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Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase
Sebastian Wolf1, Paulo-Eduardo Stanga2, Milan Veselovsky3
1Department of Ophthalmology, Inselspital, Bern University Hospital, Bern, Switzerland; Department of BioMedical Research, Bern, Switzerland.
Ophthalmology. Retina
|June 28, 2024
Summary
This clinical trial demonstrated that CT-P42 is therapeutically similar to reference aflibercept for treating diabetic macular edema (DME). Both treatments showed comparable efficacy, safety, and pharmacokinetic profiles in patients with DME.
Area of Science:
- Ophthalmology
- Pharmacology
Background:
- Diabetic macular edema (DME) is a leading cause of vision loss in diabetic patients.
- Aflibercept (Eylea) is a standard treatment for DME, but biosimilars offer potential alternatives.
Purpose of the Study:
- To evaluate the therapeutic equivalence of CT-P42 compared to reference aflibercept in adult patients with DME.
- To assess efficacy, pharmacokinetics, usability, safety, and immunogenicity of CT-P42 versus aflibercept.
Main Methods:
- A randomized, active-controlled, double-masked, phase III clinical trial.
- 348 patients with DME were randomized 1:1 to receive either CT-P42 or reference aflibercept via intravitreal injection.
- Primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline to week 8.
Main Results:
- Both CT-P42 and reference aflibercept showed significant BCVA improvement at week 8 (9.43 and 8.85 letters, respectively).
- The treatment difference was within the predefined equivalence margins (95% CI: -0.73 to 1.88; 90% CI: -0.52 to 1.67).
- Efficacy, safety, pharmacokinetics, usability, and immunogenicity were comparable between the two groups through week 24.
Conclusions:
- CT-P42 demonstrated therapeutic equivalence to reference aflibercept in patients with DME.
- The study supports CT-P42 as a viable alternative treatment for diabetic macular edema.
