A small European biotechnology start-up company developing a novel approach in the treatment of serious ophthalmic diseases needed support with their first FDA filing for a combination therapy (biologic + medical device) to initiate a Phase 2 trial in the U.S. They provided EVERSANA a tight time frame; dealing at the same time with technical issues that were slowing down the process. It seemed an impossible task.
• Application submitted in stipulated time.
• A comprehensive filing submitted that did not raise any potential clinical hold questions with the IND.