Commercialization of a Biologic Eyedrop for Persistent Corneal Epithelial Defects

PROJECT SUMMARY This proposal aims to provide a first-in-class therapeutic to improve the quality of life for patients suffering from persistent corneal epithelial defects (PCED). PCED, whether caused by disease or trauma, can increase the risk of blindness by causing the corneal epithelium to heal slowly. If the cornea does not heal within 14 days, the condition is known as a PCED, a condition with an increased risk of recurrence and scarring that leads to vision impairment. CorneaClear eyedrops accelerate corneal healing and reduce the risk of scarring that leads to vision impairment. Our technology is unique; no products currently on the market address corneal wound healing time or the risk of scarring, regardless of the underlying cause. There is no FDA-approved therapy for the broad treatment of PCED. While Oxervate is approved for neurotrophic keratitis (NK), it only addresses one-third of PCED cases, is expensive, and is complicated to use. The long-term goal of this project is to develop an eyedrop formulation that can be prescribed to PCED patients that will speed up the healing time for corneal wounds and minimize the likelihood of scarring that can develop from extended wound-healing times. The eyedrops will be used at the onset of an abrasion for those diagnosed with PCED. Our Aim 1 states that we will demonstrate that the CorneaClear eyedrops accelerate corneal wound healing in a New Zealand White (NZW) Rabbit model. We hypothesize that, after wounding the eyes, corneal re-epithelialization will be ≥50% faster in CorneaClear- treated rabbits than in control using treatment concentrations as shown with fluorescein staining images and restoration of the epithelial layer to a thickness at least twice that of the control. Our Aim 2 states that we will confirm the systemic safety of the prolactin-induced protein eyedrops. We hypothesize no significant increase in PIP protein levels in the blood compared to the control (PIP ELISA assay) and no sign of systemic toxicity to the organs. In Phase II, we will conduct pre-clinical studies to support an Investigational New Drug Application to the Food and Drug Administration (FDA). These upcoming studies will include efficacy studies with male and female NZW rabbits and incorporate a repeated corneal wounding and healing process to simulate PCED. We also plan more rigorous safety studies under GLP/GMP conditions for Phase II. Although PCED affects almost 200,000 Americans yearly, the estimated U.S. market size for PCED therapies is estimated to be almost a billion dollars, with a predicted CAGR of 4.75% by 2030. Our regulatory strategy includes applying for an orphan drug and Fast Track designation with the FDA for PCED. We will partner with a reputable Contract Development and Manufacturing Organization and clinical research partners to advance the technology. Our target customers include corneal surgeons/ophthalmologists, patients/advocacy groups, investors, and future partners.