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Insight on a 2020 Virtual Meeting CE Course: “Developing Therapeutics for Ocular Indications: A 20/20 View”

By Mercedes Salvador-Silva posted 04-23-2020 13:51

  

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On Friday, April 10, 2020, as part of the 2020 SOT Virtual Meeting, I attended the live webinar for the Continuing Education (CE) course “Developing Therapeutics for Ocular Indications: A 20/20 View.” This session was endorsed by the Ocular Toxicology Specialty Section (OTSS); the Biotechnology Specialty Section; and the Comparative Toxicology, Pathology, and Veterinary Specialty Section. The course featured four speakers.

Before I proceed, it would be appropriate to state my conflict of interest as former President of the OTSS. However, the words expressed in this post reflect my opinion and not the thoughts or views of OTSS.

Seth Eaton, VMD, DACVO, of the University of Wisconsin–Madison opened the course with an overview of the ocular anatomy and physiology in mammals. Dr. Eaton discussed the laboratory species differences and the challenges associated with human diseases and the ocular models. The talk also illustrated the challenges associated to ocular administration of drugs and biologics. As final remark, Dr. Eaton emphasized that for an ocular model to be meaningful, it is key to understand the advantages and disadvantages of the ocular model, the target tissue, and therapeutic objectives.

The second speaker, Joshua T. Bartoe, DVM, MS, DACVO, of Northern Biomolecular Research Inc., shared a broad overview of basic and advanced ocular anatomical and functional examinations and guided the audience on a fascinating trip through the different ocular examinations and equipment. Dr. Bartoe detailed the basic requirements for GLP studies including slit-lamp, indirect ophthalmoscopy, tonometry, and electroretinography. Finally, the advanced examination using CLSM, OCT, fluorescein angiography, and VEP was discussed to answer specific study-related and regulatory questions.

The third speaker, Helen Booler, PhD, of Genentech Inc., focused in detail on the evolving strategies for histopathological evaluation of ocular tissue. Dr. Booler shared a few examples based on a recent interaction of the US Food and Drug Administration with a working group of sponsors and pathology consultants. The speaker emphasized the importance of number and sample site as well as sampling ocular adnexa tissue for histopathology evaluation of ocular therapeutics. Finally, Dr. Booler highlighted the importance of a proactive communication between the ophthalmologist, histologist, and pathologist for an accurate identification of the test article or lesion in the eye and to correlate the in-life findings with the histopathology observations.

Finally, Brenda Smith, PhD, DABT, of Allergan illustrated the strategy for applying the learnings from systemic drug development to the preclinical development of ocular therapeutics. Dr. Smith highlighted examples of recent ocular therapeutics where the systemic, carcinogenicity, and reproductive toxicity endpoints were waived based on the low-to-negligible systemic exposure or because of formulation and vehicle limitations. In addition, Dr. Smith outlined the decision tree strategies for new molecule entities and repurposed products.

Overall, this was an excellent CE course that presented a broad overview of ocular anatomy and physiology of the eye. The speakers highlighted the modern ocular evaluation techniques and assessment strategies for new ocular therapeutics, and all of them illustrated these with examples and case studies.

This blog was prepared by an SOT Reporter and represents the views of the author. SOT Reporters are SOT members who volunteer to write about sessions and events in which they participate during the SOT Annual Meeting and ToxExpo or 2020 SOT Virtual Meeting. SOT does not propose or endorse any position by posting this article. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.

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