Eyenovia Announces Publication of its PG21 Phase II Trial Results
Eyenovia (NASDAQ:EYEN) announced that the full results of its Phase II 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. As quoted in the press release: This is …
Eyenovia (NASDAQ:EYEN) announced that the full results of its Phase II 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.
As quoted in the press release:
This is the first study to demonstrate the effect of Eyenovia micro-dose on intraocular pressure (IOP) lowering, which is the main treatment paradigm for conditions such as glaucoma. 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 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” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer.