Eye-Aid System for Acute Ocular Injuries

To support the initial management of undifferentiated ocular injuries in the absence of an ophthalmologist, including full-thickness corneal and corneoscleral wounds, US military end users and customers require a solution that addresses this important clinical problem. Critical Innovations, in conjunction with Eva Chou, MD (USN), CAPT David Tanen MD, FAAEM, FACMT (USN, Ret.), and former Commander Denise Whitfield, MD, FACEP, have formed a team of experts to address this important need. During this Direct-to-Phase II project, our objective will be to continue prototype refinement/maturation progressing toward a production-equivalent product and to produce sufficient devices under current Good Manufacturing Practice (cGMP) for the pre-clinical and stability testing planned under this program. Phase II technical objectives include: device refinement and pilot run of production-equivalent devices for use in subsequent testing; performance of a GLP preclinical efficacy study as informed by FDA guidance; performance of additional studies to demonstrate product stability; and maintenance of all program-specific regulatory compliance requirements while preparing for upcoming regulatory and transition hurdles.