Eyenovia Announces FDA Acceptance of the MydCombi NDA
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Eyenovia Announces FDA Acceptance of the MydCombi NDA
PDUFA Date Expected 4Q 2021
“We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam,” said Dr.
Approximately 90% of eye care providers reported that they encounter situations where patients avoid pharmaceutical pupil dilation often due to discomfort with the procedure, according to market research conducted by
MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient’s clinical experience. MydCombi is delivered by Eyenovia’s proprietary Optejet dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The Optejet is also designed with no protruding parts, which may help prevent accidental touching of the ocular surface.
The NDA submission was based on the MIST-1 and MIST-2 studies. In these two Phase 3 studies, a fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies’ primary endpoints and was shown to be safe and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.
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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 regulatory review timing, and 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
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Eyenovia Contact:
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
dsoltesz@pazangahealth.com
(818) 618-5634
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