ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other approved retinal diseases.
The study design for our Phase 3 clinical program to evaluate ONS-5010 as an ophthalmic formulation of bevacizumab was reviewed and agreed upon in an end-of-Phase 2 (EOP2) meeting with the FDA in April 2018. ONS-5010 is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 & NORSE 2) and is expected to be filed with the FDA as a new BLA for this ophthalmic indication. Additionally, we intend to commence clinical trials for ONS-5010 in DME (NORSE 5 & NORSE 6) and BRVO (NORSE 4).
Because there are no bevacizumab products currently FDA-approved for ophthalmic indications, physicians wishing to treat wet AMD or other retinal diseases with bevacizumab have had to use repackaged bevacizumab from compounding pharmacists. Such products can have known safety, potency, sterility and availability issues. If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab for retinal indications.