Outlook Therapeutics Completes Patient Enrollment for NORSE 1 a Phase 3 Clinical Trial for ONS-5010 in Wet AMD
“We are pleased with the building momentum in our two ongoing Phase 3 clinical trials for ONS-5010, including completing enrollment in NORSE 1. Achieving this milestone keeps us on track for our goal to submit ONS-5010 for regulatory approval in
NORSE 1 has enrolled a total of 61 patients at 9 sites in
“The NORSE 1 study design was confirmed in our
If the ONS-5010 clinical program is successful, it will support the Company’s plan to submit for regulatory approval in multiple markets in 2020. If approved, ONS-5010 has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off label use of Avastin is currently estimated to account for at least 50% of all wet AMD prescriptions in
ONS-5010 is an ophthalmic formulation of bevacizumab to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases. Bevacizumab is a full length humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody that inhibits VEGF and associated angiogenic activity. The Company’s ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated as a single use vial for IVT injection. By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance of tumor blood vessels.
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about the Company’s plans for seeking regulatory approval for ONS-5010, enrollment in clinical trials for ONS-5010, the timing of announcing top line data from such trials, the outcome of such clinical trials, the ability of ONS-5010 to mitigate risks associated with off-label use of Avastin and provide benefits to patients, payors and physicians. Although the Company believes that it has a reasonable basis for forward-looking statements contained herein, they are based on current expectations about future events affecting the Company and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing pharmaceutical product candidates, risks of conducting clinical trials, and risks in obtaining necessary regulatory approvals, as well as those risks detailed in the Company’s filings with the
For additional details on the Company’s financial performance during the quarter, please see the Company’s filings with the
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Source: Outlook Therapeutics, Inc.