris, that changes shape to focus light onto the retina so vision occurs. The AAO said the condition occurs when the eye lens becomes more rigid and has difficulty changing shape. Younger individuals possess a lens that is more soft and flexible.

Presbyopia cannot be reversed and is often corrected by the use of eyeglasses, contacts or surgery. If left uncorrected, headaches and eye strain could become more routine, according to the AAO.

The condition can be diagnosed by an optometrist or ophthalmologist via a basic eye exam. The newly-approved eye drops are currently available by prescription in nationwide pharmacies.

"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, senior vice president of medical therapeutics of Allergan. "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."

Presbyopia usually begins around age 40, said Dr. Selina McGee, Fellow of the American Academy of Optometry. Currently, individuals plagued by blurry near vision normally rely on reading glasses as a remedy. In some cases, people simply magnify words or images—such as on mobile devices—to see better.

The FDA approved VUITY based on data from two phase 3 clinical studies that evaluated the efficacy, safety and tolerability of the product for treatment.
A total of 750 participants aged 40 to 55 years with presbyopia were randomized in the two studies, each presented with VUITY or a placebo. All participants were instructed to administer one drop of VUITY or the placebo once daily into each eye.

Those who administered VUITY were provided "a statistically significant" advantage, according to Allergan, as those participants gained the ability to read three additional lines on a reading chart; read better in low light; or in "high contrast, binocular Distance Corrected Near Visual Acuity [DCNVA], without losing more than one line [five letters] of Corrected Distance Visual Acuity [CDVA] at day 30, hour 3, versus placebo."

Most participants experienced no serious adverse effects, the company added. The most common reactions occurred in less than 5 percent of subjects, notably headaches and eye redness.

Allergan stated that clinical studies of VUITY did not include subjects aged 65 years or older to determine response compared to younger subjects.