Efficacy and Safety of Biosimilar Ranibizumab (Razumab) versus Innovator Ranibizumab (Lucentis) in BRVO: A Retrospective Study from Eastern India

Bivas Bala, Debdulal Soren, Sima Biswas
Author(s)
1Associate Professor, Department of Ophthalmology, Calcutta National Medical College, Kolkata, West Bengal, India. 2Junior Resident, Department of Ophthalmology, Calcutta National Medical College, Kolkata, West Bengal, India. 3Assistant Professor, Department of Gynecology & Obstetrics, Rampurhat Govt. Medical College, West Bengal, India.

Abstract

Background: To compare the efficacy and safety of intravitreal Razumab and Lucentis in the management of macular edema secondary to branch retinal vein occlusion (BRVO). Material and Methods: In this comparative study, 92 eyes of 92 patients with BRVO-associated macular edema were included, with 47 eyes receiving intravitreal Razumab and 45 eyes receiving Lucentis. Baseline demographic and clinical characteristics, including age, gender, best-corrected visual acuity (BCVA), and central retinal thickness (CRT), were comparable between groups. Patients were followed for 6 months. Primary outcomes included changes in BCVA and CRT, while secondary outcomes assessed safety and injection burden. Results: Both groups demonstrated significant improvement in visual and anatomical outcomes at 6 months. Mean BCVA improved from 46.6 ± 10.1 to 64.3 ± 9.5 letters in the Razumab group and from 45.9 ± 9.1 to 65.2 ± 8.9 letters in the Lucentis group (p < 0.001 for both), with no significant difference in mean visual gain between groups (16.3 ± 6.7 vs. 17.0 ± 7.2 letters; p = 0.63). Similarly, CRT decreased significantly in both groups, with reductions of 184.7 ± 81.4 µm in the Razumab group and 189.6 ± 78.3 µm in the Lucentis group (p < 0.001 for both), without significant intergroup difference (p = 0.77). Safety outcomes were comparable, with no serious ocular or systemic adverse events reported. Minor adverse events, including Subconjunctival hemorrhage and transient intraocular pressure elevation, were infrequent and similar between groups. The mean number of injections was also comparable (4.3 ± 0.8 vs 4.2 ± 0.9; p = 0.58). Conclusion: Intravitreal Razumab and Lucentis demonstrate comparable efficacy and safety in the treatment of BRVO-related macular edema, with significant improvements in visual acuity and retinal thickness over 6 months. These findings support Razumab as a cost-effective alternative to Lucentis without compromising clinical outcomes.

Keywords: BRVO, macular edema, Razumab, Lucentis, Ranibizumab, anti-VEGF, biosimilar.

Outline