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Outlook Therapeutics to Present Pivotal Data from NORSE TWO Trial


GlobeNewswire Inc | Dec 15, 2021 08:05AM EST

December 15, 2021

ISELIN, N.J., Dec. 15, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical companyworking to develop and launch the first FDA-approved ophthalmic formulation of bevacizumabfor use in retinalindications, 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 9th 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. Bandellos presentation are as follows:

Clinical and Efficacy Outcomes of the NORSE TWO Pivotal Study for ONS-5010, an Ophthalmic Formulation of BevacizumabPresenter: Francesco Bandello, MD, FEBOSession: ICOOR 2021 Hall, Visions of Future by Industry and Engineers, Part 2Date 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 UllmanVice PresidentLaVoie Health ScienceT: 617-669-3082hullman@lavoiehealthscience.com

Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 833.475.8247OTLK@jtcir.com







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