A comparative, double-blind, randomized, multicenter Phase III study has established the non-inferiority of OPTIMAB®, a biosimilar of ranibizumab, to the innovator ranibizumab (Lucentis) in treating neovascular age-related macular degeneration (nAMD). The study, conducted across 19 centers in India, compared the clinical efficacy and safety of OPTIMAB® with that of the innovator product in patients with nAMD.
The study enrolled 152 patients with treatment-naive choroidal neovascularization (CNV) secondary to AMD. Participants were randomized in a 3:1 ratio to receive either OPTIMAB® (n=114) or innovator ranibizumab (n=38), administered as a 0.5 mg intravitreal injection every four weeks for a total of three doses. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters in Best Corrected Visual Acuity (BCVA) from baseline at week 12.
Efficacy Outcomes
The results demonstrated that the proportion of patients who lost fewer than 15 letters in BCVA at week 12 was comparable between the OPTIMAB® group (100%) and the innovator ranibizumab group (100%). This met the primary endpoint, establishing the non-inferiority of OPTIMAB®. The BCVA in the study eye improved significantly from 42.5 ± 11.42 letters at baseline to 54.3 ± 13.15 letters at week 12 in the OPTIMAB® group (P<0.001), and from 46.5 ± 12.01 letters at baseline to 59.4 ± 13.46 letters at week 12 in the innovator ranibizumab group (P<0.001). There was no significant difference in the change in BCVA at week 12 as compared to baseline in the two groups (OPTIMAB® – 11.8 ± 9.18 vs innovator ranibizumab – 12.9 ±10.29 letters; P = 0.5509).
Central Subfoveal Thickness (CSFT) also significantly improved from baseline to week 12 in both groups. In the OPTIMAB® group, CSFT improved from 323.2 ± 125.82 μm at baseline to 238.4 ± 84.50 μm at week 12 (P<0.001), and in the innovator ranibizumab group, it improved from 318.8 ± 94.51 μm at baseline to 245.7 ± 96.01 μm at week 12 (P<0.001). No significant difference was observed in the change in CSFT from baseline to week 12 between the two groups (OPTIMAB®, −76.6 ± 89.03; innovator ranibizumab, −73.1 ± 92.23 μm; P = 0.8422).
Safety and Immunogenicity
The safety profile of OPTIMAB® was comparable to that of the innovator ranibizumab. In the safety population (N = 152), 20 (13.2%) patients reported at least one treatment-emergent adverse event (TEAE). Among these, 17 patients (14.9%) in the OPTIMAB® group experienced 19 TEAEs, while 3 patients (7.9%) in the innovator ranibizumab group reported 4 TEAEs. The majority of TEAEs were ocular in nature, with vitritis being the most frequently reported event. Notably, none of the patients in either group developed anti-ranibizumab antibodies.
Clinical Implications
The study findings suggest that OPTIMAB® is a biosimilar to ranibizumab with comparable efficacy, safety, and immunogenicity in patients with nAMD. The availability of biosimilar ranibizumab is expected to increase patient access to effective treatments for nAMD while reducing the financial burden on healthcare systems. According to the World Health Organization, AMD is a leading cause of blindness globally, affecting millions worldwide. Anti-VEGF therapies like ranibizumab have revolutionized nAMD treatment, but their high cost has limited accessibility.
Study Limitations
The study's limitations include a 12-week follow-up period and a 3:1 randomization ratio, which may limit the assessment of long-term safety and efficacy. Longer-term studies with a more balanced design are recommended to confirm these results.
Conclusion
OPTIMAB® has the potential to improve access to nAMD treatment for a broader population of patients while reducing the overall financial burden on healthcare systems. The study supports its potential utilization as a biosimilar product for ranibizumab.
