NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), an ophthalmic pharmaceutical technology company, has announced the successful completion of an FDA inspection at its Redwood (NYSE:RWT) City, California facility, which is now approved for commercial manufacturing. This facility will handle final assembly, packaging, and labeling of Mydcombi, a combination treatment for pupil dilation.
The Redwood City site is part of Eyenovia's manufacturing network, including a facility in Reno, Nevada, and its contract manufacturer, Coastline International. The company's CEO, Michael Rowe, expressed satisfaction with the efficient inspection process and the absence of significant concerns from the FDA. This approval is a key step in expanding the U.S. launch of Mydcombi, which utilizes Eyenovia's proprietary Optejet technology.
Chief Operating Officer Bren Kern commended the team's efforts in preparation for the audit. With this milestone, Eyenovia aims to support the commercial production of Mydcombi and the clinical supply for ongoing trials, such as the CHAPERONE study targeting pediatric progressive myopia.
Mydcombi is the first and only fixed combination of tropicamide and phenylephrine for in-office and pre-surgical pupil dilation. Eyenovia is also working on other product candidates, including APP13007, a treatment for post-ocular surgery pain and inflammation, which is currently under FDA review with a PDUFA action date set for March 4, 2024.
Eyenovia continues to advance late-stage development of medications for presbyopia and myopia progression in partnership with Arctic Vision in China and South Korea. The company focuses on microdose array print therapeutics and aims to leverage its Optejet platform technology to enhance ophthalmic treatments.
This announcement is based on a press release statement from Eyenovia. The company's forward-looking statements involve risks and uncertainties, and there is no guarantee that future results will align with current projections. Eyenovia has not undertaken any obligation to update any forward-looking statements.
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