FDA Approves Eyenovia’s Mydcombi, First Ophthalmic Spray for Mydriasis

Eyenovia Inc. announced that the FDA has approved Mydcombi, a groundbreaking ophthalmic spray that induces mydriasis for diagnostic procedures and short-term pupil dilation.

This marks the first approved, fixed-dose combination of tropicamide and phenylephrine in the United States and also the first to use Eyenovia's cutting-edge Optejet device to receive regulatory approval.

Mydcombi is designed to enhance the effectiveness of approximately 106 million office-based comprehensive eye exams conducted annually in the United States, as well as around 4 million pharmacologic mydriasis applications for cataract surgery. It is important to note that the product is not recommended for use in patients who have a known allergy to any of the formulation's ingredients.

“The approval of Mydcombi, our first FDA-approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” Rowe said in the statement. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024,” said Michael Rowe, CEO of Eyenovia.

Additionally, Rowe emphasized that the approval of Mydcombi by the FDA serves as a validation of the Optejet platform. This milestone marks the first product approved utilizing the Optejet device, which is essential not only for Eyenovia's internal development projects, such as MicroLine for presbyopia, but also for their collaborative ventures.

Eyenovia's Optejet technology was utilized to administer treatments in the two completed Phase 3 clinical trials of MydCombi, namely MIST-1 and MIST-2. MIST-1 (NCT03751631) involved comparing MydCombi to phenylephrine (PE) and tropicamide (TR) used alone, while MIST-2 (NCT03751098) compared MydCombi to placebo.

Eyenovia's Mydcombi is an ophthalmic spray consisting of tropicamide 1% and phenylephrine 2.5%, which is intended for inducing pharmacologic mydriasis (eye dilation) and aimed at improving the efficiency of around 100 million comprehensive eye exams conducted annually in the United States, as well as the approximately 4 million pharmacologic mydriasis applications used in cataract surgery. Mydcombi is formulated as a micro-dose that can be used without anesthesia, and Eyenovia expects it to enhance the effectiveness, tolerability, and efficiency of pharmacologic mydriasis.