November 3, 2023
NEW YORK — Eyenovia, Inc., announced that the FDA has approved Eyenovia’s Supplemental New Drug Application (sNDA), adding Coastline International as a contract manufacturer. Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).
“One of the many benefits of Mydcombi is that, unlike eye droppers, there is no protruding tip that can come in contact with the patient’s eye. In many applications today, eye care institutions and surgeons are discarding bottles after each use to prevent this risk of cross-contamination, creating waste and unnecessary expense,” stated Michael Rowe, chief executive officer of Eyenovia. “We believe Mydcombi, because of its design, addresses this challenge and can provide significant cost savings to doctors and surgical centers. With FDA approval of Coastline, our manufacturing capabilities are in place, and we anticipate initiating Mydcombi commercial production imminently with the goal of having product available to ship in January of 2024.”
In addition to commercializing Mydcombi, in August 2023, Eyenovia acquired the U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa Pharmaceuticals. APP13007, which is currently under review by the FDA, is a potent steroid being developed to reduce pain and inflammation with twice-a-day dosing following ocular surgery. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia and myopia progression (partnered with Bausch+Lomb in the U.S. and Canada and Arctic Vision in China and South Korea).
