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Translation From Ophthalmic Research to Ophthalmic Products
Gary D Novack1, William J Brock2, Audrey R Schupp3
1From the PharmaLogic Development, Inc. (G.D.N.), San Rafael, California, USA; Department of Ophthalmology & Vision Science (G.D.N.), University of California School of Medicine, Davis, California, USA.
American Journal of Ophthalmology
|May 11, 2025
Summary
This guide aids academic researchers in translating novel ophthalmic drug research into early-stage development and clinical trials. It outlines key requirements for successful ophthalmic product development.
Area of Science:
- Ophthalmology
- Drug Development
- Translational Science
Background:
- Ophthalmic drug development requires specialized knowledge.
- Transitioning from research to clinical trials presents unique challenges.
Purpose of the Study:
- To provide guidance for academic researchers on developing novel ophthalmic drugs.
- To facilitate the translation of research into early-stage clinical development.
Main Methods:
- Review of existing guidelines.
- Incorporation of authors' extensive product development experience.
- Presentation of requirements for chemistry, nonclinical, clinical, and regulatory aspects.
Main Results:
- Chemistry requirements for drug substance and formulated product.
- Nonclinical requirements including pharmacology, pharmacokinetics, and toxicology.
- Clinical and regulatory development pathways.
Conclusions:
- Successful novel ophthalmic product development is a structured process.
- The process is sequential and interactive.
- This guidance supports researchers in navigating the development pathway.
