Topical Therapeutic for Ocular Trauma

The main objective of this Phase II proposal is to optimize a silk-derived protein therapeutic fraction (SDP-TF) for use in an ophthalmic formulation to enhance corneal wound healing post traumatic injury by simultaneously inhibiting inflammation and stimulating epithelium regeneration, which are two key factors in optimizing full visual recovery. To accomplish this, this proposal sets out to complete three Objectives: (1) generate an ophthalmic formulation containing SDP-TF; (2) evaluate the toxicity profile and long-term stability of the SDP-TF product; and (3) perform animal trials assessing post-PRK treatment with SDP-TF. At the conclusion of this work the SDP-TF formulation will have been well characterized materially, toxicologically, and for in vivo efficacy within an animal wound healing model. This data will be utilized to lay the foundational work for an IND application to the FDA and future human clinical trials during the Phase III development period.