Pivotal Phase 3 data from the NORSE TWO registration trial to be presented by Lawrence Lee, MD, MBBS, FRANZCO, FRACS
ISELIN, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Lawrence Lee, MD, MBBS, FRANZCO, FRACS, Associate Professor of Ophthalmology at the University of Queensland and Director of the City Eye Center in Brisbane, Australia, will present pivotal safety and efficacy data from Outlook Therapeutics’ Phase 3 NORSE TWO registration trial evaluating ONS-5010, an investigational ophthalmic formulation of bevacizumab, for use in wet AMD. The presentation will take place virtually at the RANZCO 52nd Annual Scientific Congress on Saturday, February 26, 2022 from 9:45 PM – 10:15 PM ET (Sunday, February 27, 2022 from 13:45 PM – 14:15 PM AEDT).
“The clinical results from the pivotal NORSE TWO trial are exciting,” said Dr. Lee. “As a practicing ophthalmologist, I would welcome the addition of an on-label bevacizumab that is specifically formulated to meet the exacting standards in ophthalmology. If approved by the FDA, ONS-5010 will allow clinicians to treat their retina patients with a product that avoids the risks of off-label, repackaged IV bevacizumab.”
Details for the presentation are as follows:
Safety and efficacy results of ONS-5010, an ophthalmic bevacizumab from the NORSE TWO phase 3 study of monthly intravitreal ONS-5010 in subjects with wet AMD
Presenter: Lawrence Lee, MD, MBBS, FRANZCO, FRACS
Rapid Fire Session: Retina
Date and time: Saturday, February 26, 2022 from 9:45 PM – 10:15 PM ET (Sunday, February 27, 2022 from 13:45 PM – 14:15 PM AEDT)
For more information and to register for this event, please visit RANZCO 2022.
The Royal Australian and New Zealand College of Ophthalmologists (RANZCO) is the medical college responsible for the training, examination and professional development of ophthalmologists in Australia and New Zealand. We seek to improve eye health across Australia and New Zealand, as well as further afield, by providing best quality education, training and continuing professional development; by promoting eye health care and the work of ophthalmologists; and through collaboration with others involved in the delivery of eye health care. For more information, please visit RANZCO.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a BLA under the PHSA 351(a) regulatory pathway. For more information, please visit www.outlooktherapeutics.com.
LaVoie Health Science
Chief Executive Officer
JTC Team, LLC
Source: Outlook Therapeutics, Inc.