• Therapeutic Cataract & Refractive
  • Lens Technology
  • Glasses
  • Ptosis
  • AMD
  • COVID-19
  • DME
  • Ocular Surface Disease
  • Optic Relief
  • Geographic Atrophy
  • Cornea
  • Conjunctivitis
  • Myopia
  • Presbyopia
  • Allergy
  • Nutrition
  • Pediatrics
  • Retina
  • Cataract
  • Contact Lenses
  • Lid and Lash
  • Dry Eye
  • Glaucoma
  • Refractive Surgery
  • Comanagement
  • Blepharitis
  • OCT
  • Patient Care
  • Diabetic Eye Disease
  • Technology

Outlook Therapeutics updates status of Lytenava (bevacizumabvikg) NORSE 1


Patient enrollment for NORSE 2 completed

Outlook Therapeutics remains on track to report topline results in August from NORSE 1, the company’s first registration clinical trial evaluating ONS-5010. Clinical experience and initial safety and efficacy data will be unveiled.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (AMD). If approved by the U.S. Food and Drug Administration (FDA), ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indications including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO), according to the company.

Related: CooperVision reveals virtual exhibit booth

ONS-5010 is a full-length, humanized anti-vascular endothelial growth factor (VEGF) recombinant monoclonal antibody (mAb) that works by blocking the growth of abnormal blood vessels secreted in the eyes of wet AMD patients. The drug is administered as an intravitreal injection, dosed monthly.

“The next key element in our streamlined regulatory pathway for ONS-5010 is our ongoing pivotal clinical trial, NORSE 2, which remains on track to complete enrollment within the next two months, with topline results expected in the third calendar quarter of 2021,” said Lawrence Kenyon, President of Outlook Therapeutics, in a statement.

Related: Study shows cryopreserved amniotic membranes improve SJS and TEN

“Additionally, we are preparing to initiate the NORSE 3 open-label study, which is meant to ensure enough patients have been exposed to ONS-5010 to meet the requirements for our planned BLA submission next year. We expect to commence NORSE 3 in the fourth calendar quarter of 2020.”

If approved, Outlook Therapeutics plans to commercialize ONS-5010 in the United States, Europe, Japan, and other markets. Additionally, the company expects to file ONS-5010 with the FDA as a new biologics license application (BLA) under the Public Health Service Act 351(a) regulatory pathway.

Patient enrollment for the NORSE 2 clinical trial for ONS-5010 has been completed.

Related: Demodox blepharitis treatment shows positive results, says Tarsus

Related Videos
Andy Morgenstern, OD, FAAO, FNAP chats with Optometry Times
R Tracy Williams, OD, FAAO with Optometry Times
Shan Lin, MD, speaks on Glaucoma 360 presentation in an interview with Ophthalmology Times
Cecelia Koetting, OD, FAAO, DIPABO, left, speaks with Optometry Times about the 2024 EnVision Summit
Bonnie An Henderson, MD, highlights key takeaways of the 2024 EnVision Summit, including diversity and family inclusion
Danica Marrelli, OD, FAAO, AAO Dipl, co-chair of EnVision Summit chats about geographic atrophy and glaucoma panels
Robert Weiss, former CEO and President of The Cooper Companies, Inc. (left) and Optometry Times' Assistant Managing Editor Emily Kaiser Maharjan Image Credit ©Optometry Times
© 2024 MJH Life Sciences

All rights reserved.