Outlook Therapeutics to Present Pivotal Data from NORSE TWO Trial at the 9th International Congress on OCT and OCT Angiography in Rome (ICOOR)/ FLORetina Symposia

Rhea-AI Summary

Outlook Therapeutics announced that Francesco Bandello, MD, FEBO, will present pivotal safety and efficacy data from the NORSE TWO trial for ONS-5010 / LYTENAVA at the 9th International Congress on OCT and OCT Angiography in Rome on December 18, 2021. This investigational formulation targets wet age-related macular degeneration (wet AMD). Dr. Bandello emphasized the potential significance of these results for retinal specialists and patients. The presentation is scheduled for 5:48 AM ET.

Francesco Bandello, MD, FEBO, will present Phase 3 pivotal safety and efficacy data from the NORSE TWO registration trial

ISELIN, N.J., Dec. 15, 2021 (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 Francesco Bandello, MD, FEBO, Professor and Chairman of the Department of Ophthalmology, University Vita-Salute, Ospedale San Raffaele, Milan, will present pivotal safety and efficacy data from Outlook Therapeutics’ Phase 3 NORSE TWO registration trial for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration (wet AMD). The presentation will take place at the 9^th International Congress on OCT and OCT Angiography in Rome (ICOOR)/ FLORetina Symposia, on Saturday, December 18, 2021.

“The results observed for ONS-5010 in the NORSE TWO trial are potentially of great significance for retinal specialists and their patients suffering from wet AMD,” said Dr. Bandello. “I look forward to having an additional approved treatment option for patients that is on-label and specifically formulated and packaged to meet the stringent demands for ophthalmic use.”

Details for Dr. Bandello’s presentation are as follows:

Clinical and Efficacy Outcomes of the NORSE TWO Pivotal Study for ONS-5010, an Ophthalmic Formulation of Bevacizumab
Presenter: Francesco Bandello, MD, FEBO
Session: ICOOR 2021 Hall, Visions of Future by Industry and Engineers, Part 2
Date and time: Saturday, December 18, 2021, 5:48 AM – 5:54 AM Eastern Time (11:48 AM– 11:54 AM Central European Time)

For more information and to register for this event, please visit ICOOR 2021.

About ICOOR and FLORetina

The International Congress on OCT and OCT Angiography in Rome (ICOOR) and the FLORetina Symposia are conducted under the auspices of AP Meetings. For almost 15 years, AP Meetings has catered to the scientific and medical communities and to surgical and pharmaceutical companies, organizing meetings with single and multiple sponsors, congresses, conventions, conferences, master courses of international and national importance. AP Meetings provides CME (Continuing Medical Education) and accreditation services for professional residential training and retraining and CPD (online) for healthcare (medical and para-medical). ICOOR/ FLORetina provides an international forum for significant scientific presentations in the field of ophthalmology.

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 significance of the NORSE TWO trial for Outlook Therapeutics (OTLK)?

The NORSE TWO trial presents pivotal safety and efficacy data for ONS-5010, potentially offering a new treatment option for wet AMD patients.

When will Dr. Bandello present the NORSE TWO trial data?

Dr. Bandello's presentation will occur on December 18, 2021, at 5:48 AM Eastern Time.

What is ONS-5010 / LYTENAVA by Outlook Therapeutics (OTLK)?

ONS-5010, also known as LYTENAVA, is an investigational ophthalmic formulation of bevacizumab aimed at treating retinal diseases including wet AMD.

Where can I find more information about the ICOOR 2021 event?

More information about ICOOR 2021 can be found on their official website, where you can also register for the event.

What are the expected commercial plans for ONS-5010 by Outlook Therapeutics (OTLK)?

Outlook Therapeutics aims to commercialize ONS-5010 as the first FDA-approved ophthalmic formulation of bevacizumab for treating retinal diseases in various markets.