AAO Posters Investigate Ranibizumab Biosimilar Impact on Patient Outcomes

Two studies presented at the American Academy of Ophthalmology (AAO) annual meeting in Chicago, Illinois, demonstrated the impact that a ranibizumab biosimilar (SB11; Byooviz) can have on patient outcomes.

Post Hoc Analysis to Define Baseline Factors for Clinical Outcomes

A post hoc analysis of a phase 3 trial found that baseline age, best corrected visual acuity (BCVA), and central subfield thickness (CST) were the best baseline factors to predict visual acuity and anatomical outcomes when managing neovascular age-related macular degeneration (wet AMD) with the biosimilar or the reference product (Lucentis).¹

The purpose of the study was to determine factors associated with efficacy outcomes after 1 year of a phase 3 trial comparing SB11 with Stelara in patients with wet AMD. The phase 3 study was randomized and double-masked. During the post hoc analysis, associations between baseline factors and treatment responses of BCVA and CST at week 52 were examined using a linear regression model. A multivariable analysis was used to judge the relevance of each baseline factor.

The linear regression model estimated that patients would experience a lower gain in BCVA of 1.9 letters and a greater CST reduction of 12.6 mcm at week 52 for each 10-year increment of the participants’ age. For every 5-year age increment, the model predicted 1.1 less letter of BCVA improvement.

For every 50-mcm greater baseline CST, the model forecasted about 35.5 mcm greater CST reduction by week 52. Additionally, a subgroup analysis of BCVA change by associated baseline factors demonstrated similar therapy effects within each subgroup between SB11 and the reference product.

Correlation Analysis Between Immunogenicity, Clinical Outcomes

A correlation analysis found that the immunogenicity profile of SB11 was low and very similar to the reference product in patients with wet AMD.²

The analysis examined a double-masked phase 3 trial that included 705 patients who were randomized to received monthly intravitreal injection of the biosimilar or reference product for up to 48 weeks. Efficacy data were assessed based on the patients’ antidrug antibody (ADA) status through week 52.

Cumulative incidence of an ADA-positive response was low and similar across treatment arms, with the immunogenicity result at week 52 coming to 14 (4.2%) for the biosimilar and 18 (5.5%) for the reference product.

Changes in BVCA and CST from baseline to week 52 were not associated with ADA status, while the difference between ADA-positive and ADA-negative status was 1.6 (95% CI, –2.7 to 5.8; P = .46) for BCVA and 2.9 (95% CI, –22.8 to 28.5; P = .83) for CST.

References

1. Woo SJ, Kim T, Oh IK, et al. A post hoc analysis of a phase 3 trial to define baseline factors associated with treatment outcomes of SB11 (ranibizumab biosimilar). Presented at: AAO 2022; September 30-October 3, 2022; Chicago, IL. Poster PO385.

2. Bressler NM, Kim T, Oh IK, et al. correlation analysis between immunogenicity and clinical outcomes of an approved ranibizumab biosimilar, Byooviz (SB11). Presented at: AAO 2022; September 30-October 3, 2022; Chicago, IL. Poster PO376.