Allergan announced the phase 3 GEMINI 1 and 2 clinical trials evaluating the efficacy, safety, and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia, met their primary efficacy endpoint.
In GEMINI 1, the primary endpoint was met with a statistically significant greater proportion of participants treated with AGN-190584 who gained 3 lines or more in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 versus the vehicle (placebo). In GEMINI 2, the primary endpoint was also met with a statistically significant greater proportion of participants treated with AGN-190584 who gained three lines or more in mesopic, high contrast, binocular DCNVA without loss of greater than five letters in Corrected Distance Visual Acuity (CDVA) with the same refraction at Day 30, Hour 3 versus the vehicle.
Additional details of these studies will be presented at future medical meetings and will serve as the basis for the new drug application submission to the FDA in the first half of 2021.
“Presbyopia symptoms can significantly disrupt everyday activities like reading, using a smartphone, working, and cooking,” George O. Waring IV, MD, FACS, medical director, Waring Vision Institute, South Carolina, said in a company news release. “While individuals currently have several options to help manage presbyopia, including glasses, contact lenses and surgery, research has shown that the majority of presbyopic individuals are frustrated with the use of contact lenses or glasses. These GEMINI findings support the possibility of another treatment option for people living with presbyopia.”
In a non-presbyopic eye, the clear lens behind the iris can change shape and focus light to the retina, making it easier to see things up close. In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects. AGN-190584 is an investigational eye drop designed to treat symptoms of presbyopia and is instilled in both eyes.
“Our research shows that the symptoms associated with presbyopia can significantly impact people’s daily lives,” Michael R. Robinson, MD, vice president, global therapeutic area head, ophthalmology, AbbVie, said in the news release. “The positive results from the GEMINI studies show the potential of this investigational optimized formulation of pilocarpine 1.25% to treat symptoms associated with presbyopia.”
Read the full press release here.