FDA Approves Eyenovia’s Redwood City as Commercial Manufacturing Facility

Eyenovia announced the successful completion of the FDA inspection for its facility in Redwood City, California, marking a significant milestone in the company's manufacturing capabilities.

This achievement signals the green light for the facility to engage in final assembly, packaging, and labeling activities crucial for the production of Mydcombi, a fixed combination of tropicamide and phenylephrine designed for in-office and pre-surgical pupil dilation.

The Redwood City site will play a pivotal role in complementing Eyenovia's existing manufacturing infrastructure in Reno, Nevada, along with its contract manufacturer, Coastline International. Together, these facilities will facilitate the commercial supply of Mydcombi utilizing Eyenovia's proprietary Optejet dispensing platform.

Michael Rowe, Eyenovia’s Chief Executive Officer, expressed his satisfaction with the outcome of the FDA inspection, emphasizing the efficiency and seamless process. He stated, "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."

Rowe further highlighted the strategic significance of having both Redwood City and Reno facilities operational, underscoring their capacity to meet the demand for commercial products and clinical supply. He mentioned, "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."

Bren Kern, the company’s COO, said: “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. The team had been working tirelessly in preparation for this key milestone and their efforts bore out in the result.”