This topic seeks the development of a topical therapeutic with regenerative properties that can be administered for treatment of mild to moderate ocular wounds of the corneal epithelium (e.g., abrasions, burns, penetrating injuries), and which can easily be applied by individuals with limited medical training. The topical therapeutic will deliver small molecules, antibodies, proteins, and/or other agents that reduce inflammation and infection, and promote re- epithelialization of damaged corneal tissue. The active components should adhere to or permeate through the ocular surface for sustained activity. Ideally the topical therapeutic will be stable under a wide range of field conditions, and have an extended shelf life. ARMY - 97
PHASE I: Phase I work will conceptualize the strategy, design the topical therapeutic(s), and test the feasibility in at least one in vitro model (e.g., corneal abrasions, burns, penetrating injuries) of corneal trauma. Appropriate markers and in vitro assays should be justified. Data obtained in Phase I will provide proof-of-concept that the active ingredient(s) will reduce inflammation and stimulate regeneration of the corneal epithelium. Appropriate controls will be used. Clinical experts with insight into ocular trauma and relevant patient populations should be consulted during design and optimization of the topical therapeutic. PHASE II: Based on Phase I results, Phase II work will test, optimize, and validate the anti-inflammatory and regenerative potential of the topical therapeutic in at least one animal model of corneal trauma (e.g., abrasions, burns, penetrating injuries). The FDA approval pathway should be outlined and considered at each developmental stage. Parameters including optimal concentrations, biological activity, toxicity, adherence to and/or permeability through the ocular surface, stability across a wide range of field conditions, and extended shelf life will be defined. Validation of efficacy will be determined through histological examination, slit lamp photography, and/or other appropriate measures. Clinical experts with insight into ocular trauma and relevant patient populations should be consulted during optimization and animal validation. Potential commercial and clinical partners for Phase III and beyond should be identified, and a detailed explanation should be provided for how the small business will obtain a monetary return on investment within two years of completion of Phase II (e.g., sales, licensing agreements, venture capital, non-SBIR grants.) PHASE III: If successful, Phase II work will result in a novel topical therapeutic with anti-inflammatory and regenerative properties for corneal trauma (e.g., abrasions, burns, penetrating injuries). During Phase III, additional experiments will be performed as necessary to prepare for FDA review of an IND application. A plan for protection of intellectual property should be created and executed. A detailed market analysis will be conducted, an initial application for the therapeutic will be selected, and a Phase I clinical trial will be initiated.