Preclinical

Ora’s preclinical team has extensive experience, ranging from identification and procurement of compounds to managing and executing animal efficacy, safety, 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 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.

Preclinical Services – Early Development

  • Topical eye drop
  • Intravitreal injection
  • Subconjunctival injection
  • Intracameral injection
  • Subretinal injection
  • Systemic delivery including oral, subcutaneous, intraperitoneal, and intravenous
  • Tolerability/Irritation/Safety studies
  • Rabbit, rat, mouse, NHP
  • Ocular tissue penetration and distribution
  • Rabbit, rat, mouse, NHP

Preclinical 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, NHP)
  • Optic nerve crush (rat)
  • VEGF-induced vascular leakage (rat)
  • STZ-induced diabetic vascular leakage (rat)
  • Chronic leakage model (NHP; in development)
  • Tailored to the needs of the client

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