Outlook Therapeutics to Present at the 14th Asia-Pacific Vitreo-Retina Society (APVRS) Congress

Rhea-AI Summary

Outlook Therapeutics announced that Dr. Suber Huang will present pivotal data from the Phase 3 NORSE TWO trial for ONS-5010 (bevacizumab-vikg) targeting wet AMD at the 14th Asia-Pacific Vitreo-Retina Society Congress on December 10, 2021. The results are significant, positioning ONS-5010 as a potential FDA-approved ophthalmic formulation, which could mitigate adverse effects linked to off-label use of repackaged IV bevacizumab. If approved, this formulation will be the first on-label treatment for retinal diseases, supporting Outlook’s endeavor to enhance patient care.

Suber Huang, MD, MBA, FASRS will present data from the Phase 3 pivotal NORSE TWO registration trial

ISELIN, N.J., Dec. 09, 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 Suber Huang, MD, MBA, FASRS, Founder and CEO of the Retina Center of Ohio, will present safety and efficacy data from Outlook Therapeutics’ Phase 3 pivotal NORSE TWO trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab, for use in wet AMD. The presentation will take place virtually at the 14^th Asia-Pacific Vitreo-Retina Society (APVRS) Congress on December 10, 2021 at 11:20 – 11:30 PM ET (December 11, 2021 at 12:20 – 12:30 PM HKT).

“It is exciting to see the success of the NORSE TWO trial,” said Dr. Huang. “The clinical results from NORSE TWO were highly significant and move Outlook Therapeutics one step closer towards providing patients and retina specialists with the first on-label ophthalmic bevacizumab. If approved, ONS-5010 will avoid the potentially serious adverse events associated with off-label repackaged IV bevacizumab from compounding pharmacies.”

Details for the special plenary session presentation are as follows:

Safety and Efficacy Results of ONS-5010 – An Ophthalmic Bevacizumab from a Phase 3 Study of Monthly Intravitreal ONS-5010 in Subjects with Wet AMD (NORSE TWO)
Presenter: Suber S. Huang, MD, MBA, FASRS
Session: Plenary Session, 0087
Date and time: Friday, December 10, 2021, 11:20 – 11:30 PM ET (Saturday, December 11, 2021, 12:20 – 12:30 PM HKT)

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

About Asia-Pacific Vitreo-Retina Society

The Asia-Pacific Vitreo-Retina Society (APVRS) is the premier retina subspecialty organization and one of six subspecialty organizations and 29 member organizations that comprise the Asia Pacific Academy of Ophthalmology. Serving a regional population of 4.5 billion individuals, the goals of the APVRS are to develop the vitreoretinal subspecialty in the Asia-Pacific region, to share vitreoretinal skills and knowledge with ophthalmologists, and to promote and disseminate knowledge of vitreoretinal diseases, eye care and eye health issues to the general public.

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 data presented by Outlook Therapeutics?

The NORSE TWO trial data, presented by Dr. Suber Huang, showcases the safety and efficacy of ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet AMD.

When will the presentation on ONS-5010 take place?

The ONS-5010 presentation will occur on December 10, 2021, from 11:20 – 11:30 PM ET at the APVRS Congress.

What is ONS-5010 and why is it significant?

ONS-5010 is an investigational ophthalmic formulation of bevacizumab that aims to be the first FDA-approved on-label treatment for retinal diseases.

How does ONS-5010 compare to off-label formulations?

ONS-5010 aims to avoid serious adverse events associated with off-label repackaged IV bevacizumab, offering a safer alternative.

What are the expected markets for ONS-5010 if approved?

If approved, ONS-5010 is expected to be marketed in the United States, United Kingdom, Europe, and Japan.

What is the purpose of the Asia-Pacific Vitreo-Retina Society Congress?

The APVRS Congress aims to develop the vitreoretinal subspecialty, sharing knowledge and skills among ophthalmologists.