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T O P I C     R E V I E W
jackbequick  - posted
ProtoKinetix Engages Multi-National Partner for Formulation of Topical Drug to Treat Dry Eye Disease & Ocular Inflammation with AAGP®

Marietta, Ohio, April 14, 2021
ProtoKinetix, Incorporated (the "Company" or "ProtoKinetix") (OTCQB: PKTX), a clinical-stage biomedical company, today 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:
Ocular irritation studies
Proof of concept pre-clinical DED trials for efficacy
Confirmatory pre-clinical DED trials for efficacy
Pilot drug stability (ie. shelf-life) testing
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:
Complete topical application formulation(s)
Confirmatory DED efficacy tests
Drug product Good Lab Practice (GLP) IND-enabling safety toxicology
Communicate with Fedral Drug Administration (FDA) on clinical trial design criteria

Dry Eye Disease Market Overview
According to market research published by Mordor Intelligence LLP, studies of the Dry Eye Disease market indicated a value of approximately USD 4.5 billion in 2018, and the market is expected to reach up to USD 6.2 billion by 2024, with an anticipated CAGR of 5.23%, during the forecast period (2019-2024). The growth of dry eye related diseases may include several factors, such as aging, a decrease in the supportive hormones (ex. menopause), systemic inflammatory diseases, ocular surfaces diseases or surgeries affecting the cholinergic nerves, which stimulate tear secretion.

“This is a critical milestone in our application development and moves us forward to commercialization of ProtoKinetix’s Dry Eye Disease program.” – Clarence Smith, CEO President
See the promising research of AAGP® and results to date
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