Outlook Therapeutics finishes patient registration for NORSE 1 trial
Category: #health  By Paroma Bhattacharya  Date: 2019-08-22
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Outlook Therapeutics finishes patient registration for NORSE 1 trial
  • NORSE 1 has registered a sum of 61 patients from nine different sites in Australia.
     
  • This study is first of the two current, well controlled and adequate Phase 3 clinical trials examining ONS-5010 for wet AMD.

Outlook Therapeutics Inc., a clinical stage biopharmaceutical organization aimed at commercializing and developing ONS-5010, a commercially attractive antibody and ophthalmic bevacizumab product to treat wet age-related macular degeneration (wet AMD) as well as few other retina diseases, reportedly announced the completion of enrollment of patients for NORSE 1 Phase 3 clinical trial, a study that is examining ONS- 5010 for wet AMD against ranibizumab (Lucentis®).

NORSE 1 has registered approximately 61 patients from nine different sites in Australia. This study is first of the two current, well controlled and adequate Phase 3 clinical trials examining ONS-5010 against ranibizumab (Lucentis®) for wet AMD.

The final point of the study is average change in the baseline of visual acuity at approximately 11 months for ONS-5010 administered once in a month compared to ranibizumab (Lucentis®) dosed utilizing the PIER alternate medicating regimen of three doses in a month which will be followed by quarterly doses. The company is expecting to unveil the topline output of NORSE 1 by the third quarter of next year.

Chief Financial Officer, Chief Executive Officer and President of Outlook Therapeutics, Lawrence A. Kenyon stated that company is pleased with increasing momentum in its two current Phase 3 clinical trials of ONS-5010, which includes enrollment completion in NORSE 1.

Kenyon added that reaching this milestone keeps the company on track to achieve its aim of submitting ONS-5010 in the United States for regulatory approval next year.

The success of ONS-5010 would help Outlook’s aim of submitting it for regulatory approval across multiple markets next year. If permitted, ONS-5010 is capable to mitigate risks connected with off-label consumption of Avastin and some other drugs.

Avastin drug’s off-label use is estimated to be 50% in the United States among all the wet AMD prescriptions.



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Paroma Bhattacharya

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Paroma Bhattacharya

Paroma currently works as a content developer for Algosonline, MSF and a series of alike platforms. Fortified with a post-graduation degree in Journalism and Mass Communication, she delved head long into a writing career, creating resourceful and information enriched ...

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