Eyenovia pushes ahead with eye drug trials as it unveils 4Q results

Eyenovia (NASDAQ:EYEN) on Wednesday unveiled a number of pivotal advances in trials for its eye disorders drugs as the ophthalmic biopharmaceutical company announced fourth-quarter results.

On its list of quarterly achievements is the reporting of rosy results for its MicroStat Phase 3 MIST-1 and MIST 2 studies, which take aim at mydriasis or pupil dilation.

On the back of the results, the New York company is looking to file a new drug application for MicroStat in 2020.

READ: Eyenovia shares surge on optimistic late-stage MicroStat trial

“We were very excited to announce positive results from our first Phase III program, MicroStat, for pharmacologic mydriasis,” said Dr. Sean Ianchulev, Eyenovia’s CEO and chief medical officer in a statement. “The results from the MIST 1 and MIST 2 trials confirmed that our fixed-combination phenylephrine-tropicamide formulation met the primary efficacy outcome of mean pupil dilation at 35 minutes post administration.”

Eyenovia has developed a pipeline of microdose therapies using a patented delivery system which focus on treatment for pupil dilation, the progression of nearsightedness, glaucoma and other eye diseases.

In other good news from the quarter, the FDA accepted an investigational new drug application to kick off its Phase III MicroPine treatment study which is looking to reduce the progression of myopia or nearsightedness in children.

Glaucoma drug testing in view

On top of this, the company is also looking to kick off another Phase 3 program for its glaucoma treatment MicroProst this year, which will include patients with chronic angle closure glaucoma, open angle glaucoma and ocular hypertension in a single study. MicroProst is Eyenovia’s flagship drug candidate to reduce intraocular pressure in patients with various forms of glaucoma.

“We believe that our novel platform technology has the potential to transform the treatment of front and back-of-the-eye diseases,” noted Dr. Ianchulev.

In the fourth-quarter, the pre-revenue company’s net loss came to $6.2 million, or $0.60 per share, compared to a loss of $2.2 million, or $0.84 per share, in the year-ago quarter. Analysts on Wall Street had expected Eyenovia to lose $0.43 per share.

The company’s research and development expenses climbed to $4.1 million in the fourth quarter, compared to $1.7 million in the corresponding period a year ago.

Eyenovia slipped 0.9% to close at $5.30 on Tuesday.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors