Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2
- Company reports no anticipated COVID-19 impact on NORSE 1, its first registration clinical trial evaluating ONS-5010, an investigational ophthalmic formulation of bevacizumab, to treat wet AMD
- Risk mitigation strategies being developed for possible one- to three-month delay related to COVID-19 for NORSE 2, the Company’s second registration clinical trial for ONS-5010 to treat wet AMD, depending on local emergency conditions
All clinical and chemistry, manufacturing and control (CMC) activities are currently active for both NORSE 1 and NORSE 2, registration clinical trials evaluating ONS-5010 for treatment of wet age-related macular degeneration (wet AMD). The Company has confirmed with the Ophthalmic Division of the
NORSE 1 completed enrollment in
NORSE 2, which commenced enrollment in
“In these unprecedented times across the globe, the safety of the patients and medical staff engaged in our NORSE 1 and NORSE 2 clinical trials is our top priority. We are fortunate enough not to expect any delay in our NORSE 1 clinical trial and anticipate reporting data from the study in August of this year, as planned. We want to share our deepest appreciation to all medical staff and patients for their ongoing participation in this important clinical work,” said
About ONS-5010 / LYTENAVA™
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. ONS-5010 is currently being evaluated in two registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication. If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat approved retinal diseases. The Company currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally.
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 its plans for filing a BLA for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its commercialization plans for ONS-5010, expected data read-out dates for NORSE 1, and the impact of the COVID-19 pandemic on its ongoing ONS-5010 clinical trials. 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, the uncertainty regarding the COVID-19 pandemic and its duration, 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
Media Relations Specialist
LaVoie Health Science
Chief Executive Officer
Source: Outlook Therapeutics, Inc.