A new drug that could help more than 128 million Americans read without needing glasses has been submitted to the federal Food and Drug Administration for approval.
The eye drop — called AGN-190584 — is expected to be approved by the end of this year, according to Allergan Eye Care, which is owned by AbbVie.
The eye drops are a pilocarpine solution meant to treat the symptoms of presbyopia, an age-related condition that causes gradual loss of the eyes’ ability to focus on nearby objects.
It’s a natural but annoying part of aging, said Dr. Robert S. Bailey, chief of the Cataract and Primary Eye Care Service at Wills Eye Hospital in Philadelphia.
“It happens from 10, and then you gradually lose that focusing ability to the age of 70, when you lose the ability totally,” Bailey said, with most people starting to notice it in their mid-40s.
Presbyopia is caused by the loss of elasticity in the eyes’ lens, which makes it harder to change shape when it needs to shift focus from faraway objects to closer ones.
The drops don’t treat the cause of presbyopia. They help treat its symptoms. Instead of targeting the eyes’ lens, the drops make the eyes’ pupils smaller, creating a pinhole effect that increases the depth of focus.
“If you have a camera and you make the aperture small, let little light in, the depth of focus — or the distance over which things are in focus — are much greater than if you open up the camera,” Bailey said. “It gives you greater depth of focus not just far away but closer as well.”
The application for the new drug is based on two randomized trials of 750 participants ages 40 to 55 in which they were treated either with the drug or with a placebo once a day for 30 days.
The studies found the eye drops were safe and effective, with participants gaining three more lines on the reading chart in low light compared with those who got the placebo, according to trial results published by the company last October. The eye drops began working as soon as 15 minutes after they were applied and reached their peak effectiveness after about an hour, according to Allergan.
Side effects that occurred in fewer than 5% of patients included headache, red eyes, blurred vision and some eye pain.
If approved by the FDA, AGN-190584 would be the first eye drop that treats presbyopia. Pilocarpine eye drops have already been approved at a higher concentration for glaucoma patients, who use it about four times a day at 4% concentration. Presbyopia patients might use it only once a day or on demand at 1.25%, said Dr. Michael Robinson, vice president and global therapeutic area head for AbbVie. Future trials will look at how the drug works when used more than once a day, according to Robinson.
“In glaucoma, it improves the outflow of fluid from the eye, and that lowers the intraocular pressure,” he said. “We’re using pilocarpine to basically constrict the pupil.”
That could make driving at night dangerous, but the FDA would determine what has to go on warning labels if the drug is approved, Robinson said. Other warnings could include exercising caution while operating heavy machinery, especially in poor light.
The target population is people with mild to moderate presbyopia in their 40s and 50s. But Robinson said the company is planning trials to study the drug in older patients. He doesn’t see the eye drops replacing reading glasses but instead could be another tool.
“Presbyopia is a frustrating thing for many people in terms of needing reading glasses,” Bailey said. “This is one way of potentially dealing with that.”
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