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

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  • 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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Posted In: BiotechLong IdeasNewsPenny StocksHealth CareSmall CapMoversTrading IdeasGeneralBriefsPhase 3 TrialWet AMD
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