Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLK), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics Inc (OTLK) is a clinical-stage biopharmaceutical company advancing innovative ophthalmic therapies, including its lead candidate for wet age-related macular degeneration. This page offers investors and industry professionals timely updates on company developments.
Access comprehensive coverage of OTLK's progress, including regulatory milestones, clinical trial results, strategic partnerships, and financial performance. Our curated news collection ensures you stay informed about critical developments in monoclonal antibody research and ophthalmic treatment advancements.
Key focus areas include updates on European Union and UK regulatory pathways, in-house manufacturing capabilities, and scientific innovations addressing unmet medical needs. All content is verified for accuracy and presented in clear language for expert and general audiences alike.
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Outlook Therapeutics has announced highly significant results from the Phase 3 NORSE TWO trial of ONS-5010, an ophthalmic formulation of bevacizumab, designed for wet age-related macular degeneration (wet AMD). The trial demonstrated that 41.7% of patients gained at least 15 letters in vision and met both primary and secondary endpoints. The company plans to submit a BLA to the U.S. FDA in Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab, which could provide significant benefits for AMD patients.
Outlook Therapeutics (Nasdaq: OTLK) will host a Virtual Investor Roundtable Event on November 16, 2021, at 9:00 AM ET. Management, including President C. Russell Trenary and COO Terry Dagnon, will discuss the development of ONS-5010 (LYTENAVA™), the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. Key thought leaders, Firas M. Rahhal, MD, and Robert L. Avery, MD, will join the discussion. A live video webcast will be accessible on their website and a replay will be available for one year.
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.
Outlook Therapeutics presents at Eyecelerator@AAO 2021 Conference
ISELIN, N.J., Nov. 3, 2021 - Outlook Therapeutics (Nasdaq: OTLK) announced that CEO C. Russell Trenary will present at the Eyecelerator@AAO 2021 Retina Showcases in New Orleans on November 11, 2021, from 1:10 PM to 1:15 PM EST. The company focuses on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases such as wet AMD and DME. If approved, it could be the only FDA-approved ophthalmic formulation of this drug in various global markets.
Outlook Therapeutics presented strong safety data from the NORSE THREE study of ONS-5010 at the 39th Annual Meeting of the American Society of Retina Specialists. The trial demonstrated no unexpected safety trends, with adverse events primarily related to injection procedures. ONS-5010 is being developed as the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The company plans to submit a BLA in early 2022, which, if approved, could lead to 12 years of marketing exclusivity for ONS-5010. This formulation aims to replace off-label alternatives currently in use.
Suber Huang, MD, MBA, FASRS will present safety data from Outlook Therapeutics’ NORSE THREE registration trial on October 12, 2021. The study focuses on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational formulation for retinal indications. The presentation will occur at the 2021 Annual Meeting of the American Society of Retina Specialists in San Antonio, Texas, highlighting safety results in patients with wet AMD, DME, and BRVO. If approved, ONS-5010 is expected to be the first FDA-approved ophthalmic formulation of bevacizumab.
Outlook Therapeutics will showcase its innovations at the OIS Retina Innovation Showcase on October 7, 2021. C. Russell Trenary, President and CEO, will present the company's mission to introduce the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions. The presentation is set for 8:55 AM CT, followed by a panel with Jeff Evanson, Chief Commercial Officer, at 4:35 PM CT. Their product, ONS-5010/LYTENAVA™, aims to treat wet AMD, DME, and BRVO, targeting U.S. and international markets.
Outlook Therapeutics announced new 12-month safety data from the pivotal Phase 3 NORSE TWO trial for its investigational ophthalmic formulation ONS-5010 (bevacizumab-vikg) targeting wet age-related macular degeneration (AMD). The results confirm a strong safety profile consistent with previous trials. Topline findings reveal 41% of patients treated with ONS-5010 gained at least 15 letters in visual acuity compared to 23% with ranibizumab. Plans for a Biologics License Application submission to the FDA are set for Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab.
Outlook Therapeutics fireside chat details
On September 28, 2021, at 2:00 PM ET, C. Russell Trenary, President and CEO of Outlook Therapeutics (Nasdaq: OTLK), will participate in a live fireside chat during the Cantor Fitzgerald Virtual Global Healthcare Conference. This event includes opportunities for virtual one-on-one meetings with the investor community. The chat will be accessible via a live webcast on the company's Investors page and available for 90 days post-event.
Outlook Therapeutics aims to develop ONS-5010 as the first FDA-approved ophthalmic formulation of bevacizumab.
Outlook Therapeutics (Nasdaq: OTLK) announced the presentation of safety data from the NORSE THREE trial for ONS-5010 (LYTENAVA™), an ophthalmic formulation of bevacizumab, at the EURETINA Virtual 2021 conference. The study, involving 197 subjects with retinal diseases like wet AMD, showed no unexpected safety trends. It aims to support a biologics license application (BLA) submission in early 2022, potentially granting ONS-5010 12 years of market exclusivity if approved. The company also reported positive results from the NORSE TWO trial, indicating significant efficacy.
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