Efficacy of Switching to Biosimilar Ranibizumab in Eyes Initially Treated with Reference Ranibizumab for Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion.

PURPOSE: To assess the efficacy of ranibizumab-eqrn for neovascular age-related macular degeneration (nAMD), macular edema from retinal vein occlusion (RVO), and diabetic macular edema (DME) in eyes switched from reference ranibizumab.

METHODS

Single-center, retrospective chart review of eyes which received at least three ranibizumab followed by at least three ranibizumab-eqrn injections over a two-year period. Eyes which were initially treated with alternative anti-VEGF agents were eligible for inclusion. Eyes that received surgery, laser, or intravitreal corticosteroids were excluded. Central foveal thickness (CFT) was measured at the initial and final visit in the ranibizumab and ranibizumab-eqrn groups for a subset of eyes. Primary outcome measures included best available visual acuity (VA) and CFT. Secondary outcome measures included number of intravitreal injections, follow-up time, and treatment interval. Analysis was performed using Python.

RESULTS

6233 Eyes from 4935 patients treated between June 6 2022 and June 6 2024 were included. 4692 (75.3%) eyes had nAMD, 1078 (17.3%) eyes had RVO, and 463 (7.4%) eyes had DME. Eyes received 7.1 ± 2.7 (total: 44500) ranibizumab injections over 10.5 ± 2.5 months. After switching, eyes received 5.8 ± 2.2 (total: 35840) ranibizumab-eqrn over 8.5 ± 1.7 months. Mean change in visual acuity was -1.0 ± 16.0 letters for ranibizumab vs. -0.6 ± 13.8 letters for ranibizumab-eqrn (p = 0.15). Mean change in CFT in a subset of 100 eyes was 0.81 ± 56.3 microns for ranibizumab vs. -7.2 ± 50.6 microns for ranibizumab-eqrn (p = 0.39). Mean injection interval increased from 8.3 weeks to 8.9 weeks in the ranibizumab vs. the ranibizumab-eqrn groups for all indications (p < 0.01).

CONCLUSIONS

In this large real-world study, eyes with nAMD, RVO, and DME switched to ranibizumab-eqrn from reference ranibizumab demonstrated similar efficacy.