Outlook Therapeutics Presents NORSE TWO Phase 3 Pivotal Safety and Efficacy Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at the Retina Subspecialty Day, American Academy of Ophthalmology (AAO) 2021 Annual Conference
- NORSE TWO showed highly statistically significant, clinically relevant results consistent with historical ophthalmic bevacizumab data
- Data support planned BLA submission with
The data presentation “Safety and Efficacy Results of ONS-5010, as Ophthalmic Bevacizumab, Phase 3 Pivotal Study of Monthly Intravitreal OS-5010 in Subjects with Wet AMD (NORSE TWO)” was given during Section X: Late Breaking Developments, Part II by
“If approved by the FDA, ONS-5010 will become the first and only on-label ophthalmic bevacizumab, which is very significant for thousands of patients needing anti-VEGF treatments to control their wet AMD,” said
The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the
The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results:
- 41.7% (p = 0.0052) ONS-5010 subjects gained ≥ 15 letters of vision
- 56.5% (p = 0.0016) ONS-5010 subjects gained ≥ 10 letters of vision
- 68.5% (p = 0.0116) ONS-5010 subjects gained ≥ 5 letters of vision
- ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA
Results from NORSE TWO also demonstrated that ONS-5010 ophthalmic bevacizumab has a strong safety profile. In findings that are consistent with historical bevacizumab data reported in prior research, in all three ONS-5010 registration trials there was only one ocular inflammatory adverse event, which was treated topically and resolved without sequelae. The safety findings continue to support minimal ocular inflammation and safety signals consistent with what was previously reported in the 2011 CATT trial (
“With the positive results from NORSE TWO, we are confident that, if approved, ONS-5010 has the potential to become a valuable new tool in the armamentarium of therapies for wet AMD. If approved as the first on-label ophthalmic formulation of bevacizumab, ONS-5010 will enable patients to benefit from wider access and provide an attractive alternative for anti-VEGF treatment of wet AMD,” added C. Russell Trenary III, President and CEO of
Outlook Therapeutics’ clinical program investigating ONS-5010 ophthalmic bevacizumab to treat wet AMD consists of three clinical trials – NORSE ONE, NORSE TWO, and NORSE THREE – all of which have now been completed. Based on the strong data from this clinical program,
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
ONS-5010 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 pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of abnormal new blood vessels and promotes leakage from these vessels, leading to retinal edema and hemorrhage. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF injection therapy treats the vision-threatening leakage and hemorrhage as well as blocks the growth of the abnormal blood vessels. 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, among others, statements about ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, including expectations of market exclusivity, the timing of BLA submission and commercial launch of ONS-5010 and plans for regulatory approvals in other markets. Although
LaVoie Health Science
Chief Executive Officer
Source: Outlook Therapeutics, Inc.