Translation of a Crosslinked Hyaluronic Acid Gel for Corneal Repair from the Bench to Veterinary and Human Medicine

摘要

A brief outline of the process taken from product concept to clinical studies for this crosslinked modified HA is shown below. Early discussions with the FDA, both on the veterinary and human side, were critical to garnering medical device designations, thereby determining the path required to eventual commercial launch. The process to veterinary launch was relatively simple - product development and manufacturing scale-up were the most complicated, and regulatory hurdles were minor. Moving to the human market is more complicated, due to regulatory and reimbursement aspects. The most important factor to the FDA is safety, necessitating additional manufacturing controls and validations, as well as ISO 10993 studies. Having prospective human clinical data and a wealth of animal data, we are moving forward through the clearance process with the FDA, including additional pilot and pivotal clinical trials with particular indications for use.