The objective of this project is to develop an eye drop which is more effective than other existing therapies in treating Acanthamoeba keratitis. While a relatively uncommon type of corneal infection, Acanthamoeba keratitis is painfully debilitating and vision-threatening. It is extremely difficult to treat, and the consequences of failure are severe. There is currently no FDA-approved treatment for Acanthamoeba keratitis. Off- label use of various disinfecting agents and antibiotics has provided moderately successful therapy. However, the optimal drug combinations and concentrations and safety of use are not well defined. Bio-Concept Laboratories intends to develop and obtain FDA-approval for a combination of drugs which will be safe and effective. During Phase I of the SBIR funding period, experimental formulations suitable for use on the eye were developed and tested against Acanthamoeba in two distinct in vitro systems. The results showed the ability of the test solutions to kill Acanthamoeba, prevent the cytopathic effect of the parasite in vitro, and give an indication of the optimal concentrations of drug required for therapeutic use. During Phase II, this formulation will be tested in animal models for Acanthamoeba keratitis. The disease will be induced in Chinese hamsters and pigs, and the effectiveness of drug treatment will be tested against untreated control animals with the disease. Once an effective concentration is determined in the animal model, ophthalmic safety parameters will be established by conducting regulated toxicology studies. Synthesis of the active ingredient will also be required, since it will no longer be available for health care use. Manufacturing procedures and method validation will be conducted as required for sumission to the FDA under an Investigative New Drug application. PROPOSED COMMERCIAL APPLICATION: Although the incidence of Acanthamoeba infection is relatively low, there is currently no FDA-approved method for treatment. Thus the Bio-Concept product could capture a major portion of the market. Furthermore, our product has the potential for a broader application which would be effective in treating other ocular microbial infections, substantially increasing potential market value
