Aflibercept Biosimilar MYL-1701P Shows Equivalence in Diabetic Macular Edema Trial
核心洞察
MYL-1701P, a biosimilar for aflibercept, demonstrated clinical equivalence in efficacy, safety, and immunogenicity in treating diabetic macular edema (搜索) (DME).
The INSIGHT trial, involving 77 clinical centers across 9 countries, compared MYL-1701P to reference aflibercept over a 52-week period.
Results showed comparable improvements in Best Corrected Visual Acuity (BCVA) and Central Subfield Thickness (CST) between the biosimilar and reference product.
The biosimilar aflibercept MYL-1701P has demonstrated clinical equivalence to reference aflibercept (Eylea; Regeneron Pharmaceuticals Inc (搜索)) in treating diabetic macular edema (搜索) (DME), according to results from the INSIGHT trial (NCT03610646). This supports its potential use as an alternative treatment option. The study, published in JAMA Ophthalmology, highlights the 1-year outcomes of the biosimilar compared to the reference product for DME.
The INSIGHT trial, conducted across 77 clinical centers in 9 countries between August 2018 and September 2021, included patients 18 years and older diagnosed with type 1 or type 2 diabetes and central DME, who had not previously undergone anti-vascular endothelial growth factor therapy. A total of 639 individuals were screened, with 324 randomized to receive either 2 mg of MYL-1701P or the reference product via intravitreal injection. The treatment regimen involved injections every 4 weeks through 16 weeks, followed by every 8 weeks through week 48, with additional doses administered based on pre-specified BCVA and CST criteria.
The primary outcome was the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 8. Secondary endpoints included the mean change in Central Subfield Thickness (CST) from baseline at week 8, the cumulative number of study drug injections administered during the 48-week treatment period, and the proportion of individuals gaining 15 letters or more from baseline.
Efficacy and Safety Outcomes
At week 8, the mean change in BCVA was 6.60 letters for the MYL-1701P group and 6.56 letters for the reference product group, meeting the primary outcome. The mean change in CST was -112 and -124, respectively. Adjusted mean changes for both BCVA and CST were comparable between the two groups. At week 52, the proportion of individuals gaining 15 letters or more from baseline was also similar between the groups.
The mean number of injections through week 48 was 8.4 for MYL-1701P and 8.7 for the reference product. The incidence of non-ocular treatment-emergent adverse events through week 52 was similar at 65.2% and 65.3%, respectively. Three serious non-ocular events (embolic stroke, cardiac arrest, and brain stem infarction) were reported as potentially drug-related.
Regulatory Approval and Clinical Significance
In May 2024, the FDA approved the first biosimilars for aflibercept, including aflibercept-jbvf (Yesafili, known as MYL-1701P; Biocon Biologics (搜索)) and aflibercept-yszy (Opuviz; Biogen, Samsung Bioepis), both with interchangeability status. MYL-1701P is indicated for neovascular age-related macular degeneration (搜索) and diabetic macular edema (搜索) (DME).
The INSIGHT trial is the first to compare the biosimilar with the reference product for DME. According to the study authors, reference aflibercept has shown more effectiveness for DME compared with ranibizumab and repackaged bevacizumab.