You are here
Eyenovia Announces Publication of its PG21 Phase II Trial Results Demonstrating Robust IOP Lowering Effect and Patient Usability
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.
Forward Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the SEC. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks involved in clinical trials, including, but not limited to, the initiation, timing, progress and results of such trials; the timing and our ability to submit applications for, obtain and maintain regulatory approvals for, our product candidates; our ability to develop and implement commercialization, marketing and manufacturing capabilities and strategies; the potential advantages of our product candidates; our ability to attract and retain key personnel; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; intellectual property risks; our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; our expectations regarding our ability to fund our operating expenses and capital expenditure requirements; the impact of government laws and regulations; our competitive position; and general economic conditions. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statements.
Chief Financial Officer
The Ruth Group