ONS-5010 — Clinical Progress
Clinical Study 1
The first clinical study for ONS-5010 is being conducted outside of the United States and is designed to serve as the first of two adequate and well controlled studies for wet AMD.
Clinical Study 2
The U.S. portion of the second study is scheduled to begin in early 2019 upon the submission of an investigational new drug (IND) application. Outlook Therapeutics’ wet AMD clinical program was reviewed at a successful end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted earlier in 2018.
Regulatory Approval Plans
If the program is successful, it will support the Company’s plans to submit for regulatory approval in multiple markets in 2020. The Company is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.
Results of Prior Studies
Previously, ONS-5010 met the primary and secondary endpoints in a 3-arm single-dose pharmacokinetic (PK) Phase 1 clinical trial. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125% when compared to both U.S.- and EU-sourced Avastin® reference products.