Ocular Toxicology

ToxStrategies scientists, including board-certified toxicologists, have unique and extensive experience in the field of ophthalmology and ocular toxicology. With our diverse experience, we can help design non-clinical ocular toxicology protocols and oversee in vivo toxicology studies for new ocular products in development.

Selected examples:

  • Development of ocular pharmaceuticals, biopharmaceuticals, and gene therapies
  • Evaluation of contract research organizations (CROs) with expertise in opthalmic study conduct
  • Toxicology study design and study monitoring for topical ocular, intravitreal, subretinal, and other opthalmic routes of administration
  • Knowledge and study-appropriate application of ophthalmic study endpoints. such as Hackett- McDonald or McDonald-Shaddock scoring, tonometry, pachymetry, slit-lamp examinations, ophthalmoscopy, electroretinography, and others
  • Knowledge and study-appropriate application of imaging techniques such as optical coherence tomography, specular microscopy, and fluorescein angiography
  • Evaluation and interpretation of ocular immunogenicity endpoints
  • Data analysis and interpretation of ophthalmic exam results, considering factors relative to ocular disease, targets, and route of administration in large-cohort GLP and non-GLP non-clinical animal studies with unilateral or bilateral dosing in rat, rabbit, dog, and non-human primate
  • Review and preparation of briefing packages, INDs, NDAs, and other regulatory documents
  • Preparation of study waivers for selected systemic studies when ocular dosing studies have low systemic exposure