Beovu (brolucizumab-dbll) / Novartis, Santen, China Medical System - LARVOL DELTA

Adoption patterns of anti-vascular endothelial growth factor therapies in retinal disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Real-world adoption of anti-VEGF therapies differs markedly across retinal diseases and agents. Aflibercept demonstrated sustained long-term use, while faricimab showed rapid early uptake. Changes in agent-specific utilization occurred alongside substantial growth in the absolute number of treated patients over the study period, underscoring the importance of interpreting drug-specific trajectories in the context of overall treatment activity."

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

Understanding anti-vascular endothelial growth factor medications: chemical properties, costs, and side effects. (PubMed, J Med Life) - "This narrative review addressed the fact that the pharmacological properties, safety profiles, and cost-effectiveness of the currently marketed anti-VEGF intravitreal agents (i.e. bevacizumab, ranibizumab, aflibercept, brolucizumab, pegaptanib, and recently faricimab) differ and therefore, each of these agents, have their own unique molecular structure, target specificity, duration of action in the eye, and systemic circulation, each of which will affect the dosing intervals and treatment burden as well as the safety and adverse events associated with each drug. While anti-VEGF therapies are highly effective, the outcomes regarding safety, efficacy, and cost depend heavily on the study design and reflect the actual treatment paradigm and continuum of care within the healthcare system. The various attributes of agents should help personalize a patient's treatment approach while also addressing potential challenges related to the safety, efficacy, and longevity of..."

Adverse events • Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Efficacy of Brolucizumab in the Treatment of Patients with Diabetic Macular Edema and Diabetic Retinopathy: A Systematic Review and Meta-Analysis. (PubMed, J Clin Med) - "In the three DME trials, brolucizumab achieved a greater reduction in CST/CSFT. It may be useful for selected DME patients, while its role in PDR requires longer-term evidence."

Journal • Retrospective data • Review • Diabetic Macular Edema • Diabetic Retinopathy • Inflammation • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Vasculitis

Molecular Determinants of Intravitreal Anti-VEGF Durability: Drug Architecture, Intraocular Pharmacokinetics, Target Biology and Treatment Resistance. (PubMed, Int J Mol Sci) - "Trial evidence for ranibizumab, aflibercept, conbercept, brolucizumab and faricimab shows that extended dosing can arise from greater starting exposure, altered binding architecture or pathway expansion without a proportionate change in intrinsic ocular half-life. We propose that durability be defined as a time-to-threshold phenotype integrating active target-site exposure, biological demand, anatomical recurrence, all treatment-related procedures and safety. Standardised estimands, longitudinal human ocular sampling, spatial exposure methods and externally validated mechanism-informed models are needed to make molecular durability comparable and clinically actionable."

Journal • PK/PD data • Review • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Gene Therapies • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Novartis India Limited has announced the signing of an exclusive promotion and distribution agreement with Novartis Healthcare Private Limited (NHPL) on September 8, 2026. (Indian Pharma Post) - "This strategic collaboration marks the company's entry into the ophthalmology therapy segment and serves to expand its overall commercial portfolio in the country...Under the terms of the agreement, Novartis India Limited has acquired the exclusive rights to promote and distribute NHPL's retina portfolio across India. The portfolio includes key products Accentrix (ranibizumab) and Pagenax (brolucizumab). In exchange for these exclusive rights, the company will pay an upfront consideration of Rs. 10 crores to NHPL."

Licensing / partnership • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Risk of intraocular hemorrhage among exudative age-related macular degeneration patients treated with different anti-VEGF agents. (PubMed, PLoS One) - "In this large nationwide cohort, intraocular hemorrhage requiring vitrectomy after anti-VEGF therapy for exudative AMD was rare but occurred more frequently with brolucizumab and aflibercept than with ranibizumab. Although unlikely to be the primary determinant of anti-VEGF selection, these findings provide adjunctive safety information that may be considered when counseling and monitoring selected patients."

Journal • Retrospective data • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-world retinal vasculitis events reported with FDA-approved intravitreal anti-VEGF and complement inhibitor agents: an analysis of FAERS data. (PubMed, Retina) - "FAERS reporting identified RVAEs across included intravitreal therapies, but cannot establish incidence, causality, or comparative risk, underscoring the need for vigilant reporting and ongoing post-marketing safety surveillance."

FDA event • Journal • Real-world evidence • Inflammation • Ocular Inflammation • Retinal Vein Occlusion • Vasculitis

Early retinal volume changes after switching to brolucizumab in refractory neovascular age-related macular degeneration. (PubMed, Front Ophthalmol (Lausanne)) - "This retrospective observational study primarily focused on the evaluation of early anatomical changes and intraocular inflammation (IOI) following the switch to intravitreal injection of brolucizumab (IVBr) in patients with neovascular age-related macular degeneration (nAMD) who were refractory to aflibercept or ranibizumab and unable to extend injection interval beyond 10 weeks while resolving retinal fluids. Switch to brolucizumab therapy resulted in early anatomical changes. An increase in CRV despite improvement in central foveal parameters may represent a potential warning sign of brolucizumab-associated IOI and warrants further prospective validation."

