ProtoKinetix Engages Multi-National Partner for Formulation of Topical Drug to Treat DED & Ocular Inflammation

ProtoKinetix announced that it has engaged a global pharmaceutical company to develop the formulation as a topical ocular drug for the treatment of dry eye disease (DED) and ocular inflammation using AAGP.

For the development of this drug for DED to date the company has completed:

1. Ocular irritation studies
2. Proof of concept pre-clinical DED trials for efficacy
3. Confirmatory pre-clinical DED trials for efficacy
4. Pilot drug stability (ie. shelf-life) testing
5. Pilot tolerability and toxicology studies

All these studies were conducted by market-leading contract research organizations (CRO).

In order to progress to clinical trials, the company intends to complete the following activities:

1. Complete topical application formulation(s)
2. Confirmatory DED efficacy tests
3. Drug product Good Lab Practice (GLP) IND-enabling safety toxicology
4. Communicate with Federal Drug Administration (FDA) on clinical trial design criteria