Eyenovia announced that the full results of its phase 2 PG21 study have been published in the article “Latanoprost with high precision, piezo-print microdose delivery for IOP lowering: clinical results of the PG21 study of 0.4 µg daily microdose” in the November issue of the peer-review journal Clinical Ophthalmology. The topline results of the study were first reported by the company earlier this year.
This is the first study to demonstrate the effect of Eyenovia micro-dose on IOP lowering. In the study, subjects successfully self-administered high-precision micro-dose latanoprost 88% of the time after limited training. This is a significant improvement over the standard of care eyedropper which is successfully delivered less than 50% of the time, as demonstrated by multiple peer-review studies. Additionally, a single micro-dose, which uses 75% less drug and preservative than a standard eyedrop, achieved 29% IOP lowering from baseline – consistent with the 26% effect seen in other studies of conventional eyedrop Latanoprost.
“In addition to our two previous phase 2 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 3 program, this one in glaucoma, as well as our MicroPine phase 3 trial for major back-of-the-eye indication of myopic progression, in the first half of 2019” Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release.