Eyenovia Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Eyenovia, Inc.
Eyenovia, Inc.

In This Article:

Following FDA consultation, announced plans for validation of the Gen-2 Optejet? device and 2025 regulatory submission with Mydcombi? as lead product

Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4

Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years

Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the $5 billion global dry eye disease market

Company to host conference call and webcast today, August 12th, at 4:30 pm ET

NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the second quarter ended June 30, 2024.

Second Quarter 2024 and Recent Business Developments

  • Following an FDA meeting in July, announced plans for validation of the advanced Gen-2 Optejet device with production anticipated to begin in Q4 and submission in 2025 for Mydcombi as the lead product. The Gen-2 device was developed to be easier to use and manufacture, bringing the cost of goods for the monthly cartridge towards the company’s goal of $20.

  • Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia. External sources have valued the pediatric progressive myopia market at over $3.0 billion annually in the U.S. and China.

  • Announced collaboration agreements with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd. and SGN Nanopharma to develop novel therapeutics for use with Eyenovia’s Optejet? dispenser as potential treatments for dry eye disease, estimated to be a $5 billion global addressable market.

  • Reported training and shipping Mydcombi to 63 new offices from April 2024 through June 30, prior to the hiring and onboarding of its sales force; on-track to reach 263 new offices by the end of the third quarter.

  • Completed an equity placement with two of the Company’s largest shareholders.

Michael Rowe, Chief Executive Officer, commented, “During the second quarter, we made significant progress both advancing our commercial initiatives and furthering co-development agreements that can potentially address new, multi-billion-dollar underserved markets. Our plans to finalize the Gen-2 device are now set following a meeting with the FDA and we look forward to submitting this advanced technology with Mydcombi as the lead product in 2025. Meanwhile, our Mydcombi launch continues to track to plan, with this innovative mydriasis product now available in 63 new ophthalmic offices since launch, with many more coming onboard during the third quarter as momentum accelerates.”