Ocular Toxicology Services

Scientists in sterile lab coats and caps perform testing under biosafety cabinets and microscopes in a cleanroom for ocular toxicology service.

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.
  • 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
eBook cover promoting a preclinical ocular gene therapy reference guide with emphasis on ocular toxicology, featuring an abstract eye graphic.

Preclinical Ocular Gene Therapy Reference Guide

A Pharmaron service overview document outlining preclinical and CMC support for AAV-based therapies, including study design, regulatory submission, and manufacturing.

Preclinical & CMC Services for AAV-Based Therapies

Pharmaron brochure showcasing ocular testing services with scientific imagery, digital eye graphics, and a PDF download prompt.

Ocular Testing Services: Therapeutic Development

Service overview flyer highlighting Pharmaron's ocular efficacy, PK, and toxicology capabilities and services, with a "Download Service Overview" button.

Ocular Efficacy, PK and Toxicology Services