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, 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, intravitreal injection, subconjunctival injection, periocular injection, intracameral, subretinal, intrascleral, trans-scleral, intrastromal, subtenon, retrobulbar, intracameral, implant or device.
Comparative Biosciences has ocular toxicology expertise in the following areas:
- Ocular irritation studies
- Acute ocular tolerability
- Single-dose ocular toxicity
- Multiple-dose ocular toxicity
- Lacrimation assessment
- Pupillary diameter testing
- Ocular pharmacokinetics
- Ocular pharmacology
Acute Tolerability Testing
These studies include single or multiple dose short-term studies to assess acute effects of topical application of test article on the eye. A typical study would be:
Acute Single Dose Study-Typical Study Design
- Rabbits, at least 3 per group recommended, vehicle, three doses of test article and positive control
- Topical or Intraocular application of test article
- Draize Scoring at 5 min, 60 min, 1, 2 and 3 days (4 and 7 days if necessary)
Subchronic and Chronic Toxicity
These studies include multiple dose long-term studies to access sub-chronic to chronic effects of topical application of the test article on the eye. Rabbits and mini-pigs are commonly used.
Multiple Dose Study-Typical Study Design
- Routes include topical ocular application, intravitreal injection, subconjunctival injection, periocular injection, intracameral, subretinal, intrascleral, trans-scleral, intrastromal, subtenon, retrobulbar, intracameral, implant or device.
- Parameters include:
- Daily draize score, food consumption, clinical observations
- Weekly McDonald-Shadduck score, ocular examination as relevant
- Toxicokinetics
- Complete necropsy, clinical pathology, organ weights and ocular histopathology, complete organ histopathology
- Funduscopy, pachymetery, IOP, slit lamp, assessments as appropriate to test article
Lacrimation and Pupillary Diameter Studies
Lacrimination
These studies assess the activity of test articles with regard to tear production.
- NZW rabbits, 3/group, vehicle, three doses of test article and positive control (pilocarpine)
- Tear production measured by Schirmer Tear Test and/ Tear Breakup Test
- Quantity of lacrimation assessed at 5 min intervals over 1 hour
Pupillary Diameter
These studies assess the activity of test articles on papillary diameter.
- NZW rabbits, at least 3 per group recommended, vehicle, three doses of test article and positive control (pilocarpine)
- Pupillary diameter measured by graduated ruler