AbbVie subsidiary Allergan has reported that its experimental AGN-190584 ophthalmic solution met primary and key secondary efficacy goals in a Phase III GEMINI 1 clinical trial for presbyopia treatment.
AGN-190584 is a formulation of pilocarpine 1.25% delivered as a topical, once-daily drop.
It is designed to constrict the pupil to improve depth of focus and enhance near and intermediate vision without affecting dynamic pupil modulation or pupillary response to various lighting conditions.
The GEMINI 1 clinical trial enrolled 323 subjects who were randomised in a 1:1 ratio to receive AGN-190584 instillation once daily or vehicle (placebo).
The primary and key secondary goals were met with a statistically significantly higher number of subjects in the AGN-190584 arm gaining the ability to read three additional lines or more on a reading chart.
The ability was demonstrated in mesopic (in low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) at day 30, hours three and six as against the vehicle.
Data also showed a quick onset of 15 minutes and a duration of up to six hours in mesopic DCNVA without losing distance vision at day 30 with AGN-190584.
Furthermore, 75% of subjects in the treatment arm had a ≥two-line improvement in mesopic DCNVA while ≥20/40 vision in photopic (daylight) DCNVA was reported in 93% of subjects.
Subjects in the AGN-190584 arm had reduced use of presbyopia coping mechanisms in the last seven days of the trial.
No serious treatment-emergent adverse events (AEs) related to AGN-190584 were observed in the trial.
Headache was the most common treatment-emergent non-serious AE linked to AGN-190584 and the severity of many side effects was mild and transient.
AbbVie eye care global therapeutic area head Michael Robinson said: “If approved by the FDA, AGN-190584 is expected to be the first eye drop specifically designed for presbyopia.
“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 III GEMINI 1 clinical study.”
In October last year, Allergan announced that the Phase III GEMINI 1 and 2 trials of AGN-190584 for treating presbyopia symptoms met their primary efficacy endpoint.
Data from the GEMINI 1 and GEMINI 2 studies support the new drug application (NDA) for AGN-190584 submitted to the US Food and Drug Administration (FDA).
The FDA is currently reviewing the application and will act on it by the end of this year.