NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, has announced its financial and operating results for the fourth quarter and full year ended December 31, 2023. For the fourth quarter of 2023, net loss was approximately $8.0 million compared with a net loss of $6.1 million for the fourth quarter of 2022. For the full-year 2023, net loss was approximately $27.3 million compared with a net loss of $28.0 million for the full year 2022.

Michael Rowe, chief executive officer, commented, “During the fourth quarter and subsequent period, we continued to execute on our corporate strategy that we initiated just a few quarters ago. FDA approval of clobetasol propionate ophthalmic suspension 0.05% gives us access to a large-market indication that is complementary to Mydcombi and allows us to add additional value to eye doctors using our existing field sales force.

"Additionally, our recent decision to reacquire the development and commercialization rights to MicroPine expands our pipeline with a potential blockbuster drug, if approved. With the CHAPERONE study in our hands, we plan to engage with FDA later this year to explore ways to expedite its development.

“At the same time, we made significant progress building out our manufacturing capabilities, with FDA approval of both our Redwood City facility as well as our contract manufacturer, Coastline International. These capabilities, together with our facility in Reno, provide us the capacity to manufacture commercial supply of Mydcombi while at the same time supporting both current and future development partnerships as well as our transition from the Gen-1 to Gen-2 Optejet dispenser, beginning with Mydcombi later this year.”

Rowe added, “We also continue to work on ways to increase uptake of Mydcombi, including acceptance of our product by Vision Source, a leading group buying organization supporting optometrists throughout the United States, as well as with formulary wins at ophthalmic surgical institutions. And looking longer term, we see many opportunities to leverage the Optejet through additional collaboration and co-development agreements in high-value indications, including dry eye, which we estimate to be a $3 billion annual market opportunity in the U.S. alone.”

Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2023, compared with $2.2 million for the fourth quarter of 2022, an increase of approximately 84.6 percent. For the full-year 2023, research and development expenses were $13.0 million, a decrease of 3.0 percent as compared with $13.4 million for the full-year 2022.

Total operating expenses for the fourth quarter of 2023 were approximately $7.5 million, compared with approximately $5.4 million for the fourth quarter of 2022. This represents an increase of approximately 39.0 percent. Total operating expenses for the full-year 2023 were $25.4 million, representing a decrease of 5.6 percent versus $26.9 million for the full-year 2022.

As of December 31, 2023, the company’s unrestricted cash and cash equivalents were approximately $14.8 million, as compared with $22.9 million in unrestricted and restricted cash as of December 31, 2022.

“Overall, I am extremely pleased with our progress and our current momentum as we successfully transition to a commercial-stage, revenue generating leader in topical ophthalmic medications,” concluded Rowe.