As our population ages there comes an increased demand for therapies to treat age related ocular diseases such as Age-related Macular Degeneration (AMD), glaucoma, diabetic retinopathy and dry-eye. In fact, the global market for ocular drugs is expected to reach $21.6 billion by 2018 according to a Transparency Market Research article.
Successful bioanalysis in toxicology/PK studies for the three routes of ocular drug administration (topical, ocular injection, and systemic) have different complexities and challenges but, at a minimum, require:
- Wide range bioanalytical assay to quantitate drug level concentrations in various eye tissues
- Highly skilled surgeons at the animal/Tox facility to ensure proper dissection of the various eye tissues to be analyzed for drug levels
- Very sensitive plasma assay to confirm or prove that drug is not in systemic circulation at levels above the NOEL (no observable event level)
The tissue analysis required for ocular therapeutics presents its own unique challenges:
- Homogenizing the various ocular tissues to allow consistent extraction of the drug – Will the homogenization procedure that works for retina be sufficient for cornea or sclera?
- Procuring ‘rare’ matrices in appreciable volumes to allow for specificity, recovery, accuracy, and precision experiments to demonstrate assay robustness – Is it worth considering surrogate matrices?
- Developing a bioanalytical PK assay that may cover multiple tissues to keep overall assay costs down – Why validate 5 or more methods when 2 or 3 will suffice?
- Using a fit-for-purpose approach to assay development to balance regulatory agency requirements with budgets – Are all of your ocular tissues primary matrices?
Often, for topical or ocular injection routes of administration, the ability to demonstrate systemic drug levels below NOEL may help in reducing the overall toxicology program for regulatory submission. This process can save millions of dollars in development costs and cut years off drug development timelines but requires a skilled bioanalytical lab that can develop and validate highly sensitive blood, plasma or serum PK assays.
Finally, selecting a toxicology/animal facility experienced in ocular drug administration that also has a team of skilled surgeons to properly dissect the various ocular tissues is paramount to your program’s success. By choosing a bioanalytical lab that has partnered with several in-life facilities you benefit from comprehensive services without compromising on either bioanalytical expertise or surgical precision.
Contact us to learn more and see how AITB can help you!