Considerations for Ocular Toxicologic Pathology in Nonclinical Studies for the Development of Intraocular Biologics to Treat Glaucoma and Secondary Neurodegeneration
- Authors: Vladimir Bantseev1, Rachel N. Andrews2
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View Affiliations Hide Affiliations1 Therapeutic Area Lead for Ophthalmology, Safety Assessment Toxicology, Genentech Research and Development, A Member of the Roche Group, 1 DNA Way, MS# 441A, South San Francisco, CA 94080, USA 2 Therapeutic Area Lead for Ophthalmology, Safety Assessment Toxicology, Genentech Research and Development, A Member of the Roche Group, 1 DNA Way, MS# 441A, South San Francisco, CA 94080, USA
- Source: Research Protocols for Ophthalmic Disease Mechanisms and Therapeutics: Glaucoma - Ocular Hypertension , pp 462-472
- Publication Date: August 2025
- Language: English
Considerations for Ocular Toxicologic Pathology in Nonclinical Studies for the Development of Intraocular Biologics to Treat Glaucoma and Secondary Neurodegeneration, Page 1 of 1
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Ocular hypertension (OHT) associated with many forms of glaucoma can be treated by traditional pharmaceutical drugs, surgery, and aqueous humor microshunt implants. More recently, however, attempts have been made to introduce gene and cell therapies and even biologics to treat OHT and IOP-independent glaucomatous optic neuropathies with various degrees of success. In order to ensure the safety of any test agent or product, it is imperative that a set of toxicological studies be conducted on the compound or test agent. Accordingly, in this section/chapter, we provide considerations for toxicologic pathology evaluation of intraocular biologic therapeutic candidates to treat glaucoma. These types of investigations can be applied not only to biologics but, with appropriate modifications, to any entity that is to be introduced into animals and perhaps in humans in due course as part of proof-of-concept studies.
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