An once-daily eye drop that temporarily corrects late-life vision loss, or presbyopia, has had success in a late-stage clinical trial, drugmaker Allergan has announced.
Presbyopia is a common, and progressive eye condition. It reduces the eye’s ability to focus on near objects and affects the majority of adults over the age of 50. Allergan’s investigational eye drop, pilocarpine (AGN-190584), contracts the pupil to an optimal pupil size range, enhancing near vision with no effect on distance vision, according to the company.
Trial participants received a 1.25% formulation of the drug in both eyes, once daily, for 30 days. When compared to placebo, they reported significant near-vision improvements, under low-light conditions, and without losing distance vision, Allergan reported at a presentation last week at the Association for Research in Vision and Ophthalmology (ARVO) 2021 conference.
Effects are seen as early as 15 minutes after applying the drop and last for about six hours, the company said.
Investigators measured better visual reading performance and satisfaction. Participants self-reported a reduced need for coping mechanisms, such as squinting to read, increasing font size when reading, holding reading materials away from the face, and relying on others for assistance with near-vision-related activities.
Allergan in February applied for approval to bring the eye drop, pilocarpine (AGN-190584), to market. It expects a response from the Food and Drug Administration by the end of the year, according to Michael R. Robinson, M.D., vice president, global therapeutic area head, eye care, AbbVie, Allergan’s parent company.
If approved, it is expected to be the first and only FDA-approved eye drop to treat presbyopia and improve blurry near vision, Robinson said.
The drug “may be a great first-line option for people who don’t currently have a solution and an alternative or complementary choice for those already using reading glasses and contact lenses who desire more flexibility and convenience,” he said.