Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
- Full enrollment of 195 subjects in NORSE THREE achieved in less than one month, significantly ahead of schedule
- All planned clinical trials for ONS-5010/LYTENAVA™ BLA for wet AMD now fully enrolled or completed
- Pivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 (NORSE TWO) with new BLA filing expected in second half of 2021
The open-label safety study enrolled 195 subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet age-related macular degeneration (AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study are receiving three monthly intravitreal (IVT) doses of ONS-5010/LYTENAVA™. The data from this study will be included in the complete data package to support the planned Biologics License Application (BLA) for wet AMD, on schedule for submission to the
“I am delighted to see the enthusiasm for ONS-5010 that our clinical trial investigators have shown and their ability to rapidly enroll patients. The expedited manner in which enrollment was completed strengthens our confidence that an FDA-approved ophthalmic formulation of bevacizumab represents a significant unmet need in the ophthalmic community,” said
While unapproved repackaged IV bevacizumab from compounding pharmacies is already widely used in treating retinal diseases, ONS-5010, if approved, will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD. It will offer a new, approved treatment option for wet-AMD, in the estimated
“On behalf of the entire
In addition to the planned BLA filing in
Commercial launch planning for ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement, remains ongoing. 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. 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.
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 “expect,” “will,” “could,” “may,” “might,” “should,” “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, the timing of BLA submission, sufficiency of exposures and clinical trials conducted to support such submission, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, 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
Assistant Vice President
Chief Executive Officer
Source: Outlook Therapeutics, Inc.