Anti-inflammatory

Exploring an Anti-inflammatory Candidate? We can help.

Ora’s ocular models have been supporting companies for decades, helping them move their product through the clinic quickly. This translates well when exploring anti-inflammatory candidates. Let us show you how!

The Ora team has translated the reliable, validated Ora-CAC® model into an approach to help you with your indication expansion and anti-inflammatory product development efforts. We use the eye as a surrogate for inflammation in a proprietary ocular allergic model to evaluate anti-inflammatory products. Using in-vivo confocal microscopy of the ocular surface, Ora has the ability to show – in real time – the impact a product is having on the various stages of ocular inflammation.

Option 1: Current Route of Translating

In this case, you go straight into the clinical trials process.

This is beneficial because you can get to a decision quickly on if your product has efficacy in inflammation. Within 12 – 24 months, depending on formulation and animal studies, you can get into the clinic.

If you find efficacy in the POC, then we can work together on a preclinical and clinical approach to change the route of administration to a new administration route.

Services include:

  • Regulatory support – US, Japan, UK, and EU
  • KOL development
  • Protocol development: design of clinical trials and sample size determination
  • Market size justification / market access / pricing and reimbursement

Option 2: New Route of Administration

If you change the route of administration at the beginning of the process, you must first do a preclinical toxicology program before you go into the clinical trials process.

Services include:

  • Formulation support
  • Preclinical ocular toxicity screening
  • Regulatory support – US, UK, and EU
  • Protocol development: design of clinical trials
  • Market size justification / market access / pricing and reimbursement