Eyenovia Concludes Type A Meeting With FDA Related to MydCombi NDA Resubmission

Eyenovia, Inc. recently announced that the company successfully completed a Type A meeting with the US FDA related to the refiling of the NDA for MydCombi.

On October 22, 2021, Eyenovia received a complete response letter (CRL) from the FDA stating that MydCombi, the company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation, had been reclassified as a drug-device combination product. Following the recent Type A meeting, Eyenovia and the agency reached alignment on the path forward toward an NDA resubmission. Specifically, FDA has requested that the company conduct additional device testing related to the Optejet dispenser. Importantly, no additional clinical studies of MydCombi were requested.

“We had a very constructive meeting with the FDA and confirmed the additional non-clinical items to be addressed. We are in the process of conducting these requested validation studies and plan to resubmit our NDA in Q3 2022,” stated Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “Of note, now that our product candidates are classified as combination drug/device products, we will be taking advantage of this requested validation work to streamline development activities for our future programs. One such potential benefit is the potential to reference this device validation work in future regulatory applications, reducing the time and expense of repeating these tests for each program. All in all, while we certainly would have preferred not to have this delay, we understand the legal necessity of the reclassification. Ultimately, we believe that our work today will lay the regulatory groundwork for future products. In parallel with these activities, our second Phase 3 VISION-2 clinical trial of MicroLine, our proprietary pilocarpine formulation for the temporary improvement in near vision in people with presbyopia, continues to enroll and we anticipate reporting results in the second quarter of this year. We believe the presbyopia market is a nearly $8 billion addressable market in the US alone.”

The company will elaborate further on these and other recent corporate developments during its fourth quarter update conference call in mid-March.

Eyenovia’s Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver approximately 8 μL of drug, consistent with the capacity of the tear film of the eye. We estimate the volume of ophthalmic solution administered with the Optejet is less than 20% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia’s patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% historically seen with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.

Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information, visit Eyenovia.com.