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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 (Nasdaq: OTLK) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for ONS-5010, their ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The FDA designated it as a Class 2 review with a PDUFA goal date of August 27, 2025.
If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity. The resubmission includes efficacy and safety data from the NORSE EIGHT trial, along with additional chemistry, manufacturing, and controls information requested by the FDA.
The company has already secured regulatory approval for this treatment in the European Union and United Kingdom, marking it as the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions.
Outlook Therapeutics (OTLK) has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, branded as LYTENAVA™ (bevacizumab-vikg), for treating wet age-related macular degeneration (wet AMD). The resubmission follows the company's recent regulatory approvals in the EU and UK.
The BLA includes data from the NORSE EIGHT trial, a randomized study of 400 wet AMD patients comparing ONS-5010 to ranibizumab. While ONS-5010 showed clinical improvements with 3.3 to 5.5 letter improvement in vision across timepoints, it did not meet the pre-specified non-inferiority endpoint at week 8. However, anatomical response was comparable between treatments, with ONS-5010 achieving a -123.9 micron reduction in central retinal thickness versus -127.3 microns for ranibizumab.
An FDA decision is expected within six months.
Outlook Therapeutics (OTLK) announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. The company's CFO and Interim CEO, Lawrence A. Kenyon, presented the top five reasons why investors should focus on Outlook Therapeutics in 2025. The presentation is now available for viewing online.
Notably, OTLK is a biopharmaceutical company that has achieved regulatory approval in the European Union and the United Kingdom for its ophthalmic formulation of bevacizumab, marking the first authorized use of such treatment for wet age-related macular degeneration (wet AMD).
Outlook Therapeutics (OTLK) reported financial results for Q1 FY2025 and provided key updates. The company plans to resubmit its ONS-5010 BLA in Q1 2025, with potential FDA approval expected in Q3 2025. Commercial launches of LYTENAVA™ (bevacizumab gamma) are planned for Germany and UK in Q2 2025, marking the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment in these regions.
For Q1 FY2025, OTLK reported net income of $17.4 million ($0.72 per share), compared to a net loss of $11.2 million ($0.86 per share) in the same period last year. The company had cash and cash equivalents of $5.7 million as of December 31, 2024, with additional $17.8 million received in January 2025 from warrant exercises.
In the NORSE EIGHT trial, while ONS-5010 missed the primary endpoint at week 8, it met non-inferiority margins at week 12, showing mean visual acuity improvements and similar anatomical response compared to ranibizumab.
Outlook Therapeutics (OTLK) announced that Dr. Jennifer Kissner, SVP Clinical Development, participated in a Virtual Investor segment to discuss the NORSE EIGHT clinical trial results. The segment focuses on the complete 12-week safety and efficacy data for ONS-5010, their ophthalmic bevacizumab formulation for wet AMD treatment.
The company, which has already secured regulatory approval in the European Union and United Kingdom for the first authorized ophthalmic bevacizumab formulation to treat wet age-related macular degeneration, plans to resubmit its Biologics License Application (BLA) in Q1 2025. NORSE EIGHT represents the second of two adequate and well-controlled clinical trials evaluating ONS-5010 in wet AMD patients.
Outlook Therapeutics (OTLK) has appointed Faisal G. Sukhtian as Chairman of the Board of Directors, replacing Randy Thurman who will continue as Lead Independent Director. The change comes at a important time as the company prepares to launch LYTENAVA™, their ophthalmic formulation of bevacizumab for wet AMD treatment, which has received regulatory approval in the EU and UK.
Sukhtian, who has served on OTLK's board since 2017, brings extensive experience in operations, strategy development, and M&A in the biopharma sector. He currently serves as Executive Director at GMS Holdings and holds board positions at several companies including Genepharm and MS Pharma. The company is focusing on completing FDA resubmission in the United States while preparing for the European launch of LYTENAVA™.
Outlook Therapeutics (OTLK) presented data from its NORSE EIGHT clinical trial evaluating ONS-5010 for wet AMD treatment at the Hawaiian Eye and Retina 2025 Meeting. The trial compared ONS-5010 with ranibizumab in newly diagnosed wet AMD patients.
Key results showed ONS-5010 achieved mean BCVA improvements of +3.3, +4.2, and +5.5 letters at Months 1, 2, and 3 respectively. The treatment demonstrated non-inferiority to Lucentis at 4 and 12 weeks, though it didn't meet the pre-specified non-inferiority endpoint at week 8. Anatomical response showed similar results between treatments, with central retinal thickness reduction of -123.9 microns for ONS-5010 versus -127.3 microns for ranibizumab.
The company plans to resubmit its BLA in Q1 2025. ONS-5010 has already received Marketing Authorization in the EU and UK, with European launch planned for first half of 2025.
Outlook Therapeutics (OTLK) has announced its participation in the upcoming LIVE! with Webull Corporate Connect: Healthcare Investment Webinar on January 29, 2025, at 2:00 PM ET. Lawrence A. Kenyon, the company's Executive Vice President, CFO and Interim CEO, will be presenting at the virtual event.
The announcement comes following the company's significant achievement of obtaining regulatory approval in the European Union (EU) and the United Kingdom (UK) earlier this year for their groundbreaking ophthalmic formulation of bevacizumab. This marks the first authorized use of such a formulation for treating wet age-related macular degeneration (wet AMD).
Outlook Therapeutics (OTLK) has announced complete 12-week efficacy and safety results for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. The trial demonstrated non-inferiority to ranibizumab at week 12, with ONS-5010 showing a mean 5.5 letter improvement in BCVA compared to 6.5 letters for ranibizumab.
The company plans to resubmit its Biologics License Application (BLA) in Q1 2025. While the trial didn't meet its week 8 primary endpoint, the 12-week data showed consistent improvement and comparable safety to ranibizumab. ONS-5010 has already received marketing authorization in the EU and UK, with European launch planned for first half of 2025.
Additionally, OTLK has entered into warrant inducement transactions expected to generate up to $20.4 million in gross proceeds, which will fund clinical development programs, European commercial launch, and working capital.
Outlook Therapeutics (OTLK) announced that Jedd Comiskey, Senior Vice President and Head of Europe, participated in a Virtual Investor segment discussing the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for treating wet age-related macular degeneration (wet AMD).
LYTENAVA™ is significant as it represents the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in adults in both the EU and UK. The company has secured regulatory approvals in these regions earlier this year, with an initial 10-year market exclusivity period.
