- Allergan, a unit of AbbVie Inc ABBV, has announced new data, including the full results from the Phase 3 GEMINI 1 study of AGN-190584 (pilocarpine 1.25%) ophthalmic solution for presbyopia.
- Multiple data presentations were made at the 2021 ASCRS Annual Meeting.
- Data demonstrated that AGN-190584 met both its primary and key secondary efficacy endpoints, with patients achieving near and intermediate vision gains.
- In addition, AGN-190584 showed no loss of distance vision, rapid onset of action, and sustained vision gains of up to six hours.
- Presbyopia is a progressive eye condition that makes it difficult to focus on things up close and affects most adults over 40.
- A statistically significant greater proportion of participants treated with AGN-190584 gained the ability to read three additional lines on a reading chart in low light, high contrast, at Day 30, Hour 3 (22.5%), and Hour 6 (9.7%) versus the vehicle.
- Additional endpoints evaluated showed that 75% of participants treated with AGN-190584 achieved at least 2-line improvement, and 93% of participants achieved over 20/40 vision in photopic (daylight) DCNVA.
- No treatment-emergent serious adverse events were observed in any AGN-190584 treated participants.
- The most common treatment-emergent non-serious adverse event in the AGN-190584 group was a headache.
- Most side effects were mild and transient, with only 1.2% of patients discontinuing due to adverse events.
- Price Action: ABBV shares closed at $118.19 on Friday.
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