Outlook Therapeutics to Present at the Retina Subspecialty Day, American Academy of Ophthalmology 2021 Annual Conference

Rhea-AI Summary

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that Dr. Firas M. Rahhal will present pivotal Phase 3 data from the NORSE TWO trial on November 13, 2021. This presentation will cover the safety and efficacy of ONS-5010 / LYTENAVA™, an investigational ophthalmic formulation of bevacizumab for retinal conditions. The event takes place during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) 2021 Annual Conference in New Orleans. If approved, ONS-5010 is expected to be the first FDA-approved ophthalmic formulation of bevacizumab, targeting wet AMD and other retinal diseases.

Firas M. Rahhal, MD, will present Phase 3 pivotal data from the NORSE TWO registration trial on Saturday, November 13, 2021

ISELIN, N.J., Nov. 04, 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 Firas M. Rahhal, MD, Retina-Vitreous Associates Medical Group, Assoc. Clinical Professor of Ophthalmology, UCLA School of Medicine, will present safety and efficacy data from Outlook Therapeutics’ Phase 3 pivotal NORSE TWO trial for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in retinal indications. Dr. Rahhal will present the data in an oral presentation at the Retina Subspecialty Day of the American Academy of Ophthalmology (AAO) 2021 Annual Conference being held in New Orleans, Louisiana.

Details for the presentation are as follows:

Safety and Efficacy Results of ONS-5010, an Ophthalmic Bevacizumab, Phase 3 Pivotal Study of Monthly Intravitreal ONS-5010 in Subjects with Wet AMD (NORSE TWO)
Presenter: Firas M. Rahhal, MD
Session: Section X: Late Breaking Developments, Part II
Date and time: Saturday, November 13, 2021, at 9:17 AM EDT

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

About American Academy of Ophthalmology

Launched in 1979, the American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the AAO serves to protect sight and empower lives by setting the standards for ophthalmic education and advocating for patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care.

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 are the details of Dr. Firas M. Rahhal's presentation at the AAO 2021 Annual Conference?

Dr. Firas M. Rahhal will present safety and efficacy results of ONS-5010, an ophthalmic formulation of bevacizumab, at 9:17 AM EDT on November 13, 2021.

What is the significance of the NORSE TWO trial data for Outlook Therapeutics?

The NORSE TWO trial data is crucial as it supports the safety and efficacy of ONS-5010, which aims to be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications.

When is the AAO 2021 Annual Conference taking place?

The AAO 2021 Annual Conference will be held from November 12 to 15, 2021, in New Orleans, Louisiana.

What is ONS-5010 and its potential market impact?

ONS-5010, if approved, could become the first FDA-approved ophthalmic formulation of bevacizumab for treating retinal diseases like wet AMD, DME, and BRVO in several global markets.

How does Outlook Therapeutics plan to commercialize ONS-5010?

Outlook Therapeutics plans to submit ONS-5010 for FDA approval under the BLA pathway, aiming to commercialize it once approved for use in multiple regions, including the U.S.