Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence.

Purpose: To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD). Methods: Retrospective observational study in nAMD patients, who were treated with IRM or BRM (3 loading doses followed by pro re nata (PRN). Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) along with safety analysis. Secondary outcomes measures were changes in the subretinal fluid (SRF) and intraretinal fluid (IRF). Results: Inclusion criteria were satisfied in 164 eyes (60.74%). A total of 87 eyes were treated with IRM, and 77 eyes received BRM. Baseline BCVA was 0.57±0.27 logMAR in IRM group and 0.61±0.25 in the BRM group. At 3, 6, 9, and 12 months BCVA was 0.27±0.22 (p<0.0001), 0.34±0.23 (p<0.0001), 0.39±0.25 (p<0.0001), and 12 months 0.41±0.23 (p<0.0001) in the IRM group and 0.24±0.16 (p<0.0001), 0.27±0.16 (p<0.0001), 0.34±0.17 (p<0.0001), 0.38±0.18 (p<0.0001) in the BRM group. Baseline CMT was 420.39±54.45 µm in IRM group and 407.82±53.07 µm in BRM group. At 3, 6, 9, and 12 months, CMT decreased to 258.28±20.4 µm (p<0.0001), 268.38±19.5 µm (p<0.0001), 269.51±32.41 µm (p<0.0001), and 278.28±16.56 µm (p<0.0001) in the IRM group and 258.84±17.47 µm (p<0.0001), 265.69±17.29 µm (p<0.0001), 273.64±23.13 µm (p<0.0001), and 283.09±19.66 µm (p<0.0001) in the BRM group. Similar improvements in IRF and SRF levels in the patients were noted in both groups. Required number of doses of IRM and BRM was similar over the 12 month period in both groups. A similar profile of adverse events was noted in both the groups. Conclusion: Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD.

Brolucizumab in Neovascular Age-Related Macular Degeneration - Indian Real-World Experience: The BRAILLE Study - Fifty-Two-Week Outcomes.

Purpose: To report the 52-week real-world efficacy and safety outcomes of brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in Indian eyes. Patients and Methods: A retrospective, multicentre chart analysis of 82 eyes of 82 patients with nAMD (switch therapy: 65 eyes; treatment-naïve: 17 eyes) with 52-week follow-up data was performed. Pro-re-nata re-treatment was offered based on visual and tomographic criteria. Changes in best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central-subfield thickness (CST), and pigment epithelial detachment (PED) were the key outcome measures, coupled with the safety profile. Results: The mean age of the study population was 67.65 (±10.67) years, with 57 male patients (69.5%). The study's mean number of injections was 4.8 (± 0.77). After brolucizumab therapy, the BCVA improved significantly at weeks 4 (P<0.001), and maintained up to week 52 (P<0.001). The CST also reduced significantly at all the visits (Baseline: 413.6 ± 64.6 µm; 52-week: 292.37 ± 13.5 µm; P<0.001). Significantly fewer eyes demonstrated residual SRF (P<0.001) and IRF (P<0.001) at all visits, starting with week 12 and continuing until week 52. The PED resolution was significant from week 24 through week 52 (P=0.004). Each of the 82 eyes received four injections of brolucizumab, with 63.4% (52 eyes) receiving a fifth dose and only 17.1% requiring a sixth. Mild intraocular inflammation (IOI) was seen in three eyes (3.66%) that resolved conservatively. One patient (1.2%) developed mild fever that subsided with oral medications. Conclusion: The 52-week BRAILLE study demonstrates that brolucizumab is effective and safe in nAMD eyes in a real-world setting. Brolucizumab treatment can reduce the therapeutic burden in patients with nAMD due to its rapid, sustained efficacy and favourable safety profile.

Comparison of Innovator vs. Biosimilar Ranibizumab in Treating Diabetic Macular Edema: A Multicenter Retrospective Study.

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 follow-up 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 µm 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 µm) was comparable to that in the bRBZ group at 6 months (105 ± 187 µm) (p = 0.69). There was no difference in the mean number of injections taken (3.81 ± 1.2 in iRBZ vs. 3.55 ± 1.2 in bRBZ) (p > 0.05) between groups. Vision at baseline was the only factor associated with vision at last follow-up after adjusting for CMT at baseline, type of injection, and number of injections. CONCLUSIONS: Biosimilar RBZ is similar to innovator RBZ in improving vision and reducing CMT in eyes with DME in the short term.

Modified surgical technique for lamellar macular holes with lamellar hole-associated epiretinal proliferation (LHEP).

PURPOSE: To evaluate the efficacy and safety of lamellar hole-associated epiretinal proliferation embedding technique with modification in the surgical management of degenerative lamellar macular hole (LMH). METHODS: There is retrospective case series of consecutive eyes who underwent pars plana vitrectomy with LHEP embedding with internal limiting membrane (ILM) inversion technique for degenerative LMH. Primary outcome measure was improvement in foveal contour and central foveal thickness (CFT). Secondary outcome measures were changes in best corrected visual acuity (BCVA), status of outer retinal layers (external limiting membrane-ELM & ellipsoid zone-EZ) and complications. RESULTS: Ten eyes were operated by modified LHEP embedding technique. Mean age was 65.8 ± 5.3 years with 1:1 male to female ratio. Simultaneous cataract surgery was done in 70% cases. Mean follow-up duration was 7.9 ± 0.87 months. 80% (8/10) eyes had improvement in foveal contour to normal appearance with increase in residual foveal thickness from 90.2 ± 26.83 microns to CFT of 226 ± 35.44 microns at 6 months (p = 0.0054). Mean BCVA improved from 0.69 ± 0.19 logMAR to 0.32 ± 0.29 logMAR (p = 0.012). External limiting membrane (ELM) and ellipsoid zone (EZ) defects were present in four eyes (40%) pre-operatively. At the final visit 2 eyes (20%) had persistent defect in both ELM & EZ. None of the eyes progressed to full-thickness macular hole following surgery. CONCLUSIONS: The modified surgical technique of LHEP Embedding with ILM inversion is demonstrated to provide satisfactory results with reduced risk of complications for degenerative LMH. Larger and long-term follow-up studies are needed to establish this technique as standard surgical procedure for LMH with LHEP.

