ONS-5010 is an innovative mAb therapeutic currently enrolling patients in a clinical trial outside the United States designed to serve as the first of two adequate and well controlled studies evaluating ONS-5010 for wet AMD.
We plan to submit an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, in the first quarter of calendar 2019 and the U.S. portion of the second study is scheduled to begin at that time. Our ONS-5010 wet AMD clinical program was reviewed at a successful end of Phase 2 meeting with the FDA conducted in 2018. If the program is successful, it will support our plans to submit for regulatory approval in multiple markets in 2020.
Because there are no approved bevacizumab products for the treatment of retinal diseases, we are developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.