Drug Database
RA

ranibizumab (LUBT 010 / ranibizumab, Lupin / LUBT010)

✓ Approved

Lupin Limited · VEGFA · Monoclonal Antibodies

What is ranibizumab?

ranibizumab is a monoclonal antibodies developed by Lupin Limited. It is approved for therapeutic indications via injectable (others) or intraocular injection.

Drug Profile

Brand NamesLUBT 010, ranibizumab, Lupin, LUBT010
CompanyLupin Limited
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetVEGFA
RouteInjectable (Others), Intraocular Injection
StatusApproved

Mechanism of Action

Molecular Targets

ranibizumab acts on 1 molecular target:

VEGFAvascular endothelial growth factor A (VPF, MVCD1)
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Therapeutic Indications

ranibizumab is developed for 7 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Eye disordersDiabetic retinal oedema✓ Approved
Eye disordersDiabetic retinopathy✓ Approved
Eye disordersMyopia✓ Approved
Eye disordersRetinal vein occlusion✓ Approved
Eye disordersRetinopathy of prematurity✓ Approved

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Related Research Articles

PubMedOphthalmic epidemiology2026-11-11

Visual and Anatomical Outcomes of Intravitreal Ranibizumab Combined with Focal/Grid Macular Laser for Center-Involved Diabetic Macular Edema: A Real-World Retrospective Cohort Study.

Xie Jinglin J, Zhang Yang Y, Peng Qi Q, Xu Xiaohong X et al.

Center-involved diabetic macular edema (CI-DME) is a major cause of vision loss in non-proliferative diabetic retinopathy. Anti-VEGF therapy is standard, but adjunctive focal/grid macular laser may reduce treatment burden in selected eyes. This study evaluated ranibizumab combined with individualized focal/grid laser in Chinese patients with CI-DME. In this retrospective propensity-matched cohort study, 196 eyes with NPDR-related CI-DME received ranibizumab plus focal/grid macular laser (n = 98) or focal/grid laser alone (n = 98) and were followed for 6 months. Baseline OCT and fluorescein angiography were reviewed to characterize DME morphology. The primary outcome was change in best-corrected visual acuity (BCVA); secondary outcomes included central macular thickness (CMT), ≥0.2 LogMAR gain, injection frequency, and adverse events. At month 6, BCVA improved more in the combination group than in controls (-0.17 ± 0.12 vs. -0.10 ± 0.09 LogMAR; p = 0.002). A ≥ 0.2 LogMAR gain occurred in 57.6% versus 31.8% of eyes (p = 0.001). CMT reduction was also greater with combination therapy (152.3 ± 71.5 μm vs. 86.7 ± 68.2 μm; p < 0.001), and ≥20% CMT reduction occurred in 65.2% versus 38.4% of eyes. Nearly half of combination-treated eyes required no additional injections beyond the initial three. Adverse events were rare and similar. Ranibizumab combined with individualized focal/grid macular laser improved visual and anatomical outcomes, reduced injection burden, and showed acceptable safety in selected CI-DME eyes.

PubMedBMC ophthalmology2026-11-10

Incidence rate and factors associated with periprocedural hypoxia during bedside intravitreal ranibizumab injection for retinopathy of prematurity: a multicenter retrospective study.

Al-Hadlaq Abdulaziz M AM, Nagy Waleed M A WMA, Elwan Shaaban A M SAM

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become an established treatment for type 1 retinopathy of prematurity (ROP). However, evidence regarding intraprocedural hypoxia during bedside intravitreal injection remains limited. This study evaluated the incidence, severity, and predictors of hypoxia during intravitreal ranibizumab injection for treatment-requiring ROP. This retrospective multicenter observational study included premature infants with treatment-requiring ROP who underwent bedside intravitreal ranibizumab injection under topical anesthesia between July 2020 and June 2026 in neonatal intensive care units across the Al Qassim region, Saudi Arabia. Continuous pulse oximetry was used during the procedure and for 30 min afterward. Hypoxia was classified as mild (oxygen saturation 85-89%), moderate (80-84%), or severe (< 80%). Demographic, perinatal, maternal, and ophthalmic variables were analyzed. Logistic regression was performed to identify factors associated with hypoxia. Seventy-four premature infants out of 1430 were included. The mean gestational age was 27.5 ± 2.2 weeks, the mean birth weight was 986.8 ± 265.8 g, and the mean postmenstrual age at treatment was 36.6 ± 2.2 weeks. Hypoxia occurred in 12 infants (16.2%; 95% CI, 8.7-26.6%), including 10 (13.5%) with mild hypoxia and 2 (2.7%) with moderate hypoxia; no episodes of severe hypoxia were observed. Lower gestational age (OR 0.51, 95% CI 0.35-0.76; P = 0.001), lower birth weight (OR 0.991 per gram increase, 95% CI 0.984-0.997; P = 0.004), and longer duration of oxygen therapy (OR 1.35, 95% CI 1.03-1.77; P = 0.028) were associated with hypoxia in univariate analysis. After adjustment, birth weight remained the principal predictor of increasing hypoxia severity. At follow-up, regression of ROP was achieved in 60 infants (81.1%), while 4 (5.4%) required repeat ranibizumab injection and 10 (13.5%) underwent adjunctive laser photocoagulation. Bedside intravitreal ranibizumab injection under topical anesthesia was associated with a low incidence of transient hypoxia, and no severe oxygen desaturation events occurred. Lower birth weight and lower gestational age were associated with an increased risk of hypoxia. These findings support the short-term cardiorespiratory safety of bedside ranibizumab injection in premature infants while emphasizing the importance of continuous physiological monitoring, particularly in extremely low-birth-weight infants. NCT07701759 obtained on July 8, 2026.

