Outlook Therapeutics Inc. (OTLK), a biopharmaceutical company focused on ophthalmic treatments, on Thursday reported the positive data from its NORSE EIGHT trial evaluating ONS-5010 or bevacizumab-vikg for wet age-related macular degeneration or wet AMD.
The NORSE EIGHT trial is a key study assessing the safety and efficacy of ONS-5010, which is being developed as a potential treatment for wet AMD.
The study's 12-week results confirmed that ONS-5010 provided early and sustained anatomical improvements, with significant gains in best corrected visual acuity or BCVA.
Notably, ONS-5010 was shown to be non-inferior to Lucentis at both 4 and 12 weeks, meeting the non-inferiority margin at 3 months.
The results also demonstrated a similar reduction in central retinal thickness between ONS-5010 and ranibizumab or Lucentis, suggesting that the treatment is effective in reducing fluid in the retina.
Additionally, ONS-5010 was well-tolerated, with a safety profile consistent with ranibizumab.
Outlook Therapeutics is now on track to resubmit its Biologics License Application or BLA for ONS-5010 in Q1 2025, based on the promising data from this trial.
The company received European Commission Marketing Authorization for the treatment of wet AMD under the brand name LYTENAVA in May 2024 and UK MHRA Marketing Authorization in July 2024.
The commercial launch of LYTENAVA in the EU and UK is expected in the first half of 2025.
This data strengthens the company's outlook as it moves forward with plans for ONS-5010 to become the first approved ophthalmic formulation of bevacizumab for retinal indications.
Currently, OTLK is trading at $2.04 up by 2.39%.
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