AbbVie Submits First NDA for Novel Eye Drop to Treat Presbyopia

On February 25, AbbVie/Allergan announced that it had submitted a New Drug Application (NDA) to the U.S. FDA for AGN-190584 (1.25% pilocarpine ophthalmic solution) for the treatment of presbyopia. The FDA is expected to make an approval decision by the end of 2021.

Presbyopia is a common, progressive eye condition that impairs the eye’s ability to focus on near objects and typically affects individuals over the age of 40. However, public awareness of presbyopia remains relatively low compared to other ophthalmic diseases. There are approximately 128 million people with presbyopia in the United States.

AbbVie’s application is primarily based on the results of two Phase III studies, codenamed GEMINI 1 and GEMINI 2. These studies evaluated the efficacy, safety, and tolerability of AGN-190584 (1.25% pilocarpine ophthalmic solution) in a total of 750 patients, who were randomized in a 1:1 ratio to receive either AGN-190584 or placebo. Both studies met their primary endpoints, demonstrating that AGN-190584 significantly improved near vision under dim light conditions compared with placebo, without causing a decline in distance visual acuity. Among subjects treated with AGN-190584, the most common (≥5%) treatment-emergent non-serious adverse events were headache and conjunctival hyperemia; no treatment-related serious adverse events were reported. Detailed study data will be presented at an upcoming medical conference.

AGN-190584 is a novel, improved formulation of pilocarpine (a cholinergic muscarinic receptor agonist), developed as a once-daily eye drop for the treatment of presbyopia. AGN-190584 activates muscarinic receptors in smooth muscles, such as the iris sphincter and ciliary muscle. By inducing contraction of the iris sphincter, it causes miosis, thereby increasing depth of focus and improving near and intermediate vision while maintaining pupillary light reflex. Additionally, AGN-190584 contracts the ciliary muscle, enhancing accommodative amplitude.

According to survey results from 1,399 middle-aged adults aged 40–55 in the United States, 90% of respondents are significantly affected by presbyopia. Tom Hudson, Senior Vice President of Research and Development at AbbVie and MD, stated, “Presbyopia affects most adults over the age of 40. Current treatment options are generally inconvenient or invasive, such as using reading glasses or wearing contact lenses. If AGN-190584 is approved, it will be the first eye drop medication for the treatment of presbyopia, providing a new therapeutic option for patients in the United States.”

Currently, there are no approved therapeutic drugs specifically for presbyopia worldwide, with three investigational drugs in Phase III clinical trials. On August 11 last year, Jimu Biology acquired the development rights for MicroPine (atropine ophthalmic solution), an innovative myopia treatment, and MicroLine (pilocarpine ophthalmic solution), an innovative presbyopia treatment, from Eyenovia Inc. of the United States for USD 47.5 million, covering Greater China and South Korea.