Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology.
The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure.
In the trial, participants successfully self-administered using Eyenovia’s device 88% of the time after limited training. Latanoprost, which is often prescribed to lower intraocular pressure, is successfully delivered using a traditional eyedropper less than 50% of the time, according to Eyenovia.
The company also reported that a single micro-dose achieved 29% intraocular pressure lowering from baseline, which is consistent with the 26% effect experienced with a traditional eyedropper in other studies.
“In addition to our two previous Phase II studies in mydriasis, we believe that PG21 further demonstrates that micro-dosing is well tolerated, easily delivered and therapeutically effective without the waste, discomfort and ocular overdosing associated with legacy eyedropper delivery. Eyenovia plans to initiate our second front-of-the-eye Phase III program, this one in glaucoma, as well as our MicroPine Phase III trial for major back-of-the-eye indication of myopic progression, in the first half of 2019” CEO & CMO Dr. Sean Ianchulev said in prepared remarks.
Also this week, Eyenovia enrolled the first patient in the first of two Phase III trials of the company’s MicroStat program.
The Mist-1 and Mist-2 trials are slated to study the safety and efficacy of the company’s 2.5% phenylephrine, 1% tropicamide eye solution, delivered as a micro-dose using the Optejet device. The company is assessing its combination therapy for pharmacologic mydriasis – pupil dilation for eye exams.
