ToXchange Developing Therapeutics for Ocular Indications: A 20/20 View
SOT Virtual CE Course: AM03
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Chair(s): Kathleen Krenzer, Iuvo BioScience; and Hiromi Hosako, Alcon.
Primary Endorser:
Ocular Toxicology Specialty Section
Other Endorser(s):
Biotechnology Specialty Section; Comparative Toxicology, Pathology, and Veterinary Specialty Section
No longer are eye drops the only way to treat the eye; the emergence of novel therapeutic and development approaches for ocular indications has impacted how we design toxicology assessments, select species, and perform toxicity evaluations. Additionally, the structural complexity of the eye as well as the unique aspects of ocular dose-administration routes require continued refinements of ocular evaluation techniques and assessment strategies. The goal of this course is to provide toxicologists with a broad overview of highly specialized ocular anatomy, current ophthalmic diagnostic techniques, evolving histopathological assessment strategies, and thought-provoking ocular drug development strategies, including case studies. The first speaker will open the session with an detailed overview of ocular anatomy complexity, focusing on unique features of the eye and critical anatomical and physiological features that may influence or impede a drug's efficacy and safety in human patients. The speaker also will discuss novel routes of drug administration in ocular drug development. The second presentation will tune in to gold-standard, in-life ophthalmic diagnostic techniques with selected case examples showing how modern ocular diagnostic equipment can be used to prove multifactorial questions. This presentation also will touch upon recent efforts at harmonization of ocular finding nomenclature and clinical record-keeping lexicon in preparation for SEND (Standard for Exchange of Nonclinical Data) requirements dictating reporting of ocular toxicology studies. The third talk will focus on evolving strategies for histopathological assessment of ocular tissues, which will include key points to consider when processing the eye to ensure a thorough examination of key structures of the globe as well as the effect of factors such as the route of administration and the formulation or character of the therapeutic candidate on effective examination of the eye. The last presentation will highlight unique nonclinical safety challenges and considerations during ocular drug development using case studies to push our assumptions of what is the best way to evaluate the safety of ophthalmic therapeutics.
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Developing Therapeutics for Ocular Indications: A 20/20 View
Do Animals See 20/20? The Spectrum of Ocular Anatomy and Physiology in Animals.—S. Eaton. University of Wisconsin–Madison, Madison, WI.
Getting the 20/20 Read: Clinical Evaluation Techniques for Ophthalmic Toxicology.—J. T. Bartoe. Northern Biomedical Research Inc., Norton Shores, MI.
20/20 under the Scope: Evolving Strategies for Histopathological Assessment of Ocular Tissues.—H. Booler. Genentech Inc., South San Francisco, CA. Sponsor: K. Krenzer
Using 20/20 Hindsight to Set the Course for Considerations in the Preclinical Development of Ocular Therapeutics in the Future.—B. Smith. Allergan, Irvine, CA.
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