Journal • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Vasculitis • Wet Age-related Macular Degeneration

Choroidal Changes after Intravitreal Aflibercept, Faricimab, Brolucizumab, and High-Dose Aflibercept in Treatment-Naïve Neovascular Age-Related Macular Degeneration. (PubMed, Ophthalmol Sci) - "These findings suggest drug-specific patterns of choroidal remodeling, potentially influenced by molecular and pharmacologic properties, warranting further prospective evaluation to determine their clinical implications. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

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

Rational design, expression and refolding of a novel bispecific antibody to simultaneously target VEGF-A and Ang-2 for inhibition of angiogenesis. (PubMed, J Pharm Sci) - "Here, based on current knowledge, we report the first systematic design of multiple VEGF-A/Ang-2 tandem scFv constructs derived from brolucizumab and faricimab, respectively, with variations in VH/VL orientation and linker architecture. Differential scanning calorimetry confirmed improved conformational stability after optimized redox-assisted refolding (Tm ≈ 59.8°C). Collectively, these findings demonstrate that integrating structure-guided construct selection with systematic refolding screening enables rational optimization and improved developability of Fc-free tandem scFv bispecific antibodies."

Journal • Oncology

Comparison of Retinal Nonperfusion in Diabetic Macular Edema Treated with Brolucizumab Versus Aflibercept: A KINGFISHER Trial Analysis. (PubMed, Am J Ophthalmol) - P3 | "In this treated cohort, NPI did not show a statistically significant change over 52 weeks in eyes receiving monthly brolucizumab or aflibercept, with no statistically significant difference detected between agents. The absence of significant reperfusion despite intensive VEGF inhibition may suggest non-VEGF-mediated mechanisms."

Journal • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Signals of drug-related retinal artery occlusion: a multi-country retrospective study from a spontaneous reporting system. (PubMed, Front Med (Lausanne)) - "Strong signals, as indicated by the BCPNN algorithm, were observed for mepivacaine, brolucizumab, and pegaptanib. This study characterizes the reporting patterns and signal strength of RAO across multiple drug classes using pharmacovigilance data. These findings provide real-world evidence to enhance clinical awareness and support safer prescribing practices, while emphasizing the need for further validation in controlled studies."

Journal • Retrospective data • Anesthesia • Oncology

Community-Level Variation in On-Label Versus Off-Label Anti-VEGF Use and Medicare Part B Spending. (PubMed, Retina) - "Despite uniform reimbursement, significant community-level differences exist in on-label anti-VEGF use within Medicare Part B. These gradients produce billions of dollars in differential spending and raise questions of access, equity, and value-based care."

Journal • Medicare • Reimbursement • US reimbursement • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Intravitreal Brolucizumab for Diabetic Macular Edema: Outcomes in Treatment-Naive and Anti-VEGF-Switched Eyes over 48 Weeks. (PubMed, J Clin Med) - "However, the switched group was older and had a more heterogeneous treatment history, including prior intravitreal corticosteroid treatment. The findings should therefore be interpreted as exploratory."

Journal • Diabetic Macular Edema • Inflammation • Ophthalmology

Proteomic profiling reveals treatment-dependent inflammatory signatures and identifies biomarkers of refractory age-related macular degeneration. (PubMed, Front Pharmacol) - "1) To confirm the presence of angiogenic and inflammatory biomarkers before (in the naive state) and after two anti-VEGF injections; and 2) to characterize the inflammatory response according to the type of anti-VEGF used (ranibizumab, aflibercept, brolucizumab, or faricimab). Our results indicate that anti-VEGFA therapy shapes AMD-associated inflammation; therefore, the choice of anti-VEGFA therapy remains important in reducing secondary inflammatory effects. Furthermore, the detection of free VEGF is dependent on the assay used."

Biomarker • Journal • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders

Access to Intravitreal Anti-VEGF Drugs in Persons with Medicare Advantage Compared with Medicare Fee-For-Service. (PubMed, Ophthalmology) - "Beneficiaries enrolled in MA were less likely to receive higher cost, anti-VEGF drugs, raising concerns about reduced beneficiary access to newer more expensive anti-VEGF drugs in MA."

Journal • Medicare • Reimbursement • US reimbursement • Ophthalmology

Alternative posology for brolucizumab: a 6-week loading regimen is as effective as a 4-week regimen for the treatment of nAMD. (PubMed, BMJ Open Ophthalmol) - "This integrated modelling approach predicted that reducing the loading regimen of brolucizumab 6 mg treatment to two or three doses every 6 weeks is expected to result in similar efficacy outcomes, resulting in regulatory approval of this alternative dosing regimen in several countries."

