Phase III GEMINI 1 and 2 clinical trials of AGN 190584 meet primary endpoints in presbyopia.- Allergan/AbbVie

Allergan/AbbVie announced the Phase III 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 three lines (the ability to read three additional lines on a reading chart) 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. GEMINI 1 and 2 enrolled a total of 750 patients randomized in a one-to-one ratio of vehicle (placebo) to AGN 190584 (pilocarpine 1.25%). AGN 190584 was administered bilaterally, once-daily, for 30 days in both GEMINI 1 and 2 participants with presbyopia. In the GEMINI studies, AGN 190584 demonstrated significant near vision gains in mesopic (in low light) conditions without a loss of distance vision. There were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. The most common treatment emergent non-serious adverse events occurring at a frequency of at least 3% in AGN 190584 treated participants were headache, conjunctival hyperaemia, vision blurred, and eye pain. In both studies, the primary endpoint was met. The majority of secondary endpoints were also met in both studies, including a significant improvement in patient-reported outcomes (PROs) such as an increase in vision-related reading ability, and reductions in the impact of presbyopia on daily life and use of coping behaviors to manage presbyopia. 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.