Allergan's presbyopia med successful in late-stage studies

• AbbVie's (NYSE:ABBV) Allergan has announced Phase 3 GEMINI 1 and 2 trials evaluating AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of symptoms associated with presbyopia (age-related farsightedness), have met primary efficacy endpoint.
• In GEMINI 1, the primary endpoint was met with a statistically significant greater proportion of subjects treated with AGN-190584 who gained three lines (the ability to read three additional lines on a reading chart) or more in low light, high contrast, distance corrected near visual acuity at Day 30, versus placebo.
• In GEMINI 2, higher number of patients in AGN-190584 arm were able to read three additional lines without loss of greater than five letters, compared to placebo.
• Majority of secondary endpoints were also met in both studies, including 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 the company intends to file marketing application with the FDA in 1H of 2021.
• On safety front, there were no treatment emergent serious adverse events observed in any AGN-190584 treated participants. Most common treatment emergent non-serious adverse events occurring in AGN-190584 group were headache, conjunctival hyperaemia, vision blurred, and eye pain.
• Presbyopia is a common and progressive eye condition that reduces the eye’s ability to focus on near objects and usually impacts people after age 40
• https://seekingalpha.com/news/3627213-allergans-presbyopia-med-successful-in-late-stage-studies