Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
- First subjects have been enrolled in supplemental open-label safety study
- Study being conducted to ensure the requisite number of patient exposures to ONS-5010 to support new BLA filing to the FDA in 2021
- ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD and other retinal diseases, on track to report pivotal data in mid-2021 from ongoing, fully enrolled Phase 3 registration trial
The open-label safety study is being conducted to ensure that an adequate number of safety exposures to ONS-5010 / LYTENAVA™ (bevacizumab-vikg) are available to support Outlook Therapeutics’ initial Biologics License Application (BLA) filing for wet AMD with the
“The initiation of this open-label safety study, the third clinical trial in our wet AMD program, is an important step in our overall development plan for ONS-5010. This study is intended to ensure that enough patients have been treated with ONS-5010 in our streamlined clinical program to support submission for a new BLA,” said
The data from this supplemental safety study, the results from a previously completed clinical experience trial, which demonstrated anticipated safety and efficacy as well as positive proof-of-concept, and the data from the ongoing, fully enrolled pivotal Phase 3 trial will form the complete data set required for a potential new BLA filing for the treatment of wet AMD in the second half of 2021.
While unapproved repackaged IV bevacizumab from compounding pharmacies is already widely used in treating retinal diseases, ONS-5010, if approved, will be the first on-label injectable ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD and other retinal diseases; it will offer a new approved anti-VEGF treatment option across the spectrum of retinal care, currently estimated to be over
Commercial launch planning for ONS-5010 is ongoing, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. With an enhanced safety and cost-effectiveness profile,
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
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 a Phase 3 clinical trial for wet AMD and, if successful, is expected to be filed with the FDA as a new BLA for this ophthalmic indication under the 351(a) regulatory pathway. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.
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. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. 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.
If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat retinal diseases.
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 timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, the timing of BLA submission and sufficiency of exposures to support such submission, statements about commercial launch of ONS-5010, the timing of entry into a strategic partnership and definitive agreement with a global ophthalmic company, including its ability to do so, and plans for regulatory approvals in other markets. Although
LaVoie Health Science
Chief Executive Officer
Source: Outlook Therapeutics, Inc.