Purpose: To assess the short-term efficacy and safety profile of intravitreal brolucizumab injection in Indian eyes with neovascular age-related macular degeneration (nAMD) under real-world conditions. Patients and Methods: This was a multicenter, retrospective chart review of 94 eyes of 94 patients with nAMD (treatment-naïve and switch-therapy) undergoing brolucizumab therapy. Re-treatment as per pro-re-nata protocol was performed based on fixed visual and tomographic criteria. The main outcome measures were changes in the best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central subfield thickness (CST), and pigment epithelial detachment (PED) along with safety analysis. Results: Of the 94 eyes, 20 eyes (21.3%) were treatment-naïve, whereas the rest 74 eyes (78.7%) underwent switch therapy. One hundred and twenty-six injections were given over a mean followup of 7.3 ± 2.2 (range 5-30) weeks. The BCVA improved significantly from 0.82 ± 0.5 LogMAR at baseline to 0.66 ± 0.5 LogMAR at the final visit (p < 0.0001). Significant reduction in CST was simultaneously noted (Baseline: 408.45 ± 65.63 µm; Final: 281.14 ± 37.74 µm; p < 0.0001). On qualitative analysis, resolution of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) was observed in 15.5%, 39.29%, and 23.81% of the eyes, respectively. The mean interval of repeat injection was 10.2 ± 2.1 weeks. Three episodes of ocular adverse drug reaction were reported, including two patients developing subretinal hemorrhage while one having a retinal pigment epithelial (RPE) tear. Notably, no intraocular inflammation (IOI) was seen in any of the eyes, and no systemic side effects were identified. Conclusion:In a real-world scenario, brolucizumab therapy is efficacious and safe in the management of nAMD over the short term. Further long-term studies are warranted to validate these findings. Additionally, lack of ocular inflammation after 126 brolucizumab injections in our Indian data is peculiar and underlines the necessity to explore the role of race and genetics in predisposing to/safeguarding against brolucizumab-related IOIs.

Introduction To assess the safety profile of the intravitreal ranibizumab biosimilar molecule, Razumab ® (Intas Pharmaceuticals, Ahmedabad, India) in chorioretinal disorders under real-world conditions. Methods This was a multicenter, retrospective chart review which included patients from 15 centers receiving intravitreal Razumab (IVRz) injections from 2016 to 2020. Patient demographics, ocular examination data, and detailed safety information regarding serious adverse events (SAE) or serious adverse drug reactions (sADR), and non-serious AEs (nsAE) or non-serious ADRs (nsADR) occurring within 1 month of IVRz injections were compiled. Results A total of 6404 eyes of 6404 patients received 9406 IVRz injections [mean (± SD) = 1.49 (± 0.63)] during 4.25 years. Adverse events were reported after 1978 injections (21.03%): 64.16% nsAE, 32.96% nsADR, 2.37% sADR, and 0.51% SAE. The most frequent adverse events were subconjunctival hemorrhage (8.2% of total injections), transient blurring of vision (6.5% of total injections), and mild ocular pain (5.27% of total injections). Serious ocular (31 cases with retinal pigment epithelial tears [0.33%], two cases of non-infectious vitritis [0.02%], and one case of endophthalmitis [0.01%]) and systemic (seven patients with non-fatal myocardial infarction [0.12%] and six patients with non-fatal cerebrovascular accident [0.09%]) adverse events were infrequent. Conclusion The study reports the largest pooled safety data on IVRz use in a real-world scenario. The results did not raise any new ocular or systemic safety concerns for the biosimilar agent, with the incidence and spectrum of adverse reactions similar to those reported with other anti-vascular endothelial growth factor (anti-VEGF) drugs. The real-world evidence suggests that IVRz is a safe anti-VEGF agent in the management of chorioretinal disorders. Supplementary Information The online version contains supplementary material available at 10.1007/s40123-021-00345-2.

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Purpose: To report the initial experience of managing treatment-resistant and treatment-naïve eyes with polypoidal choroidal vasculopathy (PCV) by using brolucizumab 6 mg. Methods: This was a retrospective multicentric series of all consecutive eyes with PCV treated with brolucizumab. Treatment resistance was defined as taking at least six prior anti-VEGF injections over the past 1 year and showing persistent disease activity in the form of intra (IRF) or subretinal fluid (SRF) or both. All patients were treated on a pro re nata (PRN) basis and followed up monthly. Retreatment was considered when either SRF or IRF were present at any time point during the study. Results: We included 21 eyes of 21 patients with PCV with a mean age of 65.1 ± 9.9 years, of which 16 eyes (76%) were treatment-resistant. The mean follow-up period from receiving the first brolucizumab was 27.3 ± 3.3 weeks. Of the 21 eyes, seven eyes (33%) received three injections during follow-up, 13 eyes (62%) received two injections, and one eye received one injection. The mean injection-free interval was 12 ± 1.2 weeks. The median pretreatment vision was 0.6 logMAR (IQR = 0.47–1 logMAR) and improved to 0.3 logMAR (IQR = 0.25–0.6 logMAR), whereas the mean macular thickness improved from 443 ± 60 mm at baseline to 289 ± 25 mm ( P < 0.001) at the last follow-up period. None of the eyes experienced any intraocular inflammation across 48 injection sessions Conclusion: Brolucizumab is safe and effective in controlling PCV disease in both treatment-resistant and treatment-naïve eyes.

Introduction: To compare the efficacy of innovator ranibizumab (iRBZ-Accentrix, Novartis, India) vs. biosimilar ranibizumab (bRBZ, Razumab-Intas, India) in eyes with diabetic macular edema (DME) in an Indian population. Methods: Data of patients with DME who underwent at least three injections of iRBZ or bRBZ and had a minimum of 6 months followup were obtained from an electronic database. Choice of injection depended upon the patient. Pro re nata (PRN) protocol from baseline was used with reinjections advised if the central macular thickness (CMT) was at least 300 lm and best corrected visual acuity (BCVA) was 20/40 or worse. Primary outcome measure was comparison of change in BCVA at 6 months between iRBZ and bRBZ. Results: We included 264 eyes in the iRBZ group and 69 eyes in bRBZ group, which were comparable for baseline characteristics. Mean BCVA improved from 0.64 ± 0.39 logMAR to 0.47 ± 0.31 logMAR (p \ 0.001) in the iRBZ group and from 0.71 ± 0.42 logMAR to 0.50 ± 0.29 logMAR in the bRBZ group (p \ 0.001) at 6 months. There were no differences in BCVA between the two groups (p [ 0.05 for all time points). The CMT reduction in the iRBZ group (120 ± 196 lm) was comparable to that in the bRBZ group at