Abstract / Summary
To evaluate the safety, efficacy and immunogenicity of biosimilar aflibercept (MYL-1701P) in participants with diabetic macular oedema who completed the 52-week global phase III trial and were enrolled in an extension study. In a 20-week, multicentre, open-label extension study at 15 sites in India, safety and efficacy were assessed in 52 participants who received three doses (2 mg intravitreal) of MYL-1701P either continuing on MYL-1701P (continuation arm) or switching to it from reference aflibercept (switch arm). The primary outcome was safety, assessed by the incidence of treatment-emergent adverse events (TEAEs). The secondary outcome was efficacy and included change in visual acuity (best corrected visual acuity (BCVA) based on Early Treatment Diabetic Retinopathy Study (ETDRS) letters) and central subfield thickness ((CST); by spectral-domain optical coherence tomography). Of the 52 participants enrolled, 46 completed week 76. Participants in both arms had comparable baseline characteristics. Incident TEAEs were noted in 9/29 participants in the continuation arm and 7/23 in the switch arm. No participant reported treatment-induced or boosted antidrug antibodies. The adjusted mean difference in BCVA change between baseline of parent study and week 76 (end of extension study) was -1.20 (2.95) ETDRS letters (90% CI -6.15 to 3.75) and from baseline of extension study to week 20 (week 76-parent study) was 1.59 (1.1) (90% CI -0.26 to 3.43). The adjusted mean difference in CST from baseline of parent study to week 76 was -15.9 (38.07) µm (90% CI -80.47 to 48.62) and from baseline of extension study to its end was 13.53 (16.13) µm (90% CI -13.86 to 40.92). The study had certain limitations, including participation from one geographical area, an open-label design and small number of participants. Despite the limited number of exposures in the switch arm, it still constituted a reasonable exposure, and similar safety, efficacy and immunogenicity profiles were observed between those who continued receiving MYL-1701P and those who switched from reference aflibercept to MYL-1701P in the 20-week extension study of the pivotal trial. NCT04674800, NCT03610646.
Primary Source
BMJ open ophthalmology
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