This section highlights FDA-related milestones and regulatory updates for drugs developed by Oncobiologics (OTLK).
Over the past two years, Oncobiologics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYTENAVA and ONS-5010. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LYTENAVA - FDA Regulatory Timeline and Events
LYTENAVA is a drug developed by Oncobiologics for the following indication: For the Treatment of Wet AMD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYTENAVA
- Announced Date:
- June 10, 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Outlook Therapeutics, Inc announced the Scottish Medicines Consortium (SMC) acceptance of LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
Outlook Therapeutics, Inc. announced that the Scottish Medicines Consortium (SMC) has accepted LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for treating wet age-related macular degeneration (wet AMD). This approval marks a major milestone as LYTENAVA™ is the first and only licensed ophthalmic formulation of bevacizumab for wet AMD in adults in the United Kingdom. The decision by the SMC means that Scottish patients will now have access to this important treatment option, potentially improving outcomes for those affected by the vision-threatening condition.
The approval also grants an initial 10-year market exclusivity period from the date of the Medicines and Healthcare products Regulatory Agency’s (MHRA) marketing authorization. Outlook Therapeutics is focused on working closely with healthcare providers to ensure a smooth rollout and is dedicated to advancing healthcare solutions for retina diseases.
Read Announcement- Drug:
- LYTENAVA
- Announced Date:
- June 2, 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Outlook Therapeutics, Inc. announced that LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
Outlook Therapeutics, Inc. has announced that its ophthalmic formulation, LYTENAVA™ (bevacizumab gamma), is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD). This launch marks a significant milestone as LYTENAVA™ is the first and only approved version of bevacizumab specifically formulated for ophthalmic use in these regions. The new product targets wet AMD by reducing retinal blood vessel leakage and inhibiting abnormal vessel growth, providing a safer option compared to the off-label use of repackaged bevacizumab. Outlook Therapeutics is optimistic about the drug’s success and plans to extend its availability further throughout the European market in the near future.
Read Announcement- Drug:
- LYTENAVA
- Announced Date:
- December 4, 2024
- Indication:
- For the Treatment of Wet AMD
Announcement
LYTENAVA announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma), as an option for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity.
AI Summary
LYTENAVA™ (bevacizumab gamma) has received a positive reimbursement decision from the UK's National Institute for Health and Care Excellence (NICE) for treating wet age-related macular degeneration (wet AMD). This recommendation marks the first positive reimbursement decision worldwide for LYTENAVA™, now recognized as a cost-effective treatment option for patients suffering from wet AMD in England and Wales. It is the only approved ophthalmic formulation of bevacizumab, offering a targeted treatment approach for the estimated 40,000 UK patients diagnosed with wet AMD annually.
The treatment is set for a commercial launch in the United Kingdom in the first half of 2025, backed by an initial market exclusivity period of 10 years. The decision by NICE builds momentum for Outlook Therapeutics' broader commercialization strategy, with plans to expand the treatment across other EU countries as pricing and reimbursement processes progress.
Read Announcement- Drug:
- LYTENAVA
- Announced Date:
- December 4, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Outlook Therapeutics, Inc announced that First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025.
AI Summary
Outlook Therapeutics, Inc. has announced a major milestone with LYTENAVA™ receiving the first positive reimbursement decision worldwide. This decision, made by the UK’s National Institute for Health and Care Excellence (NICE), supports the use of LYTENAVA™ as a treatment for wet age-related macular degeneration (wet AMD). The recommendation by NICE marks a key step in ensuring that patients in England and Wales have access to this cost-effective treatment option.
LYTENAVA™ is notable as the first and only approved ophthalmic formulation of the drug bevacizumab for wet AMD in the European Union and the United Kingdom. Outlook Therapeutics plans to launch the product in the UK in the first half of 2025, with further efforts underway to secure pricing and reimbursement approvals in other EU countries. This move is expected to benefit thousands of new wet AMD patients each year by offering a licensed, high-quality treatment option.
