Switching to the Biosimilar Ranibizumab-nuna for the Intravitreal Treatment of Retinal Diseases - a Real-World Study

INTRODUCTION: Following the expiration of ranibizumab's (Lucentis) patent, the biosimilar ranibizumab-nuna (Byooviz) offers an alternative intravitreal medication with identical indications. However, real-world data on its efficacy remain limited. This study aimed to investigate the efficacy and safety of retinal disorders in patients who were switched from Lucentis to Byooviz.

METHODS: This retrospective, single-center study assessed adult patients previously treated with intravitreal Lucentis and switched to Byooviz. We evaluated structural and functional outcomes based on Snellen visual acuity (VA), fundoscopy, and optical coherence tomography (OCT) parameters, and treatment safety. Disease activity was classified as active or inactive, with neovascular activity defined as retinal pigment epithelial detachments, intra- or subretinal fluid, subretinal hyperreflective material, or macular hemorrhage on OCT or fundoscopy.

RESULTS: Between June 2021 and December 2024, we identified 31 patients, 21 (67.7%) of whom were female. Median (IQR, range) age was 82 (76.5 to 85.5, 49 to 91) years. The most common indication was neovascular age-related macular degeneration (61.3%), followed by macular edema (ME) due to retinal vein occlusion (22.6%), diabetic ME (9.7%), and secondary choroidal neovascularization (6.5%). Right and left eyes were nearly equally represented (48.4% vs. 51.6%). The median (IQR) injection numbers were 15 (10 to 40) for Lucentis and 8 (5 to 10.5) for Byooviz. After the switch, VA improved in 8 eyes (25.8%), was unchanged in 10 (32.3%), and worsened in 13 (41.9%). Disease activity decreased in 6 eyes (20%), increased in 3 (10%), and remained stable in 22 (70%). Treatment intervals shortened in 8 (25.8%) patients and extended in 14 (45.2%). No cases of endophthalmitis or other complications occurred.

DISCUSSION: Switching from Lucentis to Byooviz was generally well tolerated, with anatomical disease stability maintained in most patients. Certain decline in VA is also be observed in real-world outcomes for Lucentis and may reflect underlying disease progression rather than reduced efficacy of the biosimilar. Overall, Byooviz seems to be a viable alternative for patients previously treated with Lucentis.