Eyenovia Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia
Eyenovia announced that the first patient has been enrolled in the company’s second Phase 3 clinical trial of MicroLine, its proprietary pilocarpine formulation for temporary improvement in presbyopia, known as VISION-2.
“Following the completion of VISION-1 study, we are pleased to initiate this second phase 3 trial that, if successful, will contribute to the clinical evidence supporting a new drug/device combination application to the US FDA,” Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia, said in a company news release. “By leveraging the numerous benefits of our microdose array print (MAP) technology, we believe MicroLine has the potential to be among the first drug treatments to improve blurred near vision that can adversely impact quality of life in patients with presbyopia.”
“Additionally, with 18 million people between the ages of 40 and 55 in the US afflicted with presbyopia, this is a significant market opportunity for our company – in excess of several billion dollars according to very recent third-party market research. We look forward to continuing to advance this promising and differentiated therapeutic through late-stage development for the potential benefit of patients, eye care practitioners and shareholders alike.”
The VISION-2 study is a double-masked, placebo-controlled, cross-over superiority trial in which approximately 140 subjects with presbyopia will be treated. During the study, subjects will be randomly assigned to a treatment sequence for dosing with pilocarpine 2% as well as placebo, both administered via the Optejet dispenser. The primary endpoint is improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after treatment. Topline data is expected in mid-2022.
VISION-1 recap
In May 2021, Eyenovia announced positive results from the first phase 3 MicroLine study, VISION-1. In that trial, the primary endpoint was achieved with MicroLine 2% statistically superior to placebo, determined by improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after treatment. Further, MicroLine was very well tolerated; adverse events reported were all mild and transient in nature including fewer than 3% of patients reporting brow/headache. In a post-study survey, 70% of study participants reported strong interest in using MicroLine for near vision improvement should it be approved. These patients said they would expect to use the product three to four times per week on average.
About the VISION Trials
The VISION trials are phase 3, double-masked, placebo-controlled, cross-over superiority trials that enroll participants with presbyopia. The primary endpoint is improvement in high-contrast binocular distance corrected near visual acuity in low light conditions. MicroLine is intended for the “on demand” improvement of near vision in people with presbyopia.