Eyenovia Inc (NASDAQ: EYEN) reported Q4 EPS of ($0.60), $0.17 worse than the analyst estimate of ($0.43).

• Reported positive results in the MicroStat Phase III MIST-1 and MIST-2 registration studies for mydriasis;
• U.S. Food and Drug Administration (FDA) accepted investigational new drug (IND) application to initiate MicroPine Phase III CHAPERONE registration study to reduce the progression of myopia in children;
• Expanded and streamlined the MicroProst Phase III program to include chronic angle closure glaucoma (CACG), as well as open angle glaucoma (OAG) and ocular hypertension (OHT) patients in a single registration study;
• Published positive results from the EYN PG21 trial evaluating high-precision microdose latanoprost demonstrating robust intraocular pressure lowering; and
• Completed underwritten follow-on public offering of Company common stock with gross proceeds of approximately $3.4 million, excluding underwriting discounts and commissions and offering-related expenses.

Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer commented, “Throughout 2018, we worked diligently to advance all of our clinical programs and further validate the efficacy of our high-precision microdosing platform technology. We were very excited to announce positive results from our first Phase III program, MicroStat, for pharmacologic mydriasis. 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. We believe that these results not only further validate our microdose platform technology, but also demonstrate its potential to increase physician efficiency and patient through-put volume in real world applications. We are now preparing to initiate registration and stability manufacturing lots for MicroStat and expect to file our NDA in 2020.”

“In addition to our success with MicroStat, the FDA acceptance of our MicroPine IND application represents another milestone achievement that will allow us to initiate the Phase III registration trial this year. We also expect to initiate another Phase III program with MicroProst this year with an expanded study population including patients with CACG, OAG and OHT representing what we believe is one of the broadest patient populations in glaucoma drug development to date.”

“I would like to thank our highly motivated team as well as our shareholders who helped us make 2018 a success. We look forward to continuing to execute on our clinical initiatives, including the OTC monograph registration of MicroTears this year. We believe that our novel platform technology has the potential to transform the treatment of front and back-of-the-eye diseases,” concluded Dr. Ianchulev.

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