Company announce results from Phase 3 GEMINI 1 study of pilocarpine 1.25% (AGN-190584) eye drops for the treatment of presbyopia
Study (n=323) met primary and key secondary endpoints with a statistically significantly higher number of participants able to read 3 additional lines on a reading chart in pre-specified conditions at Day 30, Hour 3 (22.5%, p<0.0001) and Hour 6 (9.7%, p =0.0114) vs the vehicle
Source:
Biospace Inc.
SPS commentary:
GEMINI 1 data, in combination with data from the GEMINI 2 study, formed the basis of the AGN-190584 New Drug Application (NDA) currently under review with the FDA