Curative Biotechnology, Inc. announced today the company has advanced into its Good Laboratory Practice (GLP) toxicology study.
The current study is designed to gauge tolerability, pharmacokinetics and any local or systemic toxicity of reformulated metformin when administered by topical ocular delivery. The study will also assess its ocular tissue distribution.
The Good Laboratory Practice (GLP) toxicology study is a requirement for an FDA Investigational New Drug (IND) filing.
Ocular tolerance includes observations at dosing, general clinical observations twice daily (evaluation of behavior/clinical signs with particular attention paid to the eyes), ophthalmic examinations by a Board-certified veterinary ophthalmologist according to the modified Hackett-McDonald scoring scale, and ocular histopathology.
Under a Cooperative Research and Development Agreement (CRADA), the National Eye Institute (NEI) and Curative Biotechnology, Inc. will collaborate to evaluate Curative’s proprietary ocular metformin formulation in clinical studies for the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.