PubMedRomanian journal of ophthalmology2026-11-09

Role of combined therapy of intravitreal Ranibizumab and topical Dorzolamide in the Treatment of foveal schisis maculopathy: A case report and review of literature.

Raj Anuradha A, Jain Sahil S, Singla Anurag A, Dazine Easther E

Description of unusual management of the foveal schisis maculopathy. Case report and review of literature. We report the case of a 25-year-old man who presented with a gradual, painless diminution of vision that persisted for 3 months. The best-corrected visual acuity (BCVA) was 20/40 and 20/120 in the right and left eyes, respectively. Fundus examination revealed bilateral spoke-wheel pattern maculopathy, and optical coherence tomography (OCT) confirmed schisis at the inner nuclear and outer plexiform layers. An important morphological and functional improvement resulted from sequential bilateral intravitreal anti-VEGF injections (0.3 mg Ranibizumab), one in each eye, followed by topical 2% dorzolamide eye drops, which helped to stabilize the disease. In this case, anti-VEGF treatment followed by topical dorzolamide demonstrated anatomical and functional improvement. This combined therapy stabilized the condition, suggesting its efficacy. X-linked foveal retinoschisis (XLRS) is a hereditary juvenile retinal degeneration that presents with mild to moderate bilateral vision loss, with a spoke-wheel pattern on fundoscopy. As of now, there is no established effective treatment for XLRS; however, carbonic anhydrase inhibitors (CAIs) have demonstrated efficacy in reducing schisis cavities by absorption through the retinal pigment epithelium. The role of anti-VEGF therapy in treating X-linked retinoschisis (XLRS) is also limited and may offer temporary improvements in foveal retinoschisis. In foveal schisis maculopathy, combination therapy with anti-VEGF and topical dorzolamide may be considered. This therapy offers notable improvements in foveal retinoschisis by restoring macular architecture and serves as a maintenance treatment. Further research with larger cohorts is needed to optimize therapy regimens.

PubMedJournal of extracellular vesicles2026-11-05

First-in-Human Regulatory T Cell-Derived Exosomes Plus Ranibizumab for Refractory nAMD.

Tian Ying Y, Qian Zhuyun Z, Fan Shuzhen S, Wang Jianmin J et al.

Persistent fluid despite intravitreal anti-vascular endothelial growth factor (VEGF) treatment remains common in neovascular age-related macular degeneration (nAMD). Regulatory T cell-derived exosomes (TregExo) have preclinical immunomodulatory activity. To evaluate the safety and maximum tolerated dose (MTD) of intravitreal autologous TregExo plus ranibizumab in refractory nAMD. Design, Setting, and Participants: Single-centre, prospective, open-label phase 1a trial using a 3+3 dose-escalation design at Hebei General Hospital. Four participants with persistent intraretinal or subretinal fluid despite at least 3 consecutive monthly intravitreal anti-VEGF injections were treated. One intravitreal injection of autologous TregExo (planned doses, 0.05, 0.5, or 1.5 mg) coformulated with ranibizumab, 0.5 mg. The primary outcome was safety and MTD determination. Dose-limiting toxicity (DLT) was prespecified as severe sterile intraocular inflammation, sustained intraocular pressure greater than 30 mm Hg, loss of more than 15 ETDRS points, or another serious ocular adverse event within 30 days. Exploratory visual and anatomic outcomes were assessed through day 90. Four participants were treated: 3 at 0.05 mg and 1 at 0.5 mg. No DLT or intraocular inflammation occurred in the 0.05-mg cohort, and intraocular pressure remained stable. Two low-dose participants improved from ETDRS scores of 3 and 9 at baseline to 35 at day 90; Patient 1 had a macular thickness reduction from 318.2 to 253.9 µm. The 0.5-mg participant developed sterile intraocular inflammation with vision loss and a large intraretinal cyst, which resolved after local corticosteroid therapy. Dose escalation was stopped, and 0.05 mg was the protocol-defined MTD. Intravitreal autologous TregExo plus ranibizumab had an identifiable dose ceiling: 0.05 mg was tolerated, whereas 0.5 mg was associated with DLT. Further controlled evaluation of lower-dose TregExo-based adjunctive therapy in refractory nAMD is warranted. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2500095798.