Read Announcement- Drug:
- LYTENAVA
- Announced Date:
- July 8, 2024
- Indication:
- For the Treatment of Wet AMD
Announcement
Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK.
AI Summary
Outlook Therapeutics, Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation approved for the treatment of wet age-related macular degeneration (wet AMD). This milestone marks the first authorized ophthalmic bevacizumab treatment for wet AMD in the UK and EU. The decision follows positive clinical trials that met key endpoints, offering a secure alternative to off-label bevacizumab use. The authorization ensures controlled manufacturing standards, reducing concerns associated with compounding pharmacies. Outlook Therapeutics plans to commercially launch LYTENAVA™ in both the UK and EU in the first quarter of 2025, in strategic partnership with Cencora, which will support market access and distribution. The approval is a significant step for healthcare providers and patients, promising enhanced safety and efficacy for wet AMD treatment in these regions.
Read Announcement- Drug:
- LYTENAVA
- Announced Date:
- May 28, 2024
- Indication:
- For the Treatment of Wet AMD
Announcement
Outlook Therapeutics, Inc announced that the European Commission has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU.
AI Summary
Outlook Therapeutics, Inc. announced that the European Commission has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), marking it as the first and only approved ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) in the EU. This decision automatically applies to all 27 EU Member States and, within 30 days, to Iceland, Norway, and Liechtenstein. The approval is based on a robust clinical program that included three complete registration studies. Additionally, LYTENAVA™ receives a ten-year market exclusivity, supporting Outlook’s strategy to commercialize the product, with an anticipated EU launch in the first calendar quarter of 2025. Outlook is working closely with its strategic partner Cencora to ensure a smooth and efficient market entry, aiming to offer a meaningful new treatment option for patients facing wet AMD across Europe.
Read Announcement
ONS-5010 / LYTENAVA (Bevacizumab-vikg) - FDA Regulatory Timeline and Events
ONS-5010 / LYTENAVA (Bevacizumab-vikg) is a drug developed by Oncobiologics for the following indication: Wet age-related macular degeneration (wet AMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- April 8, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD.
AI Summary
Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of its resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg). This investigational ophthalmic formulation is designed for treating wet age-related macular degeneration (wet AMD) in the United States. The application has been designated as a Class 2 review by the FDA, which sets a six‐month review period starting from the resubmission date.
The FDA has also established a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, for the potential approval of ONS-5010. If approved, the product will be marketed in the United States as LYTENAVA™, and it is expected to gain 12 years of regulatory exclusivity. Outlook Therapeutics highlighted that the submission includes additional data from the NORSE EIGHT study and updated information on chemistry, manufacturing, and controls, reinforcing its evidence for potential approval.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- April 8, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc announced that he FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025.
AI Summary
Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, for its resubmitted Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet age-related macular degeneration (wet AMD). The FDA has designated the review as a Class 2, meaning the application will receive a six-month review period starting from the resubmission date.
If approved, ONS-5010 will be marketed in the United States as LYTENAVA™ (bevacizumab-vikg) and is expected to enjoy 12 years of regulatory exclusivity. Outlook Therapeutics highlighted this milestone as a significant step forward in providing the first on-label ophthalmic bevacizumab for the treatment of wet AMD to clinicians and patients in the U.S.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- February 28, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
Outlook Therapeutics, Inc. has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational product ONS-5010. If approved, the ophthalmic formulation will be marketed as LYTENAVA™ (bevacizumab-vikg), aimed at treating wet age-related macular degeneration (wet AMD). The resubmission includes updated data on safety and effectiveness, drawing on findings from the NORSE EIGHT clinical study along with additional chemistry, manufacturing, and controls information. The company believes this new submission provides the strong evidence needed to support approval by the FDA. Outlook Therapeutics emphasizes its commitment to bringing a specifically formulated ophthalmic bevacizumab to the U.S. market, offering a potential treatment option for retina patients who currently face challenges with unapproved repackaged therapies for wet AMD.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- February 4, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced that Jennifer Kissner, Ph.D., SVP Clinical Development of Outlook Therapeutics participated in a Virtual Investor "What This Means" segment.
