Ocular Toxicology Studies
Charles River performs safety and efficacy assessments for all ocular indications. Ocular effects of compounds administered by other routes, such as oral, can also be characterized. These ocular toxicology studies can be conducted under GLP or non-GLP conditions, either as stand-alone studies or as part of general and specialty toxicology programs. Non-GLP pilot or proof-of-concept studies, as well as in vitro ocular irritancy evaluations are also available for your early research. Our on-site ACVO board-certified veterinary ophthalmologists have experience with both rodents and nonrodents using small molecules, biologics, cell therapy, gene therapy, implants, and transplants.
Need support for your ocular drug products?
With the most experieced ocular pathology team in the contract research industry, our knowledge and expertise to perform specialized pathological assessmennts of ocular tissues will support any ocular toxicology study needs that clients have. This support includes routine paraffin or cryo-sectioning, immunohistochemistry, and electron microscopy.
Case Study: Evaluating Multiple Vectors in a Single Eye
A custom surgical technique to create four independent subretinal injection sites within a single eye for a gene vector.
Examinations and Services
STUDY DOSING ROUTES
- Specular microscopy for noninvasive, in vivo evaluation of the corneal endothelium
- Tonometry (IOP) evaluations
- Enhanced microscopic evaluation
- Ocular histopathology
- Quantitative autoradiography (2D and 3D)
- Ocular and systemic tissue distribution (detailed ocular tissue dissections; radioisotope-labeled, LC-MS/MS, ELISA, PET, SPECT)
- Corneal fluorescein staining
- Schirmer tear/phenol red thread testing
- In vitro corneal opacity and permeability
PRECILNICAL EXAMINATIONS & SERVICES
- Electroretinography (ISCEV, custom protocols, and VEP)
- Spectral domain optical coherence tomography (SD-OCT; anterior and posterior) and retinal layer segmentation
- Pachymetry (corneal thickness)
- Digital fundus photography/video
- Confocal scanning laser ophthalmoscopy (CSLO; multiple image modes – infrared and tomography for 3D images)
- Fundus autofluorescence
- Fluorescein angiography (FA)
- Indocyanine green angiography (ICG)
- Aqueous/vitreous humor collections and biomarker quantification
- Slit-lamp biomicroscopy
- Indirect and direct ophthalmoscopy
- Streak retinoscopy
- Draize test
- Ocular reflexes
Pharmaceutical Formulation Development
Frequently Asked Questions (FAQs) for Ocular Toxicology Research
What is ocular toxicity?
Ocular toxicity is characterized by one or more adverse changes that affect the structure or function of the eye following application of a substance, drug, or device directly on or in the eye or an alternate site in the body distant to the eye. In the most severe forms, ocular toxicity may cause ocular pain and/or irreversible vision loss. These types of studies follow specific regulatory guidance, (e.g., Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route provided by the FDA).
What is a nonclinical ocular model?
A nonclinical ocular model may be either an in vitro system or a purpose-bred animal that provides detailed information to research scientists about the efficacy and/or safety of a substance, drug, or device developed to address a specific human ocular condition. Biotechnology companies can partner with preclinical cro that conducts ocular toxicology studies to evaluate these models and the therapies they are developing.
What is cell therapy?
Cell therapy involves the delivery of in vitro cultured cells to a chosen tissue in the body to supplement or replace a patient’s own irregular cell population, commonly in attempt to eliminate or modify a disease condition.