FirstString Research, Inc — Department of Defense SBIR Phase II: A15-061

Description

Ocular traumas resultingfrom explosive or incendiary devices arecommon battlefield injuries. Current therapeutics do not address the biological and molecular processes in corneal wound healing, and therapeuticfailureis associated with corneal ulcers,scarring, and vision loss. Ocular therapeutics that haveregenerative healing properties and restorecorneal biomechanical integrity and can bereadily applied in the field willenhancetherapeutic outcome.FirstString Research has developed an eyedrop formulation containingtheshort regulatory peptide (ACT1) that possesses anti-inflammatory properties and enhancescorneal regeneration via thestabilization ofgap and tight junctions by modulatingjunctional protein interactions. During PhaseI an ACT1 ophthalmicformulation with optimal safety,stability, permeation, and retention characteristics was developed. PhaseII will1.)validatethetherapeutic potential of ACT1eyedrops with respect to corneal regeneration,scarring, and biomechanics usinglarge animal corneal injury models; and 2.)completeIND-enablingtoxicology studies in order to advanceinto clinical trials. The broader impact/commercialization potential involves the development of a CONOPS-friendly topical therapeuticthat reduces inflammation, and promotescorneal regeneration and therestoration ofvisual acuity following ocular trauma. Furthermore,results obtained willexpand the understanding of themechanisms ofcorneal damage and accelerate progress in theclinical care of ocular injuries.