The likelihood of approval (LoA) of Outlook Therapeutics ’ (NASDAQ:OTLK) Phase III Lytenava (bevacizumab-vikg) in diabetic macular edema (DME ) rose 7 points, with its prospects in branch retinal vein occlusion (BRVO) jumping by 10 as of 6 April, according to GlobalData’s LoA data. The increase was triggered after Outlook’s NORSE 3 trial in wet-AMD reported no unexpected safety events.
Topline results from NORSE 3 demonstrated bevacizumab-vikg had a similar safety profile to Roche ’s Avastin (bevacizumab), as found in the 2011 CATT study. NORSE 3 reported no serious adverse events (SAEs) associated with the treatment. While 20 out of 197 patients suffered an AE in the study eye, these were associated with administration rather than treatment, according to a 31 March company media release. The safety outcomes were the frequency and incidence of AEs and changes in safety parameters, said Outlook.
The anti-VEGF recombinant monoclonal antibody (mAb) previously had an LoA of 37% for DME and 11% for BRVO. Based on GlobalData’s analysis using a combination of machine learning and a proprietary algorithm, the LoA for DME has risen to 44%, while bevacizumab-vikg’s chances in BVRO have increased to 21%. Anti-VEGFs work by targeting the VEGF protein that promotes abnormal blood vessel growth.
On 31 March, this news service reported that Outlook’s registrational Phase III NORSE 2 trial of bevacizumab-vikg in wet-AMD would reach superiority over its comparator, Roche’s Lucentis (ranibizumab), and likely get approval. However, a poor trial design that underdosed the control arm would limit physicians’ confidence and in turn uptake.
Sean Rai-Roche is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.