Biosimilar aflibercept MYL-1701P maintains safety and efficacy in diabetic macular oedema over 76 weeks

Diabetic macular oedema (DMO) is a leading cause of vision loss in working-age adults, stemming from diabetes-induced retinal microvascular damage and increased vascular permeability. Current standard-of-care involves intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents like aflibercept, which effectively reduce fluid leakage and improve vision. However, the high cost of these biologics can limit patient access and treatment adherence. Biosimilars offer a cost-effective alternative, and validating their long-term safety and efficacy is crucial for expanding treatment options for DMO.

This 20-week, multicentre, open-label extension study, conducted across 15 sites in India, assessed the safety and efficacy of biosimilar MYL-1701P in 52 participants with DMO. These participants had previously completed a 52-week global phase III trial. Participants received three intravitreal doses of MYL-1701P 2 mg either by continuing on MYL-1701P (continuation arm, n=29) or by switching from reference aflibercept (switch arm, n=23). The primary outcome was safety, evaluated by the incidence of treatment-emergent adverse events (TEAEs). Secondary efficacy outcomes included changes in best corrected visual acuity (BCVA) using ETDRS letters and central subfield thickness (CST) via spectral-domain optical coherence tomography.

Of the 52 participants enrolled, 46 completed the 76-week study period (including the parent study). Baseline characteristics were comparable between the continuation and switch arms. Incident TEAEs were reported in 9/29 participants in the continuation arm and 7/23 in the switch arm, indicating a similar safety profile. Importantly, no participant developed treatment-induced or boosted antidrug antibodies. Efficacy measures showed stable visual acuity and retinal thickness. > The adjusted mean difference in BCVA change from the parent study baseline to week 76 was -1.20 (2.95) ETDRS letters (90% CI -6.15 to 3.75), and from the extension study baseline to week 20 (week 76 of parent study) was 1.59 (1.1) (90% CI -0.26 to 3.43). The adjusted mean difference in CST from parent study baseline to week 76 was -15.9 (38.07) µm (90% CI -80.47 to 48.62), and from extension study baseline to its end was 13.53 (16.13) µm (90% CI -13.86 to 40.92).