AI Summary
Outlook Therapeutics, Inc. announced a Virtual Investor “What This Means” segment featuring Dr. Jennifer Kissner, Ph.D., SVP Clinical Development. During the session, Dr. Kissner discussed the complete 12‑week safety and efficacy results from the NORSE EIGHT clinical trial, which is evaluating ONS‑5010 in patients with wet age‑related macular degeneration (wet AMD). She explained how these positive trial findings support the company’s next steps, which include a planned resubmission of a Biologics License Application in the first quarter of 2025.
The presentation provided investors with key insights into Outlook Therapeutics’ strategy for advancing ONS‑5010 as a treatment option for wet AMD. Dr. Kissner’s remarks emphasized the company’s commitment to ensuring both safety and effectiveness in its clinical studies, reinforcing its goal to deliver improved treatment solutions for retinal diseases.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- January 23, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting being held January 18-24, 2025 in Kauai, HI..
AI Summary
Outlook Therapeutics, Inc. presented key data from its NORSE EIGHT trial at the Hawaiian Eye and Retina 2025 Meeting in Kauai, HI. The data, presented by Dr. Baruch D. Kuppermann of the Gavin Herbert Eye Institute, focused on evaluating the safety and effectiveness of the drug ONS-5010 for patients with wet age-related macular degeneration. The trial compared ONS-5010 to ranibizumab and showed that patients receiving ONS-5010 experienced early, consistent improvements in visual acuity and retinal anatomy over the 12-week period. The trial met its non-inferiority margin compared to ranibizumab, strengthening the case for ONS-5010 as a reliable treatment option. The results add to ongoing evidence supporting the potential benefits of this new formulation, and Outlook Therapeutics remains on track to resubmit their Biologics License Application to the FDA in the first quarter of 2025.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- January 16, 2025
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced that BLA resubmission on track for calendar Q1 2025
AI Summary
Outlook Therapeutics announced that it is preparing to resubmit its Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025. This decision follows the completion of the NORSE EIGHT trial’s 12‐week analysis, where ONS-5010 demonstrated non-inferiority to ranibizumab in treating wet age-related macular degeneration (AMD). The trial showed that patients experienced steady improvements in vision along with consistent safety results. Outlook Therapeutics is confident that the positive 12-week results will support the planned resubmission in the United States, potentially paving the way for the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The company continues its preparation work and remains focused on advancing treatment options for patients with wet AMD.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- January 16, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients.
AI Summary
Outlook Therapeutics recently announced that it has completed a full analysis of the 12-week safety and efficacy results from its NORSE EIGHT clinical trial. This trial, one of two well-controlled studies, evaluated ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD). The results showed that ONS-5010 was non-inferior to ranibizumab at week 12, meeting the predefined non-inferiority margin. Patients in the ONS-5010 arm experienced steady gains in visual acuity, while improvements in retinal thickness were similar between both treatment groups.
These positive findings support the safe and effective use of ONS-5010 in wet AMD therapy. Based on the complete 12-week analysis, Outlook Therapeutics plans to resubmit its Biologics License Application in the first quarter of 2025, offering hope for a new treatment option for patients with wet AMD.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- November 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - January 31, 2025
- Target Action Date:
- January 01, 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced that Final efficacy data expected in January 2025
AI Summary
Outlook Therapeutics, Inc. announced that final efficacy data from its NORSE EIGHT trial for its ophthalmic bevacizumab formulation in treating wet age-related macular degeneration will be available in January 2025. This data will include month 3 results, which are critical for the company as it plans to resubmit its Biologics License Application (BLA) in the first quarter of 2025.
The preliminary results showed improvements in vision and maintained a favorable safety profile, despite not meeting the pre-specified non-inferiority endpoint at week 8. Once the complete efficacy and safety data are analyzed, the resubmission is expected to support further regulatory progress and potential approval in the United States.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- November 27, 2024
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced preliminary topline results of NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients.
