Outlook Therapeutics to Present at the RANZCO 52nd Annual Scientific Congress

Rhea-AI Summary

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that Dr. Lawrence Lee will present pivotal Phase 3 data from the NORSE TWO trial on February 26, 2022, regarding ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet AMD. The trial results indicated promising safety and efficacy, and if approved by the FDA, ONS-5010 could mitigate risks associated with off-label use of existing formulations. The presentation will take place at the RANZCO 52nd Annual Scientific Congress.

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 52^nd 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.

About RANZCO

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.

CONTACTS:
Media Inquiries:
Harriet Ullman
Vice President
LaVoie Health Science
T: 617-669-3082
hullman@lavoiehealthscience.com

Investor Inquiries:       
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247 
OTLK@jtcir.com

FAQ

What is the NORSE TWO trial presented by Outlook Therapeutics?

The NORSE TWO trial is a Phase 3 study evaluating the safety and efficacy of ONS-5010, an investigational ophthalmic formulation of bevacizumab, specifically for wet AMD.

When will the NORSE TWO trial data be presented?

The pivotal data from the NORSE TWO trial will be presented on February 26, 2022, from 9:45 PM to 10:15 PM ET.

Who is presenting the NORSE TWO trial results?

Dr. Lawrence Lee, an Associate Professor of Ophthalmology at the University of Queensland, will present the results.

What is ONS-5010 and its significance?

ONS-5010 is an investigational formulation of bevacizumab intended to provide a safer, FDA-approved option for clinicians treating retinal diseases like wet AMD.

Where can I find more information about the RANZCO event?

More information about the RANZCO 52nd Annual Scientific Congress can be found on their official website.