Trial reportBMJ open ophthalmology2026
Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial.
Trial report in BMJ open ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
A Multi Center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects With Diabetic Macular Edema Completed MYL-1701P-3001 Study.
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8 authors.
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Abstract
aimTo 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.
methodsIn 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).
resultsOf 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).
conclusionThe 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. TRIAL REGISTRATION NUMBER: NCT04674800, NCT03610646.
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