Lytenava (bevacizumab-vikg) / Outlook Therap, Cencora, Ligand - LARVOL DELTA

Outlook Therapeutics Announces Commercial Launch of LYTENAVA (bevacizumab gamma) in Germany and the UK for the Treatment of Wet AMD (GlobeNewswire) - "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). LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK."

Launch Europe • Wet Age-related Macular Degeneration

Efficacy of combined therapy with gamma knife radiosurgery and bevacizumab on survival outcomes in patients with recurrent high-grade glioma: a systematic review and meta-analysis. (PubMed, Neurosurg Rev) - "High heterogeneity was noted for overall survival (I² = 98.24%), warranting cautious interpretation. This meta-analysis suggests that while Gamma Knife combined with bevacizumab significantly prolongs progression-free survival in patients with recurrent high-grade glioma, it does not confer an overall survival advantage."

Clinical • Journal • Retrospective data • Review • Brain Cancer • Glioma • Malignant Glioma • Oncology • Solid Tumor

Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) Initial commercial launches in Germany and the UK planned to commence in Q2 CY2025; and (ii) Potential for approval from the U.S. Food and Drug Administration (FDA) of ONS-5010 in Q3 CY2025."

FDA approval • Launch Europe • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD (GlobeNewswire) - "Outlook Therapeutics...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. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity....The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA."

FDA filing • PDUFA • Wet Age-related Macular Degeneration

Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration (GlobeNewswire) - "Outlook Therapeutics, Inc...today 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)...The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA."

FDA filing • Wet Age-related Macular Degeneration

NORSE EIGHT: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3 | N=400 | Completed | Sponsor: Outlook Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2025 and Provides Corporate Update (GlobeNewswire) - "Resubmission of the ONS-5010 BLA targeted for Q1 CY2025; Initial commercial launches in Germany and the UK planned to commence in Q2 CY2025; and Potential for US FDA approval of ONS-5010 in Q3 CY2025."

FDA approval • FDA filing • Launch Europe • Age-related Macular Degeneration

Outlook Therapeutics Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD (GlobeNewswire) - P3 | N=400 | NORSE EIGHT (NCT06190093) | Sponsor: Outlook Therapeutics, Inc. | "Outlook Therapeutics, Inc...today announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting...Mean BCVA at baseline was 58.8 ETDRS letters for the ONS-5010 group and 59.9 letters for the ranibizumab group. ONS-5010 demonstrated mean BCVA improvements of +3.3, +4.2 and +5.5 letters at Months 1, 2, and 3 respectively. The difference in mean BCVA between ONS-5010 and ranibizumab was -1.009 letters (95% confidence interval, -2.865, 0.848), meeting the noninferiority margin at Month 3 (p=0.0043) (applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval)...Anatomical response was similar between treatments, with a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes and -127.3 microns for the ranibizumab group."

P3 data • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Complete Twelve Week Efficacy and Safety Results of NORSE EIGHT Clinical Trial (GlobeNewswire) - P3 | N=400 | NORSE EIGHT (NCT06190093) | Sponsor: Outlook Therapeutics, Inc. | "ONS-5010 demonstrated noninferiority to ranibizumab at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025...Applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval, the noninferiority margin was met at week 12 (p=0.0043)...NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm...Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12...Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025."

FDA filing • Launch Europe • P3 data • Wet Age-related Macular Degeneration

Outlook Therapeutics Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update (GlobeNewswire) - "Upcoming Anticipated Milestones: Final efficacy data from NORSE EIGHT expected in January 2025. Initial commercial launches in Europe planned to commence in first half of CY2025; and Potential for US FDA approval of ONS-5010 in second half of CY2025."

FDA approval • Launch Europe • P3 data • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces NICE Recommendation of LYTENAVA (bevacizumab gamma) for the Treatment of Wet AMD (GlobeNewswire) - "Outlook Therapeutics, Inc...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....'Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025...'"

Launch Europe • NICE • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

ONS-5010 (bevacizumab-vikg) Safety and Efficacy in Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "In the prescribed treatment plan, ONS-5010 exhibited strong effectiveness in improving or stabilizing visual acuity and was also well tolerated. Bevacizumab and ranibizumab displayed a comparable safety profile. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.]."

Journal • Age-related Macular Degeneration • Diabetic Retinopathy • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Outlook Therapeutics Reports Completion of Patient Dosing in the ONS-5010 Pivotal Phase 3 NORSE TWO Trial (GlobeNewswire) - "Outlook Therapeutics, Inc...reported today that it has administered the final dose to the last patient enrolled in its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (wet AMD). Topline data are expected to be reported for NORSE TWO in the third calendar quarter of 2021...'Following the upcoming data readout, we look forward to our planned new BLA submission for wet AMD in the first quarter of calendar 2022.'"

BLA • P3 data: top line • Trial primary completion date • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial (GlobeNewswire) - P3 | N=400 | NORSE EIGHT (NCT06190093) | Sponsor: Outlook Therapeutics, Inc. | "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. Upon the completion of analysis of the final results of NORSE EIGHT, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025....ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025."

FDA filing • P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

NICE backs first ophthalmic bevacizumab for NHS use (pharmaphorum) - "Outlook Therapeutics' Lytenava has become the first ophthalmic formulation of VEGF inhibitor bevacizumab to be cleared for use by the NHS in England and Wales for treating wet age-related macular degeneration (AMD). It is believed to be the first time that Lytenava (bevacizumab gamma) has been cleared for reimbursement in any European country, coming after the marketing approvals for the drug in the UK and EU earlier this year. Cost-effectiveness watchdog NICE has recommended Lytenava as an option for wet AMD in adults who have signs of recent disease progression, no permanent structural damage to the central fovea, and best-corrected visual acuity in the affected eye of between 6/12 and 6/96."

NICE • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Outlook Therapeutics Participates in a Virtual Investor CEO Connect Segment (GlobeNewswire) - "Outlook Therapeutics, Inc...announced that Russell Trenary, President and CEO of Outlook Therapeutics participated in a Virtual Investor CEO Connect segment. As part of this segment, Mr. Trenary provided an overview of the Company’s recent accomplishments and highlighted near-term value driving milestones as the Company works toward the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD."

Clinical • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Incidence of Anti-VEGF Intravitreal Injections for Non–FDA Approved Indications (AAO 2024) - "Conclusion A significant number of patients received anti-VEGF injections for non–FDA approved indications, the most common being bevacizumab. Future FDA approval of bevacizumab-vikg may decrease access to bevacizumab for non–FDA approved indications."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

ONS-5010-008: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Outlook Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces Completion of Enrollment in NORSE EIGHT Clinical Trial (GlobeNewswire) - "Outlook Therapeutics...announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required before expected resubmission of the Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010."

Enrollment closed • Special protocol assessment • Wet Age-related Macular Degeneration

Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update (GlobeNewswire) - "Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024; Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024; Resubmission of the ONS-5010 BLA targeted for Q1 CY2025; Initial commercial launches in Europe planned to commence in first half of CY2025; and Potential for US FDA approval of ONS-5010 in second half of CY2025."

Enrollment status • FDA approval • FDA filing • Launch Europe • P3 data: top line • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces UK MHRA Marketing Authorization of LYTENAVA (bevacizumab gamma) for the Treatment of Wet AMD (GlobeNewswire) - "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. LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK....This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025."

Launch Europe • MHRA approval • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Outlook Therapeutics(R) (NASDAQ:OTLK) Participates in Virtual Investor "What This Means" Segment Hosted by JTC Team (ACCESSWIRE) - "JTC Team...today released a Virtual Investor 'What This Means' segment featuring Outlook Therapeutics, Inc. (Nasdaq:OTLK), a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases. As part of this 'What This Means' segment, Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, discusses the Company's recently received European Commission Marketing Authorization for LYTENAVA (bevacizumab gamma) for the treatment of wet AMD."

Clinical • Age-related Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Outlook Therapeutics Receives European Commission Marketing Authorization for LYTENAVA (bevacizumab gamma) for the Treatment of Wet AMD (GlobeNewswire) - "Outlook Therapeutics...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.....The application for European Commission Marketing Authorization of LYTENAVA (bevacizumab gamma) is a mixed application grounded on Article 8.3 of Directive 2001/83/EC and is based on the results from Outlook’s wet AMD clinical program, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE - as well as studies and peer reviewed literature substituting or supporting certain tests and studies....Advancing toward commercial launch of LYTENAVA (bevacizumab gamma) in EU expected in calendar Q1 2025."

EMA approval • Launch Europe • Wet Age-related Macular Degeneration

Outlook Therapeutics Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD (GlobeNewswire) - "Outlook Therapeutics...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). The submission was completed under the new International Recognition Procedure (IRP)....The MAA submission is supported by results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE."

European regulatory • Wet Age-related Macular Degeneration

National Anti-VEGF Utilization for Conditions without U.S. Food and Drug Administration Approval: An IRIS Registry Study (ARVO 2024) - "We compared the number of patients and eyes that received bevacizumab, ranibizumab, aflibercept, and brolucizumab for FDA and non-FDA approved indications. A significant number of patients receive anti-VEGF injections for non-FDA approved indications, nearly two-thirds of whom received bevacizumab. FDA approval of bevacizumab-vikg may prohibit medication coverage (as a low cost repackaged option is no longer available) for patients with non-FDA approved indications affecting roughly 1 in 7 patients receiving anti-VEGF injections."

Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration