Ocular Toxicology Services
Ocular Toxicology Services
Pharmaron provides a complete suite of toxicology services to ensure the safety of your ophthalmic products. As a GLP-compliant preclinical CRO, we specialize in designing and carrying out toxicology programs for a wide range of therapeutic candidates, helping you move your therapies toward the clinic with confidence.
Extensive experience with various products, including:
- Small molecules and biologics
- Cell therapies (e.g., iPSC, RPE)
- Gene therapies (e.g., AAV, plasmids)
- Ocular devices and implants
Our services go beyond standard assessments, incorporating a full range of post-study capabilities to provide a complete picture of your product’s effects. This includes:
- Ocular Dissections and Histopathology: Detailed dissections and microscopic analysis of ocular tissues to evaluate changes at a cellular level.
- Clinical Pathology: Complete clinical pathology services to assess systemic impacts.
Capabilities
- Full Panel Tissue Collection: Meticulous tissue collection for further analysis.
- Biodistribution: Utilizing PCR or IHC to track the distribution of gene or cell therapies, including expression pattern or integration of cell product.
- Bioanalytical Platforms: Employing advanced methods like LC-MS and ELISA for precise drug concentration and metabolite analysis.
- Biomarker Assays: Measuring key biomarkers using platforms such as ELISA and MSD.
Clinically Relevant Toxicology Evaluation
Dose Routes
Anterior
- Topical
- Intrastromal
- Intracameral
Posterior
- Intravitreal
- Subretinal
- Suprachoroidal
Peri-ocular
- Eyelid
- Subconj.
- Sub-tendon
Core Evaluation
Ophthalmic Exams
- Slit-lamp
- Indirect
- Board-cert ophthalmologist
Intraocular Pressure
Optical Coherent Tomography
- Cornea (AnterionTM, topography)
- Retina
- SD-OCT
Electroretinography
- Full-Field
- Pattern
- Scotopic/photopic
- Multifocal
Enhanced Assessments
Anterior Chamber
- Slit-lamp Photo
- Pupillometry
- Pachymetry
- Specular Microscopy (CECD)
- Gonioscopy
- Tonography
- Ultrasound (UBM)
- Fluortron
Posterior Chamber
- Color fundoscopy
- Fundus autofluorescence
- Fluoroscein angiography
- Optokinetic response (rodents)
- Visual evoked potential (VEP)
Toxicology End Points
Necropsy
- Whole globe collection/dissection
- Systematic tissue collection
- Organ Weights
- Macroscopic observations
Histopathology
- H&E
- IHC/IF
Clinical Pathology
Biodistribution
- LCMS
- PCR
- ELISA
Preclinical Ocular Gene Therapy Reference Guide
Preclinical & CMC Services for AAV-Based Therapies
Ocular Testing Services: Therapeutic Development
Ocular Efficacy, PK and Toxicology Services
