Ranibizumab biosimilar noninferior to Lucentis for DME

The ranibizumab biosimilar (Vicentis) was noninferior to ranibizumab (Lucentis) for visual acuity (VA) and central subfield thickness (CSFT) in patients with diabetic macular edema, according to a poster presented at AAO 2021.

In a noninferiority double-blind clinical trial, 154 eyes of 154 patients with diabetic macular edema were randomized to receive a single intravitreal injection of ranibizumab (n = 77) or ranibizumab biosimilar (n = 77)

Visual acuity, CSFT, and glycemic control were similar between the groups at baseline. At 1 month, VA and CSFT significantly improve in both groups. Changes in CSFT were 115 microns in the Lucentis group and 104 microns in the ranibizumab biosimilar group. Visual acuity changed by 4 letters and 3.2 letters, respectively. Changes in VA and CSFT were not statistically significant between the groups.

Intraocular inflammation was not observed in any of the eyes.

Reference
Modarres M, et al. Safety and Efficacy of a Ranibizumab Biosimilar Medication vs. Lucentis for Treatment of DME: A Randomized Clinical Trial. Presented at: AAO 2021.