3 March 2021 - - The US Food and Drug Administration has accepted US-based clinical stage ophthalmic biopharmaceutical company Eyenovia, Inc's (NASDAQ: EYEN) New Drug Application for MydCombi, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80m comprehensive eye exams currently conducted each year in the United States, the company said.

If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet.

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 J. Reckner Associates.

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.

Eyenovia is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.