Outlook Therapeutics Inc (NASDAQ:OTLK) completed the evaluation study of ONS-5010/LYTENAVA with the first final visit of the last patient.
Completes two clinical trials
In the open-label study, the company evaluates the safety of bevacizumab-vikg to cure retinal diseases. With the final visit of the patient, the company now completed the two planned clinical studies out of the three trials of ONS-5010 / LYTENAVA wet AMD BLA.
Outlook Therapeutics enrolled 197 patients in the open-label safety trial. It administers anti-VEGF drug in the 4-month trial for the treatment of DME (diabetic macular edema), wet AMD, and BRVO (branch retinal vein occlusion).
Clinical data expected in Q2 2021
The patients are administered three monthly doses of bevacizumab-vikg. Outlook Therapeutics expects to report the results of the clinical trial in Q2 2021. The company will include this data in the package for the support of the Biologics License Application (BLA) in the US for wet AMD in Q4 2021.
CFO, CEO, and President of Outlook Therapeutics, Lawrence A. Kenyon said the patients and clinicians played a vital role in completing the safety trial on schedule despite the ongoing coronavirus pandemic. The NORSE Three clinical trial is important for the ONS-5010 RP (registration program). It now focuses on NORSE TWO Phase 3 clinical trial of ONS-5010 to cure wet AMD. The company also plans for BLA submission following the successful completion of the study.
Expects to file BLA with FDA
On completing the pivotal efficacy and safety trial and open-label safety study, Outlook Therapeutics now prepared for the submission of BLA with the US FDA. The company will be eligible for marketing exclusivity for the drug ONS-5010 for 12 years on getting FDA approval.
Commercial distribution
Outlook Therapeutics is planning for patient and physician outreach and distribution of ONS-5010. On receipt of the FDA nod, the company expects wide acceptance for the drug from clinicians and payors worldwide because of its economical and improved safety profile. It will be the first drug option for step edit in the US to treat retinal diseases.
Outlook Therapeutics also obtained accords on three SPAs (Special Protocol Assessments) from the US FDA to carry out three registration clinical studies. In these clinical trials, the drug ONS-5010 will be evaluated for the treatment of BRVO and DME. The company will commence the initial study in the later part of 2021.
