Almost 90% ocular delivery success with high-precision smart micro-dosing sets new benchmark for topical instillation to the eye
NEW YORK, Nov. 28, 2018 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) today 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. 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 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.
Eyenovia, Inc. (NASDAQ: EYEN) is a specialty biopharmaceutical company building a portfolio of next generation topical eye treatments based on its proprietary delivery and formulation platform for micro-dosing. Eyenovia’s pipeline is currently focused on the late-stage development of micro-dosed medications for myopia progression, glaucoma and other eye diseases.
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The Ruth Group
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The Ruth Group