Outlook Therapeutics Stock Surges Positive ONS-5010 Data In Wet AMD Patients

Outlook Therapeutics Inc OTLK stock is trading higher in premarket session in reaction to positive top-line results from Phase 3 NORSE TWO trial evaluating ONS-5010 / LYTENAVA (bevacizumab) for neovascular age-related macular degeneration (wet AMD).
The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best-corrected visual acuity (BCVA) at 11 months.
The trial compared ONS-5010 dosed monthly to Roche Holdings AG's RHHBY Lucentis (Ranibizumab), which was dosed monthly for the first three months followed by less frequent dosing.
In the intent-to-treat (ITT) primary dataset, 41% of patients treated with bevacizumab-vikg gained at least 15 letters, versus 23% treated with ranibizumab.
The primary endpoint was also statistically significant and clinically relevant in the secondary per-protocol (PP) dataset, at 24% with ranibizumab and 41% with bevacizumab-vikg.
A mean change in BCVA was observed with ranibizumab of 5.8 letters and 11.2 letters for the treatment arm.
The safety results demonstrated were consistent with previously reported safety results.
In NORSE TWO, there was only a single related ocular serious adverse event reported in the bevacizumab-vikg trial arm, which resolved, and no unanticipated safety signals were detected.
Outlook Therapeutics plans to submit a marketing application in Q1 of 2022.
Complete data from NORSE TWO will be presented at an ophthalmology conference in the fall of 2022 and submitted for publication in a peer-reviewed journal.
Outlook Therapeutics has begun commercial launch planning in anticipation of potential FDA marketing approval in 2022 for ONS-5010.
Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for diabetic macular edema and branch retinal vein occlusion later in 2021 or early 2022.
The management will host a conference call today at 8:00 a.m. ET.
Price Action: OTLK shares are up 26.6% at $2.87 during the premarket session on the last check Tuesday.

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