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Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin's biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin's biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin's ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], −3.3% to 5.4% and per protocol population: 1.2%; 95% CI, −3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin's ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin's ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin's biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis®.

Background Intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF) agents is the standard of care for neovascular age-related macular degeneration (nAMD), but treatment resistance and incomplete fluid resolution remain challenges in refractory cases. This study investigates the real-world outcomes of faricimab in patients with previously treated refractory nAMD. Methods A prospective single center study was conducted involving patients with refractory nAMD treated with a loading dose of 3 IVI of faricimab 6 mg/0.05 ml, administered every four weeks. All patients included in this study had previously received a minimum of 3 consecutive intravitreal injections of other anti-VEGF. Main outcome measures included best-corrected visual acuity (BCVA) and OCT outcomes at follow-up time for 3 months. Results Thirty-five eyes of 35 patients were included. The BCVA (logMAR) improved from 0.84±0.49 to 0.76±0.49 at 3 months ( P = 0.025). The central macular thickness (CMT) decreased significantly from 447.65±161.46 µm to 327.33±147.78 µm at 3 months ( P < 0.001). The correlation analysis revealed that age and ellipsoid zone (EZ) discontinuity exhibited a weak positive correlation with the final BCVA ( P < 0.05). Baseline BCVA demonstrated a strong positive correlation with the final BCVA ( P < 0.05). Meanwhile, baseline CMT, intraretinal fluid (IRF), scar, and subretinal hyperreflective material (SHRM) showed a moderate positive correlation with the final BCVA ( P < 0.05). Multivariate logistic regression analysis demonstrated that baseline BCVA ( P = 0.032) and age ( P = 0.047) were independent predictors of final BCVA. Conclusion In the short term, faricimab led to significant improvements in BCVA and CMT, as well as reductions in retinal fluid, making it an effective treatment option for previously treated refractory nAMD with minimal adverse effects. Limitations include the single-arm design, small sample size, and lack of long-term durability assessment.

Introduction The aims of this work were to evaluate the real-world efficacy and safety of a loading dose of intravitreal faricimab in eyes with active neovascular age-related macular degeneration (n-AMD) or diabetic macular edema (DME) and to analyze the treatment outcome in relation to specific biomarkers. Methods Patients with active n-AMD or DME, treated with four monthly intravitreal injections of faricimab, were enrolled in this retrospective, uncontrolled study. Best-corrected visual acuity (BCVA), central subfield thickness (CST), presence of retinal fluid (RF) on optical coherence tomography (OCT), and adverse events were assessed at baseline and at weeks 4, 8, 12, and 16. Predefined biomarkers were evaluated at baseline (BL) and at last visit. Results Sixteen eyes of 15 patients with n-AMD (n-AMD group) and 15 eyes of 12 patients with DME (DME group) were included. Mean (± standard deviation) logarithm of minimum angle of resolution (logMAR) BL BCVA changed from 0.68 (± 0.43) to 0.53 (± 0.36; P  = 0.13) and from 0.51 (± 0.34) to 0.32 (± 0.24; P : 0.048) at week 16 in n-AMD and DME group, respectively. A statistically significant mean CST reduction was reported in both groups at last visit (n-AMD: − 166.5 μm; P  = 0.0009/DME: − 110.8 μm; P  = 0.0086). Seventy-five and 33% of eyes with n-AMD and DME respectively achieved complete RF resolution at last visit. Subfoveal inner and outer retinal damage correlated with a lower final BCVA in n-AMD group. The presence of large (> 100 μm) juxtafoveal microaneurysms (MAs) was significantly correlated with a higher chance of residual fluid in eyes with DME. Conclusions Both n-AMD and DME groups achieved satisfactory anatomical results after a loading-dose of intravitreal faricimab. BCVA improvement might be hampered by pre-existing retinal damage in eyes with n-AMD. Large, juxtafoveal MAs might represent a hallmark of a slower anatomical response to the treatment in eyes with DME.

Background To compare and assess the efficacy of three surgical methods for the treatment of acute submacular hemorrhage (ASH): pneumatic displacement with C2F6, in combination with intravitreal injection of bevacizumab and rtPA, pars plana vitrectomy (PPV) with intravitreal injection of gas (C2F6), bevacizumab and subretinal injection of recombinant tissue plasminogen activator (rtPA), pars plana vitrectomy (PPV) with intravitreal injection of gas (C2F6), bevacizumab and intravitreal injection of recombinant tissue plasminogen activator (rtPA). Methods The study included 85 patients with ASH. In the group without PPV (A), patients were treated with intravitreal injection of C2F6, bevacizumab and rtPA. In the second and third group, patients underwent a PPV, intravitreal injection of bevacizumab, pneumatic displacement with C2F6 and a subretinal (B) or intravitreal (C) injection of recombinant tissue plasminogen activator (rt PA). Results In group A, mean BCVA increased from preop logMAR 1.41 to 1.05, in group B from 1.46 to 1.28 and in group C from 1.63 to 1.33. In group A, CFT changed from 764 ± 340 μm at time point 0 to 246 ± 153 μm at time point 1, in group B from 987 ± 441 μm to 294 ± 166 μm and in group C from 642 ± 322 μm to 418 ± 364 μm. Patients had an average of 5 injections after surgery. Conclusion Our study demonstrates that the three methods are equally effective in improving the morphology and the BCVA of patients with ASH.