NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, has announced its financial and operating results for the quarter ended March 31, 2024. For the first quarter of 2024, the net loss was approximately $10.9 million, compared with a net loss of $5.7 million for the first quarter of 2023, the company said. The first quarter 2024 net loss includes $2.5 million of expense associated with the reacquisition of the license rights from Bausch for MicroPine, and the write off of related clinical trial inventory, according to the announcement.

Michael Rowe, Eyenovia’s chief executive officer, said, “During the first quarter of 2024, we took tangible steps to increase the inherent value of our company, which currently includes our novel Optejet technology, two FDA-approved products, and a third in late Phase 3 development.

“With highly differentiated and desirable products such as Mydcombi for mydriasis and clobetasol for post-surgical pain and inflammation, we look forward to meaningful sales growth over the next 18 months that we anticipate will lead us toward profitability. And our crown jewel, MicroPine for progressive myopia, if approved, would add significant value to the company by addressing a key unmet medical need of the approximately five million at-risk children in the U.S. alone.”

Other key highlights from the financial report included the following:

● Research and development expenses totaled approximately $4.4 million for the first quarter of 2024, compared with $2.5 million for the first quarter of 2023, an increase of approximately 75.7 percent.

● For the first quarter of 2024, general and administrative expenses were approximately $3.8 million, compared with $2.9 million for the first quarter of 2023, an increase of approximately 30.6 percent.

● Total operating expenses for the first quarter of 2024 were approximately $10.3 million, including the previously referenced $2.5 million of expenses associated with the Bausch transaction, compared with approximately $5.5 million for the first quarter of 2023. This represents an increase of approximately 88.1 percent. The first quarter 2024 operating expense figure includes approximately $1.5 million of non-cash expenses.

Rowe said, “We believe the progress that we continue to make toward optimizing our platform technology has laid a strong foundation toward transforming Eyenovia into a leader in the development and commercialization of topical ophthalmic products and medications. We are committed to demonstrating the value of our existing and near-term products as well as future product candidates in ophthalmic markets with high unmet needs.

“At the same time, we completed the build-out of our manufacturing capabilities, with FDA approval of our Redwood City location in addition to our Reno facility and Coastline International as our contract manufacturer. With all three facilities online, we are currently producing 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. To that end, we recently requested a meeting with the FDA to discuss our validation of the Gen-2 dispenser, which we anticipate will occur this summer,” Rowe concluded.

Other key business developments from the financial report include the following:

● Announced updated plans to accelerate development of MicroPine, its late-stage product candidate for pediatric progressive myopia. These plans include a protocol amendment to allow for a data monitoring committee to review the Phase 3 CHAPERONE study data early in the fourth quarter.

● Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery. Eyenovia is planning a launch of this product in the third quarter of 2024.

As of March 31, 2024, the company’s unrestricted cash and cash equivalents were approximately $8.0 million, not including $2.2 million in additional capital that the company raised in April 2024.