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

• Published in: Clinical ophthalmology (Auckland, N.Z.) Vol. 16; pp. 4303 - 4313
• Main Authors: Chakraborty, Debdulal, Maiti, Aniruddha, Sheth, Jay U, Mondal, Soumen, Boral, Subhendu, Nandi, Krishnendu, Sinha, Tushar Kanti, Das, Arnab
• Format: Journal Article
• Language: English
• Published: New Zealand Taylor & Francis Ltd 01.01.2022; Dove; Dove Medical Press
• Subjects: age related macular degeneration; brolucizumab; Demographics; FDA approval; inflammation; Macular degeneration; Medical imaging; Monoclonal antibodies; Normal distribution; Original Research; Patients; Population; Statistical analysis; Vascular endothelial growth factor; Visual acuity; United States > US; Basel Switzerland; Switzerland; India; brolucizumab; inflammation; age-related macular degeneration
• ISSN: 1177-5467; 1177-5483; 1177-5483
• DOI: 10.2147/OPTH.S395577

To report the 52-week real-world efficacy and safety outcomes of brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in Indian eyes. 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. 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 ( <0.001), and maintained up to week 52 ( <0.001). The CST also reduced significantly at all the visits (Baseline: 413.6 ± 64.6 µm; 52-week: 292.37 ± 13.5 µm; <0.001). Significantly fewer eyes demonstrated residual SRF ( <0.001) and IRF ( <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 ( =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. 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.