For the latest updates on how we are managing changes due to COVID-19 please click here. Ocular Surface and Anterior Segment Anti-inflammatory 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 Ora Headquarters 300 Brickstone Square Andover, Massachusetts 01810 United States of America Contact Us tel: (978) 685-8900 fax: (978) 689-0020 Stay in Touch Follow us on social media Copyright © 2020 Ora, Inc. All Rights Reserved. Privacy Policy Site Map Contact Us Ora, Inc websites use cookies. By continuing to browse the site you are agreeing to our use of cookies. For more details about cookies and their use, please see our Privacy Policy. CONTINUE