By Brian Marckx, CFA
READ THE FULL EYEG RESEARCH REPORT
EYEG Submits IDE to FDA Seeking Approval to Commence Pivotal PRK Study
This morning EyeGate (EYEG) announced that they submitted an Investigational Device Exemption (IDE) application to the FDA seeking approval to commence a pivotal study for OBG in PRK. FDA turnaround is anticipated in approximately 30 days. EYEG notes that while they wait for the U.S. regulatory agency’s answer, they will continue with the initiation of the planned study which, if successful, is expected to be used as primary support for a De Novo filing.
The timing of this IDE filing is commensurate with management’s prior guidance (of filing in Q2’19). The company had previously indicated that, based on this anticipated De Novo pathway, that they hope to commence a pivotal study for PRK in Q2, complete it in Q3 and to have regulatory clearance for a PRK indication in 2020.
Next steps and could PE follow in short-order?...
We look forward to hearing additional details about the planned design of the pivotal PRK study as well as the next steps for development of OBG in PE. As it relates to the planned pivotal study for PRK, we will be particularly interested to know if the study design is single arm (such as was utilized by Allergan (AGN) with Oculeve / TrueTear) or if includes comparator (which would imply FDA requires non-inferiority or superiority). Based on EYEG’s timelines (i.e. to complete the study in Q3), that may suggest this is a single-arm study (which would further bolster our confidence of ultimate success).
As it relates to PE, we wonder if this could represent a relatively simple label expansion if and when OBG successfully navigates the De Novo pathway for PRK. More specifically, could a PE indication be added with successful completion of a relatively small, single-arm study demonstrating improvement in dry eye symptoms based on SPEED or OSDI (similar to how TrueTear secured its severe dry eye indication)? If so, and EYEG is able to meet their anticipated 2020 timeline for FDA clearance for PRK, it is conceivable that a PE indication could follow in short-order.
We also think that, assuming continued success in the PRK/PE programs, that CMHA-S could reasonably be expanded to include other indications given its safety profile and potential broad applications related to corneal wound healing. Importantly, adding indications could be a fairly streamlined process, and not necessarily require pivotal superiority (to SOC) studies. And as a reminder, in addition to Ocular Bandage Gel, Jade had already initiated development programs for CMHA-S in other applications including as an ocular surface shield and for treatment of bacterial keratitis – both of which have been funded by federal grants. OBG could have much broader utility, including outside of healing. This is something that we alluded to in 2018 following PoC data for OBG as a delivery vehicle.
See link above to our updated report for a refresher on both the OBG PRK and PR programs.
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