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

Paradoxical angiogenic activation under anti-VEGF therapy: tip cell hyper-sprouting and vessel remodeling drive inefficient vascularization in multiscale tumor simulations. (PubMed, BMC Cancer) - "Anti-VEGF therapy does not simply prune vessels - it triggers dysregulated sprouting and architectural instability. The disconnect between vessel quantity and functionality reveals a state of "angiogenic inefficiency," where increased vascular metrics mask underlying dysfunction. These findings redefine vascular response to therapy and highlight the need to evaluate vessel quality - not just density - in treatment assessment."

Journal • Oncology • Solid Tumor

Efficacy of anti-VEGF single-chain variable fragment AAV-based gene therapy in a laser-induced choroidal neovascularisation mouse model. (PubMed, Mol Ther Adv) - "Anti-VEGF therapies are widely used, with brolucizumab, a humanized monoclonal single-chain variable fragment (scFv) that inhibits VEGF, showing promise due to its high molar concentration and superior ability to dry the retina...Vector genomes were detectable by qPCR at 12 weeks, and electroretinography showed no obvious functional deficit. These findings support further evaluation of sustained AAV-mediated anti-VEGF delivery for nAMD."

Journal • Preclinical • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis • Wet Age-related Macular Degeneration

Comparison of Intraocular Inflammation Associated with High-Dose Intravitreal Anti-Vascular Endothelial Growth Factor Agents: A Real-World Disproportionality Analysis. (PubMed, Ocul Immunol Inflamm) - "This study aimed to compare ocular adverse events, especially intraocular inflammation, associated with brolucizumab, faricimab, and 8 mg aflibercept. IOI profiles differ significantly among high-dose anti-VEGF agents. Comprehensive evaluation of individual patients' risk factors is recommended to guide clinical decision-making."

Journal • Real-world evidence • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Vasculitis

Long-term analysis of intravitreal brolucizumab in recalcitrant cases of chronic central serous retinopathy complicated by neovascularization (pachychoroid neovasculopathy). (PubMed, Indian J Ophthalmol) - "Intravitreal brolucizumab administered PRN effectively resolves persistent fluid and reduces PED in chronic CSC with PNV refractory to prior treatments, while maintaining stable visual acuity and demonstrating a favorable safety profile through 2 years of follow-up."

Journal • Retrospective data • Retinal Disorders

Genetic factors associated with response to as-needed brolucizumab treatment for exudative age-related macular degeneration. (PubMed, Jpn J Ophthalmol) - "ARMS2 A69S may serve as a predictor of recurrence and number of additional injections in as-needed brolucizumab therapy for exudative AMD."

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

One-year outcomes of treat-and-extend regimen with intravitreal aflibercept 8 mg for treatment-naïve neovascular age-related macular degeneration. (PubMed, Jpn J Ophthalmol) - "Loading phase treatment followed by a TAE regimen with intravitreal aflibercept 8 mg appears to be effective for improving visual acuity and ameliorating exudative changes in eyes with nAMD. However, there might be cases in which exudative changes cannot be adequately controlled with injections of aflibercept 8 mg. Moreover, careful monitoring is required due to the potential development of IOI associated with retinal vasculitis during the loading phase."

Journal • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis • Wet Age-related Macular Degeneration

Temporal Adoption Patterns of Anti-VEGF Therapies for AMD, DME, and RVO in a Large Real-World Cohort (ARVO 2026) - "We evaluated real-world utilization for ranibizumab, bevacizumab, aflibercept, brolucizumab, and faricimab using standardized behavior-change metrics. Understanding how treatment choices evolve in the real world can help clinicians, health systems, and policymakers anticipate demand, plan for access, and prepare for the arrival of emerging medications and biosimilars. Ultimately, these insights may improve patient care by ensuring that effective therapies are available when and where they are needed."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Temporal trends in architecture, formulation determinants and targeting strategy of monoclonal antibodies and their potential association with adverse ocular events (ARVO 2026) - "Intravitreal mAbs mM: Bevacizumab=0.168 (vs. systemicT1= p0.785), Ranibizumab=0.207 (vs. systemicT1= p0.775), Brolucizumab=4.6 ! (vs. systemicT3= p<0.0001), Faricimab=0.805 (vs. systemicT4= p<0.001)...Conclusions Ocular adverse events were not correlated with mere mAb structural trends - but rather with expression of target-epitope on ocular cells or roaming immune cells, breach of ocular immune privilege by ICIs, off-target breakdown of ADC-linker and high formulation molarity - a risk factor for aggregation and adverse immune response. So far, severe ocular adverse events prompted FDA in-label warning for ICIs, ADCs and intravitreal anti-VEGFs (Brolucizumab)."

Adverse events • IO biomarker • Ocular Inflammation • Ophthalmology • CD20 • CTLA4 • EGFR • ERBB3 • HER-2 • PD-1 • TNFA