Eyenovia Announces FDA Approval of Redwood City as Commercial Manufacturing Facility

Redwood City, California to complement Eyenovia’s facility in Reno, Nevada as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi

NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced that the company’s facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily be used for final assembly, packaging and labeling activities in support of Mydcombi, the first and only fixed combination of tropicamide and phenylephrine for in-office and pre-surgical pupil dilation utilizing Optejet technology.

Redwood City complements Eyenovia’s manufacturing capabilities in Reno, as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi in the Company’s proprietary Optejet dispensing platform.

“The FDA inspection of our Redwood City facility was completed efficiently and with no significant concerns raised on the part of the inspector, clearing the way for us to perform final assembly, packaging and labeling in support of a broader U.S. launch of Mydcombi,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “With Redwood City and Reno now online and operational, we have the capacity to manufacture both commercial product as well as clinical supply in support of our ongoing CHAPERONE clinical trial for pediatric progressive myopia as well as initial testing of other product candidates that leverage our Optejet technology.”   

“I am very pleased with the results of the audit and commend our manufacturing, engineering, quality and regulatory staff for their diligence and work to make this a reality,” added Bren Kern, Chief Operating Officer. “The team had been working tirelessly in preparation for this key milestone and their efforts bore out in the result.”

PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis.