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Aflibercept

Long-Term Efficacy and Safety of Biosimilar CT-P42 in Diabetic Macular Edema

Strategic Insights

— 2 min read

Research findings on the effectiveness of the biosimilar CT-P42 in treating diabetic macular edema have been discussed in a new report. A 24-week phase 3 analysis earlier demonstrated equivalent efficacy and comparable tolerability between CT-P42 and the reference aflibercept in participants with diabetic macular edema. The latest study reports long-term outcomes through week 52.

Key Takeaways:

  • A randomized, double-masked, active-controlled, phase 3 international trial was conducted at 83 study centers across 14 countries, including the Czech Republic, Estonia, Germany, Hungary, India, Latvia, Lithuania, Poland, Republic of Korea, Russia, Slovakia, Spain, and Ukraine.
  • Adults (aged 18 years) diagnosed with type 1 or 2 diabetes mellitus, with diabetic macular edema involving the center of the macula, were randomized (1:1) to receive CT-P42 or reference aflibercept (2 mg in 0.05 mL) by intravitreal injection every 4 weeks (five doses), then every 8 weeks (four doses), over a 52-week study period.
  • The primary efficacy endpoint of mean change from baseline in best corrected visual acuity through week 8 was reported previously, with improvements in best corrected visual acuity maintained throughout and similar between CT-P42 and reference aflibercept, with mean (standard deviation) change from baseline at week 52 of 12.1 (8.9) versus 11.1 (9.9) letters, respectively.
  • Changes from baseline in central subfield thickness and other secondary efficacy endpoints as well as safety endpoints, including treatment-emergent adverse events and immunogenicity, were comparable between groups through week 52.
  • The research concluded that results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity.

Statistics:

  • 306 participants completed the study through week 52, with 153 participants receiving CT-P42 and 153 receiving reference aflibercept.
  • The study was conducted from July 2021 to April 2023.
  • The mean (standard deviation) change from baseline in best corrected visual acuity at week 52 was 12.1 (8.9) for CT-P42 and 11.1 (9.9) for reference aflibercept.

Sources:

  • NewsRx. Research Data from Bern University Hospital Update Understanding of Macular Edema (Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial). Diabetes Week. September 15, 2025; p 694.
  • Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmology and Therapy, 2025.
  • Springer Int Publ Ag, Gewerbestrasse 11, Cham, Ch-6330, Switzerland. (Springer - www.springer.com; Ophthalmology and Therapy - www.springerlink.com/content/2193-6528/)

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