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Preclinical Ophthalmic Research Services

Ora’s non-GLP preclinical ophthalmic research team has extensive experience, ranging from identification and procurement of compounds to managing and executing animal efficacy, tolerability, and PK studies. Animal disease models are modified to provide a customized and accurate screening in the most efficient and cost-effective manner. We have a collaborative approach to ocular drug development through synergy with Ora’s clinical, regulatory, and CMC departments. Ora also assists with development and management of GLP toxicology programs to support regulatory filings.

Summary of Preclinical Services

DELIVERY METHODS

  • Topical eye drop
  • Intravitreal injection
  • Subconjunctival injection
  • Intracameral injection
  • Subretinal injection
  • Systemic delivery including oral, subcutaneous, intraperitoneal and intravenous

CAPABILITIES

  • Fundus imaging
  • Fluorescein angiography
  • IOP measurements
  • Optical coherence tomography
  • Electroretinograms
  • Safety, biocompatibility, and toxicity evaluations

STUDIES AND SPECIES

  • Tolerability/Irritation/Safety
  • PK/PD
  • Ocular efficacy models
  • Ocular gene therapy/gene delivery
  • Ocular implant delivery/efficacy
  • Rabbit, rat, mouse

Preclinical Ophthalmology CRO Services by Therapeutic Area

  • Short ragweed sensitization (mouse)
  • Chronic desiccation stress
    (Scopolamine/Low Humidity Chamber CAE-mouse)
  • Acute inflammatory stress
    (ConA/Low Humidity Chamber CAE-mouse)
  • Corneal wound healing (rabbit)
  • Experimental autoimmune uveitis (rat)
  • Endotoxin induced uveitis (rat)
  • Post-operative inflammation (rabbit)
  • Normotensive (rat, rabbit)
  • Optic nerve crush (rat)
  • VEGF-induced vascular leakage (rat)
  • STZ-induced diabetic vascular leakage (rat)
  • Chronic leakage model (in development)
  • Tailored to the needs of the client

Preclinical Ophthalmic Research Capabilities

  • Evaluate safety, biocompatibility, and toxicity
  • Fundus examination/imaging (Micron 3)
  • Fluorescein angiography (Micron 3)
  • IOP measurements (Tonolab)
  • OCT (Bioptogen)
  • Full-field ERGs (Diagnosys)
  • Evans-Blue Assay (EB)
  • Full report provided

Get the milestone data you need to make important decisions in the early stages of product development. Contact us to learn more about Ora’s preclinical ophthalmic research services and how we can help accelerate your product development.