A novel video overlay guided enlargement of area of ILM peeled versus inverted flap technique: A long-term study in large macular holes.

BACKGROUND/AIM: To compare the intra-operative video overlay guided enlargement of Area of ILM peeled (AIP) more than three Disc Diameter (DD) versus the inverted flap technique in large (>400 µm ) Full Thickness Macular Holes (FTMH). METHODS: Retrospectively, 127 cases of large FTMHs divided into two groups (i) Group A (n = 62)-intra-operative video-overlay guided enlargement of AIP > 3DD performed and (ii) Group B (n = 65)-Inverted flap technique was done. Mean Best Corrected Visual Acuity (BCVA), hole closure rate and postoperative foveal anatomy were noted on Optical Coherence Tomography (OCT). RESULTS: Mean Minimal Diameter of Macular Hole (MDMH) were 632.05 ± 146.62 µm (A) and 677.24 ± 152.08 µm (B). Hole closure rate were 93.55% (A) and 96.92% (B). Mean preoperative BCVA was 1.07 ± 0.37 Log MAR (A) and 0.94 ± 0.23 Log MAR (B). Mean postoperative BCVA at 3 months were 0.73 ± 0.22 Log MAR (A) and 0.83 ± 0.24 Log MAR (B). One-way ANOVA test showed statistically better visual improvement in Group A at 3 months (p = 0.02), 6 months (p = 0.045), 12 months (p = 0.002), and 24 months (p = 0.011). Chi square test revealed Type I pattern of hole closure was statistically more in Group B (p < 0.001). Delayed Recovery of Outer Retinal Layers was more in group B (Pearson Chi square test, p = 0.039). CONCLUSION: Anatomically, macular hole closure rate as well as closure pattern was better in Group B. But functional improvement was better in Group A.

Long-term clinical outcomes of submacular blood removal with isolated autologous retinal pigment epithelium-choroid patch graft transplantation in long-standing large-sized submacular hematomas: An Indian experience.

Purpose: To study the outcomes of submacular blood removal with isolated autologous full-thickness retinal pigment epithelial (RPE)-choroid patch graft transplantation in long-standing large-sized submacular hematomas in Indian population. Methods: A retrospective study was done on eight consecutive patients of long-standing large-sized submacular hematoma from east India. In all cases, 23G vitrectomy was performed with the induction of retinal detachment (performed with or without 38G or 41G subretinal cannula) and a temporal 180° retinectomy was done. Submacular blood along with choroidal neovascular tissue was removed. A full-thickness RPE-choroid autologous patch graft was taken from a relatively healthy quadrant at the mid periphery and then the graft transferred under perfluorocarbon liquid (PFCL) to place it in the subfoveal area. Then, retina was re-attached using PFCL and laser completed. Silicone oil (5000 cst) was used as a tamponade. Post-operatively, wide-field fundus photographs (Optos), serial optical coherence tomography (OCT), indocyanine green angiography (ICGA), and multifocal electroretinography (ERG) were done. Results: The mean age of the patients at presentation was 67.88 ± 10.03 years. Mean pre-operative best corrected visual acquity (BCVA) was 2.64 ± 0.3 log MAR and mean postoperative BCVA was 1.095 ± 0.27 log MAR (P < 0.05). The mean follow-up was 20 ± 16.57 months. ICG showed re-vascularization of translocated graft in all at 2 months. Multifocal ERG (after 6 months) showed some waveform in all. None of the cases developed re-bleed. Conclusion: Removal of submacular blood and neovascular membrane with autologous RPE-choroid graft is a viable option in cases with long-standing large submacular hematomas.

New Innovative Approaches for Difficult Retained Intraocular Foreign Bodies.

PURPOSE: To describe innovative ways of removal of complicated difficult large retained intraocular foreign bodies (RIOFBs). SETTINGS: Both cases were treated at Disha Eye Hospitals, Kolkata, a tertiary eye hospital in eastern India. METHODS: Innovative approaches were taken to remove 2 difficult RIOFBs. In the first case, a large RIOFB was just beyond the posterior exit wound, trapped in the sclera. A 23-G MVR blade was used to create multiple radial releasing scleral nicks and bimanually moving the RIOFB into the vitreous cavity using a bent-tip 24G needle and magnet, and the RIOFB was removed through the limbal section. In the second case, a 21-mm long thick nail was deeply embedded in the superior sclera with partial localised retinal detachment with its bulbous end just behind the clear lens. A lasso technique was used to remove the RIOFB without lens touch. RESULTS: In the first case, the patient finally achieved logMAR 0.2 vision after silicone oil removal and glued scleral fixation of the intraocular lens. In the second case, the patient finally achieved logMAR 0.3 vision after silicone oil removal and phacoemulsification with intraocular lens implantation. CONCLUSION: Each case of RIOFB is unique and challenging. Here, innovative techniques are helpful to rescue these difficult RIOFB situations, which can result in excellent outcomes.