29 December 2020 - - US-based clinical stage ophthalmic biopharmaceutical company Eyenovia, Inc. (NASDAQ: EYEN) has submitted a New Drug Application to the U. S. Food and Drug Administration for MydCombi, a unique fixed combination mydriatic (pupil dilation) agent, the company said.

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

The NDA submission follows the initial enrollment of the VISION-1 study, Eyenovia's Phase 3 study for MicroLine in presbyopia, with top-line data expected the first half of 2021.

MydCombi was developed to address several needs of the eye care practitioner's office. Pupil dilation is conducted during most of the estimated 80 m office-based comprehensive and diabetic eye exams performed in the US annually.

The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow.

The design of eyedroppers also lends itself to the possibility of inadvertent contact with the eye itself, which may be an issue as the same eyedropper bottle is often shared among a number of patients.

In contrast, 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 product 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 phenylephrine 2.5% and tropicamide 1% ophthalmic solution 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. All adverse events were infrequent at 3.1%; fewer than 1% of patients reported blurred vision, reduced acuity, photophobia or instillation site pain.

Eyenovia, Inc. (NASDAQ: EYEN) 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.