Ocular Toxicology and Safety Assessment
Comparative Biosciences, Inc. (CBI), a premier ocular toxicology CRO, offers both exploratory proof-of-concept toxicity and tolerability studies, and complete preclinical GLP Toxicology and Safety Assessment Studies suitable for regulatory submission for ophthalmic drugs, biologics, and devices. Ocular toxicity assessments include a range of Acute Tolerability, Sensitization, Range-Finding, Acute, Subchronic and Chronic Toxicology, and special tests of Lacrimation and Pupillary Diameter Testing. CBI offers a complete range of routes of ocular drug administration.
Routes include topical ocular application, and injection routes including intravitreal, subconjunctival, periocular, intracameral, subretinal, intrascleral, transscleral, intrastromal, subtenon, retrobulbar, intracameral, ocular implants or ocular devices.
CBI is versed in ocular toxicology studies employing stem cells, contact lens, punctal plugs, as well as other surgically implanted ocular and intraocular devices.
Comparative Biosciences has ocular toxicology expertise in the following areas in rodents, small animals, rabbits, ferrets, dogs and minipigs.
- Ocular irritation, tolerability and sensitization studies
- Single-dose ocular toxicity
- Multiple-dose subacute and chronic ocular toxicity
- Contact lens toxicology, pharmacokinetics and pharmacology
- Punctal plug toxicology, pharmacokinetics and pharmacology
- Ocular pharmacokinetics
- Ocular pharmacology
- Ocular implant toxicology, pharmacokinetics and pharmacology
- Lacrimation assessment
- Pupillary diameter testing
- Ocular sensitization
Tolerability Testing
These studies include single or multiple dose short-term studies to assess acute local tolerability of topical application of test article on the eye.
- Acute tolerability
- Subacute and chronic tolerability
- Ocular sensitization
Ocular Toxicology
These GLP studies include single or multiple dose toxicology studies to assess local and systemic toxicity of test articles applied to or into the eye. These studies include a full toxicologic assessment.
- Range-finding
- Acute single dose
- Subacute and chronic multi-dose toxicity
Contact Lens Toxicity
These studies include studies in which contact lenses are applied to the eye, generally to rabbits and the effects and tolerability of the lens is assessed. These studies may include toxicology studies, local irritation, and local tolerability associated with either plain or medicated lens.
Punctal Plug Toxicity
Punctal plugs are inserted into the punctum and assessed for local tolerability to the plug as well as toxicity, pharmacokinetics or pharmacology related to the test article contained within the plug.