Eyenovia Announces Publication of MIST Pivotal Studies Demonstrating the Efficacy and Safety of its MAP™ Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis
News Release
View printer-friendly version << Back
Eyenovia Announces Publication of MIST Pivotal Studies Demonstrating the Efficacy and Safety of its MAP™ Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis
The publication features pooled results from two prospective, double-masked, controlled, cross-over superiority Phase 3 studies that concluded a micro-dosed fixed-combination of tropicamide 1% and phenylephrine 2.5% for pupil dilation (mydriasis) is safe and effective and produced clinically relevant and statistically superior pupil dilation compared with either agent alone and placebo.
Approximately 93% of eyes treated with tropicamide-phenylephrine achieved 6 mm or greater dilation at 35 minutes post-dose as compared to 78% with tropicamide and 2% with phenylephrine. Additionally, the proportion of fully non-responsive pupils at 35 minutes post-dose was 98% with tropicamide-phenylephrine compared with 76% and 5%, respectively, with tropicamide and phenylephrine alone. Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain. The pooled analysis included 131 subjects and all treatment arms used Eyenovia’s proprietary Optejet®, a first-of-its-kind dispenser designed for high precision targeted administration, delivering approximately 80% less medication and preservatives to patients than eyedroppers and potentially improving local tolerability.
“Pupil dilation has a deserved reputation for being a cumbersome, time consuming and often uncomfortable part of eye exams, which is why many patients dislike and sometimes forego it,” said
This publication follows the
“This publication further validates that microdosed tropicamide-phenylephrine with our proprietary and novel Optejet dispenser has many advantages that could make pupil dilation easier, more comfortable and safer. The Optejet may reduce the risk of cross-contamination because unlike an eyedropper bottle, the Optejet has no protruding parts. The MAP drug delivery may also enable anesthetic-free dilation and streamlines care, making the process more efficient,” said
MydCombi was developed to address several challenges eye care practitioners and their patients face related to pupil dilation, a procedure conducted during most of the estimated 80 million office-based comprehensive and diabetic eye exams performed in the
“Dilating the pupil is a challenging, albeit critical part of any comprehensive eye exam, providing eye care professionals with the necessary clarity and visibility to fully examine the eye,” said
“Clinicians and eye care professionals have long been ready for options beyond eye drops, which by design, often expose patients to higher-than-needed doses of medication and prolong eye exams,” said William J Flynn MD, Clinical Professor of
About
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, including estimated market opportunities for our product candidates and platform technology. 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210317005112/en/
Eyenovia Contact:
John Gandolfo Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
schoinksi@pazangahealth.com
(860) 301-5058
Source: