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

Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA (bevacizumab-vikg) - "The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval....The Company expects to continue engaging in discussions with the FDA to further clarify the Agency’s views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010/LYTENAVA toward potential U.S. approval."

FDA event • Wet Age-related Macular Degeneration

Outlook Therapeutics Seeks FDA Clarification After Drug Rejection (AD HOC NEWS) - "The company submitted an application for a Type A Meeting with the Food and Drug Administration (FDA) yesterday. This move is a direct response to the Complete Response Letter the agency issued on December 30, 2025, which rejected the drug's application for treating wet age-related macular degeneration (wet AMD)....The primary goal of the requested meeting is to address the FDA's concerns without embarking on entirely new clinical trials."

FDA event • Wet Age-related Macular Degeneration

Repurposing biosimilars, rethinking costs: a framework for sustainable drug pricing for repurposed bevacizumab for intravitreal injections. (PubMed, Eur J Health Econ) - "While off-label bevacizumab has been standard in clinical practice for over a decade, recently, a repurposed formulation (brand name: Lytenava®, Outlook Therapeutics Ltd), developed specifically for vascular retinal conditions, received marketing approval from the European Medicines Agency...Ultimately, this approach contributes to the development of pricing strategies that balance affordability for healthcare systems with sustainable returns for manufacturers while fostering the broader development of repurposed treatments. The findings of this paper aim to advance the dialogue on equitable pricing for repurposed therapies."

Journal • Pricing • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Macular Edema • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD (GlobeNewswire) - "FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA....In the CRL, the FDA noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application, however the FDA has not indicated what type of confirmatory evidence would be acceptable."

CRL • Wet Age-related Macular Degeneration

Network Meta-Analysis of Bevacizumab Gamma Versus Competing Interventions for Treating Neovascular Age-Related Macular Degeneration in the United Kingdom. (PubMed, J Mark Access Health Policy) - "The included anti-VEGF treatments were ranibizumab, aflibercept, faricimab, and bevacizumab gamma. At 12 months, all anti-VEGF treatments were similarly efficacious to ranibizumab 0.5 mg every four weeks (Q4W) in terms of CFB in BCVA, the proportion of patients gaining 15 or more letters, and the proportion of patients losing less than 15 letters (except for ranibizumab 0.5 mg every 12 weeks [Q12W] and ranibizumab 0.5 mg pro re nata [PRN]). Bevacizumab gamma provided similar improvements in visual acuity to other anti-VEGF treatments."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • 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) - "The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD."

FDA filing • PDUFA • Wet Age-related Macular Degeneration

Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 (GlobeNewswire) - "ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)."

FDA filing • Wet Age-related Macular Degeneration

Outlook Therapeutics Requests Type A Meeting with FDA (GlobeNewswire) - "...Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD....The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA."

FDA event • Age-related Macular Degeneration

Outlook Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD). (The Manila Times) - "In the CRL, the FDA advised that, because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness."

CRL • Wet Age-related Macular Degeneration

Financial Highlights for the Fiscal Third Quarter Ended June 30, 2025 (GlobeNewswire) - "For the fiscal third quarter ended June 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $20.2 million, or $0.55 per basic and diluted share, and $1.5 million of revenue. Revenue consisted of the initial sales into Germany and the UK for LYTENAVA where title to the product has transferred to the distributor. This compares with net loss attributable to common stockholders of $0.89 per basic and diluted share for the same period last year, and no revenue."

Sales • Wet Age-related Macular Degeneration

ONS-5010/LYTENAVA (bevacizumab-vikg) Clinical and Regulatory Update (GlobeNewswire) - "The FDA set a 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..."

PDUFA • Wet Age-related Macular Degeneration

bevacizumab gamma (Lytenava) is accepted for use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD). Bevacizumab gamma offers an additional treatment choice in the therapeutic class of vascular endothelial growth factor inhibitors. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower."

Reimbursement • Wet Age-related Macular Degeneration

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