SSGJ-601 versus Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion: 52-Week Results from a Phase 3 Study.

PURPOSE: To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar SSGJ-601 compared with ranibizumab in patients with macular edema secondary to branch retinal vein occlusion (BRVO).

DESIGN

A multicenter, randomized, double-masked, active-controlled phase 3 clinical study.

PARTICIPANTS

A total of 351 patients with macular edema secondary to BRVO were enrolled.

METHODS

Evaluable patients (N=351) were randomized to receive intravitreal SSGJ-601(1.25mg per eye, Q4W) or intravitreal ranibizumab (0.5mg per eye, Q4W) from day 1 through week 20 (6 injections in total), and treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria from week 24 to week 48. All patients completed their end-of-study visit at week 52.

MAIN OUTCOME MEASURES: The primary efficacy endpoint was the Least Squares (LS) mean difference in change in best-corrected visual acuity (BCVA), measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from baseline to week 24. Secondary efficacy endpoints, safety, pharmacokinetics, immunogenicity and change in VEGF concentration of SSGJ-601 were also analyzed.

RESULTS

Demographic and baseline characteristics and exposure to treatment were similar between groups. In the study eye, SSGJ-601 was non-inferior to ranibizumab in improving the LS mean in BCVA letter count from baseline to week 24 (17.6 (0.66) vs. 18.2 (0.65) letters, -0.6 with 95%CI: (-2.4,1.3), P for non-inferior<0.0001), thus, the primary clinical efficacy end point was met. At each time point, the proportions of patients achieving BCVA gains of ≥5, ≥10, and ≥15 letters in the SSGJ-601 group were non-inferior to those in the ranibizumab group. Drug-related TEAEs (11.4% vs. 12.5%) and SAEs (6.9% vs. 9.1%) were comparable in the two treatment groups. A low incidence of binding antidrug antibodies was observed in SSGJ-611 group.

CONCLUSIONS

This study supports the conclusion of no clinical meaningful differences in efficacy, safety, and immunogenicity between SSGJ-601 and ranibizumab in patients with macular edema secondary to BRVO. Additionally, treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria resulted in sustained benefits in visual and anatomical outcomes.