AI Summary
Outlook Therapeutics, Inc. announced preliminary topline results from the NORSE EIGHT trial, the second of two well-controlled studies evaluating ONS-5010 in patients with wet age-related macular degeneration (wet AMD). In this study, although ONS-5010 did not meet the planned non-inferiority endpoint compared to ranibizumab at week 8, the results showed an improvement in vision and evidence of biological activity. The trial confirmed that the safety profile of ONS-5010 was consistent and comparable to the current treatment. Data from the month 3 assessments are still being collected and analyzed, with final efficacy results expected in January 2025. Based on these findings, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in early Q1 2025, reflecting their continued efforts to advance treatment options for wet AMD.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- November 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc.
AI Summary
Outlook Therapeutics, Inc. today shared early results from its NORSE EIGHT trial, which is evaluating ONS-5010 (also known as LYTENAVA™) for treating wet age-related macular degeneration (wet AMD). While the trial did not fully meet its non-inferiority goal at week 8 compared to ranibizumab, the preliminary results showed some promise with improvements in vision and a favorable safety profile. The company is now collecting additional data from the three‐month mark, expected in January 2025, to better understand the drug’s overall efficacy and safety.
Based on this final analysis, Outlook Therapeutics plans to resubmit its Biologics License Application (BLA) in the first quarter of 2025 in the United States. Meanwhile, LYTENAVA™, which already holds regulatory approval in the European Union and the United Kingdom, is on track for a potential launch in these regions later in 2025.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- September 4, 2024
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients.
AI Summary
Outlook Therapeutics recently announced the successful completion of enrollment for its NORSE EIGHT clinical trial, an important step in evaluating ONS-5010 for patients with wet age-related macular degeneration (wet AMD). This study is a randomized, controlled, and masked non-inferiority trial that will compare the safety and effectiveness of 1.25 mg ONS-5010 with 0.5 mg ranibizumab. Patients in the study will receive intravitreal injections on day 0, week 4, and week 8, with the primary goal of assessing the change in best corrected visual acuity from baseline to week 8.
The company expects to report topline results from NORSE EIGHT in the fourth quarter of 2024. With this milestone achieved, Outlook Therapeutics is one step closer to completing the clinical requirements needed for the resubmission of its Biologics License Application for ONS-5010.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- September 4, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc announced that Topline results from NORSE EIGHT expected in Q4 CY2024
AI Summary
Outlook Therapeutics, Inc. announced that topline results from its NORSE EIGHT clinical trial are expected in Q4 CY2024. The NORSE EIGHT study is a randomized, controlled, and masked non-inferiority trial that compares ONS-5010 to ranibizumab in patients with wet age-related macular degeneration. In this trial, newly diagnosed patients receive intravitreal injections at Day 0, Week 4, and Week 8, with the primary endpoint being the change in best corrected visual acuity (BCVA) from baseline to Week 8.
The trial, conducted under a Special Protocol Assessment with the FDA, is the final anticipated study before the planned resubmission of Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010 in Q1 CY2025. The company expressed gratitude to the patients and clinical teams who helped achieve full enrollment in less than eight months.
Read Announcement- Drug:
- ONS-5010 / LYTENAVA (Bevacizumab-vikg)
- Announced Date:
- May 13, 2024
- Indication:
- Wet age-related macular degeneration (wet AMD)
Announcement
Outlook Therapeutics, Inc. announced the submission of its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) seeking authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
Outlook Therapeutics, Inc. has taken an important step by submitting its Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. The application seeks approval for ONS-5010/LYTENAVA™ (bevacizumab gamma) as a treatment for wet age-related macular degeneration (wet AMD), a condition that can lead to significant vision loss. If authorized, this treatment could provide a new option for patients who suffer from this serious eye disease by helping to slow its progression and preserve vision.
This submission marks a key milestone for Outlook Therapeutics as it shows the company’s commitment to advancing innovative therapies. The MHRA review will focus on ensuring the safety and effectiveness of ONS-5010/LYTENAVA™, and successful approval could pave the way for its use in the United Kingdom, ultimately benefiting patients who need improved treatment options for wet AMD.
Read Announcement
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