MicroLine achieves primary endpoint in phase 3 presbyopia study
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MicroLine achieved the primary endpoint in the phase 3 VISION-1 clinical study, demonstrating temporary improvement of near vision in adults with presbyopia, according to a press release from Eyenovia.
“A statistically significant proportion of subjects treated with a therapeutic dose of MicroLine” achieved three or more lines of improvement in distance corrected near visual acuity in low light conditions at 2 hours compared with placebo, the release said.
The pilocarpine formulation was well tolerated. There were no serious adverse events, and any other adverse events were mild.
“We are extremely pleased at the success of our VISION-1 study, marking another major milestone for our micro-array print platform technology,” Sean Ianchulev, MD, MPH, CEO and chief medical officer of Eyenovia, said in the release.
Eyenovia is planning a second phase 3 registration study, VISION-2.