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Credit: https://trialsitenews.com/allergan-announces-positive-data-from-phase-3-gemini-trials-evaluating-agn-190584-for-presbyopia/
New drug could see millions of americans trade in their reading glasses for eye drops
March 18, 2021
- A new drug could see millions eventually trade in their reading glasses for eye drops.
- If approved, the drug in question will become the first viable treatment for presbyopia in the market.
- Presbyopia is an age-related condition that results in the steady loss of the eyes’ ability to focus on up-close and nearby objects.
A new drug— which could finally see more than 128 million Americans read perfectly without requiring their glasses—has been submitted to the FDA for impending approval.
The eye drops, which go by the name AGN-190584, could see approval by the end of 2021. This is according to a statement released a couple of days ago by Allergan Eye Care.
The eye drops are a pilocarpine solution geared towards treating the symptoms of presbyopia—an age-related condition which results in the steady loss of the eyes’ ability to focus on nearby or up-close objects.
According to Dr. Robert S. Bailey, chief of the Cataract and Primary Eye Care Service at Wills Eye Hospital in Philadelphia, the phenomenon is a natural but inconvenient part of the aging process. It can begin as early as the age of 10, when you naturally begin to lose the ability to focus, all the way to the age of 70—when you can lose that focus completely. For most patients, they only begin to notice their loss in focus when they reach their mid-40s.
Presbyopia occurs when there is loss of elasticity in the eyes’ lens—making it difficult for the eye to change shape when it is required to shift focus from distance objects to much closer ones.
The eye drops don’t actually treat the underlying cause of presbyopia, but only handle the symptoms of the degenerative disorder. In fact, instead of targeting the eyes’ lens, the solution works by making the eyes’ pupils smaller; creating a pinhole effect that increases the depth of focus.
The application of the new drugs comes after two randomized trials carried out on 750 participants aged between 40 to 55 years whereby patients were treated either with the drug or with a placebo once a day, for 30 days straight.
During the study, researchers found that the eye drops were deemed effective and safe, with participants gaining three more lines in their reading chart in low light as compared to those who took the placebo.
According to trial results that were published by the company in October of 2020, the eye drops became effective 15 minutes after application but reached peak effectiveness roughly an hour after application. Some of the side effects experienced by roughly 5% of the patients included blurred vision, eye pain, red eyes, and headaches.
If approved, the drug will become the first ever eye drop in the market that treats presbyopia.
Nevertheless, pilocarpine eye drops at a higher concentration have been released for the treatment of patients with glaucoma.
While the higher concentration of pilocarpine solution (4%) is used to improve the outflow of fluid in the eye to lower intraocular pressure in glaucoma, the concentration in presbyopia (1.25%) is used to primarily constrict the pupil.
As such, this could make driving at night quite dangerous. However, if it comes to that, then the FDA will have to determine whether warning labels will be required on caps once the drug is approved.
Other warnings that could be put on the drug include exercising caution when handling heavy machinery, especially in bad lighting.
While the company is targeting patients that exhibit mild presbyopia in their mid 40s and 50s, the company is also looking to see if they can target older patients.
For now, the solution might not be a complete replacement for reading glasses, but it could potentially be a feasible solution to reading glasses in the near future.
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