Allergan Submits New Drug Application for Investigational Eye Drop for the Treatment of Presbyopia
Allergan announced that it has submitted a new drug application to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.
The NDA is based primarily on data from two phase 3 GEMINI 1 and GEMINI 2 clinical studies, which evaluated the efficacy, safety and tolerability of AGN-190584 (pilocarpine 1.25%).
“If approved, this is expected to be the first eye drop for the treatment of presbyopia by the FDA. It’s a huge opportunity with over 128 Americans suffering from presbyopia,” George O. Waring IV, MD, FACS, lead investigator for the GEMINI 1 and GEMINI 2 studies, said in an interview with Eyewire News. “This could serve to be a gateway therapy and as an alternative or complement to glasses and contact lenses for loss of reading vision in a non-surgical way.”
In the GEMINI studies, a total of 750 patients were randomized in a one-to-one ratio of vehicle (placebo) to AGN-190584. In both studies, AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision in mesopic (in low light) conditions without a loss of distance vision vs. the vehicle. There were no treatment emergent serious adverse events observed in any AGN190584 treated participants. The most common treatment emergent non-serious adverse events occurring at a frequency of ≥5% in AGN-190584 treated participants were headache and conjunctival hyperemia.
The phase 3 GEMINI 1 and GEMINI 2 topline results were previously announced in October 2020, and additional details of these studies will be presented at upcoming medical meetings this year.
“A lot of people don’t understand what’s going on when they start to lose their reading vision and they don’t know the term ‘presbyopia.’ They don’t know this is a natural aging process of lens dysfunction,” said Dr. Waring, who is also founder and Medical Director, Waring Vision Institute, Mount Pleasant, South Carolina. “Not only is it a wonderful opportunity to educate the community, but eye care providers are going to now have a non-surgical alternative and complement to glasses and contact lenses to help with reading vision and the treatment of presbyopia.”