PubMedSurvey of ophthalmology2026-11-05

Endophthalmitis risk after intravitreal anti-vascular endothelial growth factor injection using prefilled versus vial-drawn syringes: An agent-specific systematic review and meta-analysis.

Leung Rachel Ya Yuan RYY, Lam Phoebe Cheuklam PC, Ma Alfred Sze Hon ASH, Fong Angie Hon Chi AHC et al.

Post-injection endophthalmitis is a rare, vision-threatening complication of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy. Prefilled syringes may reduce contamination by eliminating point-of-care drug transfer, but prior pooled comparisons may be confounded by anti-VEGF agent, drug mix, and calendar era. We systematically reviewed anti-VEGF studies comparing prefilled with vial-drawn syringes (PROSPERO CRD420251090070). Fourteen comparative studies included 6.2 million injections; nine vial-only cohorts informed the temporal anchoring analysis. Using arm-based generalized linear mixed models, prefilled syringes were associated with lower endophthalmitis odds: the agent-matched odds ratio was 0.62 (95% CI 0.49-0.77) and the all-agent estimate 0.53 (0.43-0.65). Effects were concordant for ranibizumab (0.61) and aflibercept (0.58), with no significant between-agent difference, and culture-positive endophthalmitis was likewise lower with prefilled syringes (OR 0.33). The agent-matched absolute risk difference was approximately 1 fewer case per 10,000 injections. Findings were robust to small-study adjustment and persisted after linear calendar-year adjustment (OR, 0.60; 95% CI, 0.53-0.69), with no evidence of a linear year association (P=.93). Prefilled-syringe delivery is associated with approximately one-third lower odds of endophthalmitis than vials-consistent across agents, robust to bias adjustment, and calendar-years adjustments-while acknowledging the residual-confounding limits inherent to observational data.

PubMedRetina (Philadelphia, Pa.)2026-10-30

Submacular Hemorrhage Requiring Procedural Intervention During Anti-VEGF Therapy for Neovascular Age-Related Macular Degeneration in Japan: The JTY Three-Center Real-World Incidence Study.

Inoda Satoru S, Takahashi Hidenori H, Azuma Keiko K, Terao Ryo R et al.

To estimate the incidence and clinical characteristics of submacular hemorrhage (SMH) requiring procedural intervention during anti-VEGF therapy for neovascular age-related macular degeneration (nAMD) in a Japanese multicenter real-world setting, with exploratory comparison according to the preceding anti-VEGF agent. This multicenter retrospective real-world incidence study reviewed surgical records from three Japanese centers to identify SMH requiring gas injection or vitrectomy during ongoing anti-VEGF treatment. The denominator was the total number of anti-VEGF injections for nAMD during the same period. Incidence per 1,000 injections and site-adjusted incidence rate ratios (IRRs) were estimated using quasi-Poisson regression. Among 47,358 injections, 54 SMH events requiring procedural intervention were identified (1.14 per 1,000 injections). Median final BCVA after procedural treatment was 1.00 logMAR (Snellen equivalent, 20/200), compared with 0.46 logMAR before SMH (approximately 20/60). PCV accounted for 39 events (72.2%), and prior SMH was documented in 12 eyes (22.2%). Crude incidence was 2.20 for ranibizumab, 1.09 for brolucizumab, 1.08 for aflibercept, and 0.24 for faricimab. Using aflibercept as the reference, IRRs were 1.83 for ranibizumab (95% confidence interval [CI], 0.73-4.59; P = 0.195), 0.91 for brolucizumab (95% CI, 0.25-3.28; P = 0.883), and 0.20 for faricimab (95% CI, 0.01-3.16; P = 0.251). SMH requiring procedural intervention during anti-VEGF therapy for nAMD was uncommon but visually severe; among affected eyes, PCV accounted for 72.2% of events. Exploratory drug-specific analyses did not demonstrate significant adjusted differences among anti-VEGF agents. Future patient-level studies should evaluate subtype-specific incidence, hemorrhagic recurrence, and polyp-directed treatment strategies in PCV-rich populations.

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