ONS-5010, an Investigational Ophthalmic Formulation of Bevacizumab — Clinical Progress

NORSE 1

NORSE 1 is the first of two adequate and well-controlled registration clinical trials in our Phase 3 program for ONS-5010 to treat wet AMD. It is underway outside the United States in Australia and is expected to be completed in Q3:2020 (enrollment completed in August 2019). It is a superiority trial comparing ONS-5010 with an alternate dosing regimen of ranibizumab (LUCENTIS®).

NORSE 2

NORSE 2 is the second of two adequate and well-controlled registration clinical trials in our Phase 3 program for ONS-5010 to treat wet AMD. It is underway in the United States and is expected to enroll at least 220 patients who will be treated for 11 months. We expect to complete NORSE 2 in Q2:2021. NORSE 2 also is a superiority trial comparing ONS-5010 with an alternate dosing regimen of ranibizumab (LUCENTIS®).

NORSE 3

NORSE 3 is an open-label safety study that will be conducted to ensure the adequate number of safety exposures to ONS-5010 are available for the initial regulatory filings.

NORSE 4

NORSE 4 is a planned clinical trial that will evaluate ONS-5010 for use in treating BRVO.

NORSE 5 & NORSE 6

NORSE 5 & NORSE 6 are planned clinical trials that will evaluate ONS-5010 to treat DME.

Regulatory Approval Plans

If our clinical program is successful, it will support our plans to submit for regulatory approval of ONS-5010 in multiple markets. Because there is currently no bevacizumab approved for ophthalmic indications in the United States, we will file ONS-5010 with the FDA as a new BLA under the PHSA 351(a) regulatory pathway, not as a biosimilar.