Real-Life Comparison of Off-Label Intravitreal Biosimilar Bevacizumab-awwb and Reference Bevacizumab in Treatment-Naïve Patients with Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion

Purpose: To compare the functional, anatomical, and safety results of intravitreal biosimilar bevacizumab-awwb (IVB-awwb; Mvasi®) and reference bevacizumab (IVB; Altuzan®) in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO). Methods: This non-randomized, retrospective, real-life study included 191 treatment-naïve eyes (62 nAMD, 96 DME, and 33 RVO) of 150 patients receiving three monthly IVB and IVB-awwb loading doses. Baseline and final (one month after the third injection) best-corrected visual acuity (BCVA; logMAR) and central macular thickness (CMT; µm) of the eyes with nAMD, DME, and RVO, disease activity rates for nAMD, and overall endophthalmitis rates were compared between IVB and IVB-awwb groups. Results: The mean baseline and final BCVA and CMT were comparable for nAMD (32 vs. 30 eyes), DME (47 vs. 49 eyes), and RVO (14 vs. 19 eyes) in IVB and IVB-awwb groups. The final nAMD activity rates were 53.1% and 63.3% in the groups, respectively (p=0.578). In DME eyes, BCVA significantly improved in the IVB group (p=0.002) with no significant difference in the IVB-awwb group (p=0.152), and the mean change in BCVA was -0.180.38 and -0.090.45 logMAR, respectively (p=0.033). Culture-negative endophthalmitis (n=2; 2.0% overall) was observed only in the IVB-awwb group (p=0.498). Conclusion: This real-life study suggests that intravitreal biosimilar bevacizumab-awwb could yield comparable or worse but no better results than reference bevacizumab in eyes with nAMD, DME, and macular edema secondary to RVO. Further randomized studies are required to elucidate the efficacy and safety of IVB-awwb.