Ocular Toxicology and Safety Assessment

CBI offers both exploratory proof-of-concept ocular toxicity and tolerability studies, and complete preclinical GLP toxicology and safety assessment studies suitable for regulatory submission for ophthalmic drugs, biologics, antibodies and proteins, and devices. CBI is versed in ocular toxicology studies employing stem cells, contact lens and punctal plugs as well as other surgically implanted ocular and intra-ocular devices. We have specialized techniques including OCT, ERG, tonometry, pachymetry and fundus angiography available for toxicology and pharmacology assessments.

Methods of Assessment

  • Acute, sub-chronic and chronic toxicology
  • Acute tolerability
  • Lacrimation and pupillary diameter testing
  • Range-finding
  • Sensitization

Routes of Administration

Ocular application and injection routes including:

  • Anterior and posterior chamber
  • Conjunctival or subconjunctival
  • Intrastromal
  • Intra and transclera
  • Intravitreal
  • Lacrimal glands
  • Ocular implants and devices
  • Periocular
  • Retrobulbar
  • Subretinal
  • Subtenon
  • Topical

Study Types

  • Contact lens toxicology
  • Contact lens toxicity
  • Lacrimation assessment
  • Multiple-dose subacute and chronic ocular toxicity
  • Ocular gene therapy and regenerative medicine studies
  • Ocular implant toxicology
  • Ocular irritation, tolerability and sensitization studies
  • Ocular sensitization
  • Ocular toxicology
  • Punctal plug toxicity
  • Punctal plug toxicology
  • Pupillary diameter testing
  • Single-dose ocular toxicity
  • Tolerability testing

Capabilities

  • Angiograms
  • Electroretinogram (ERG)
  • ELISA
  • Flow cytometry
  • Funduscopy
  • IHC and histopathology
  • Slit lamp exam (SLE)