AbbVie has revealed new data for its investigational treatment for presbyopia – a common and progressive eye condition.
The new data includes full results from the phase 3 GEMINI 1 clinical trial, evaluating the efficacy and safety of AGN-190584 (pilocarpine 1.25%) for presbyopia.
The GEMINI 1 study evaluated 323 participants who were randomised in a one-to-one ratio to receive either placebo or AGN-190584.
The study met its primary and key secondary endpoints, with significantly more AGN-190584-treated patients gaining three lines or more in mesopic (low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at day 30.
AGN-190584 also had a rapid onset of 15 minutes and duration of up to six hours in mesopic DCNVA without loss of distance vision after administration at day 30.
Additional endpoints also showed that 75% of patients treated with AGN-190584 achieved a ≥2-line improvement in mesopic DCNVA, while 93% of participants also achieved ≥20/40 vision in photopic (daylight) DCNVA.
Further improvements in Distance Corrected Intermediate Visual Acuity (DCIVA) were also observed for up to ten hours at day 30 for AGN-190584-treated participants.
AbbVie also said patient-reported outcomes – presented at the American Society of Cataract and Refractive Surgery annual meeting – showed patients who received AGN-190584 versus placebo reported clinically meaningful and statistically significant greater improvement in ability and satisfaction, relating to near-vision reading.
Participants also reported reduction in the use of presbyopia coping mechanisms during the last seven days of the trial when treated with AGN-190584.
“If approved by the FDA, AGN-190584 is expected to be the first eye drop specifically designed for presbyopia,” said Michael Robinson, vice president, global therapeutic area head, eye care, AbbVie.
“We are pleased with the favourable safety and efficacy results, as well as the rapid onset and duration of improvement in near and intermediate vision without impacting distance vision, from the phase 3 GEMINI 1 clinical study,” he added.
AGN-190584 is an investigational eye drop instilled in both eyes and administered once daily. Its mechanism of action is through pupil constriction to enhance depth of focus and improve near and immediate vision, while maintaining pupillary response to different lighting conditions.
Currently, a new drug application (NDA) for the treatment is under review with the US Food and Drug Administration, with a decision expected by the end of 2021.