Investigative Ophthalmology & Visual Science Cover Image for Volume 65, Issue 7
June 2024
Volume 65, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2024
Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42
Author Affiliations & Notes
  • Paulo-Eduardo Stanga
    Stanga Ltd, London, United Kingdom
    University College London, London, United Kingdom
  • Sebastian Wolf
    Inselspital Universitatsspital Bern, Bern, Bern, Switzerland
  • Milan Veselovsky
    Ophthalmology, University Hospital and Clinic, Zilina, Zilina, Slovakia
  • Miroslav Veith
    Fakultni nemocnice Kralovske Vinohrady, Praha, Praha, Czechia
  • Andras Papp
    Semmelweis Egyetem, Budapest, Budapest, Hungary
  • Shobhana Mange
    Shivam Retina Clinic and Eye Hospital, India
  • Lakshikanta Mondal
    Regional Institute of Ophthalmology Kolkata, Kolkata, West Bengal, India
  • Sunghyun Kim
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • Keumyoung Ahn
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • Suyoung Kim
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • Dain Son
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • Hyejin Kang
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • Hyunjin Lee
    Celltrion Healthcare Co Ltd, Incheon, Incheon, Korea (the Republic of)
  • David M Brown
    Retina Consultants of Texas, Houston, Texas, United States
  • Footnotes
    Commercial Relationships   Paulo-Eduardo Stanga celltrion, Code C (Consultant/Contractor); Sebastian Wolf celltrion, Code C (Consultant/Contractor); Milan Veselovsky Celltrion, Code C (Consultant/Contractor); Miroslav Veith celltrion, Code C (Consultant/Contractor); Andras Papp celltrion, Code C (Consultant/Contractor); Shobhana Mange Celltrion, Code C (Consultant/Contractor); Lakshikanta Mondal Celltrion, Code C (Consultant/Contractor); Sunghyun Kim Celltrion, Code E (Employment); Keumyoung Ahn Celltrion, Code E (Employment); Suyoung Kim Celltrion, Code E (Employment); Dain Son Celltrion, Code E (Employment); Hyejin Kang Celltrion, Code E (Employment); Hyunjin Lee Celltrion, Code E (Employment); David Brown celltrion, Code C (Consultant/Contractor)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2024, Vol.65, 4907. doi:
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      Paulo-Eduardo Stanga, Sebastian Wolf, Milan Veselovsky, Miroslav Veith, Andras Papp, Shobhana Mange, Lakshikanta Mondal, Sunghyun Kim, Keumyoung Ahn, Suyoung Kim, Dain Son, Hyejin Kang, Hyunjin Lee, David M Brown; Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42. Invest. Ophthalmol. Vis. Sci. 2024;65(7):4907.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : CT-P42 is a proposed biosimilar to reference aflibercept (AFL). Therapeutic equivalence from phase III study (NCT04739306) in DME has been reported previously. The objective of this report is to evaluate the long-term efficacy, safety and immunogenicity up to 52 weeks.

Methods : CT-P42 3.1 is a randomized, double-masked, active-controlled Phase 3 Study designed to evaluate the efficacy, Pharmacokinetics (PK), usability, and overall safety including immunogenicity of CT-P42 and AFL via intravitreal (IVT) injection using a single-dose vial kit. Patients with DME, who had central subfield retinal thickness of ≥350 μm, Best Corrected Visual Acuity (BCVA) score of 73 to 34 letters in the study eye, were randomly assigned in a 1:1 ratio to receive 2mg/0.05 mL of CT-P42 or AFL every 4 weeks (5 doses) then every 8 weeks (4 doses) up to 52 weeks.

Results : A total of 348 patients were randomized (CT-P42:173, AFL:175) and 306 patients completed (CT-P42:153, AFL:153) the study up to 52 Weeks. Sustained and comparable efficacy maintained through Week 52 in terms of mean change from the baseline in BCVA and central subfield thickness (CST) (Figure 1). Mean change in BCVA from baseline was gradually increased at all following visits through Week 16 and maintained up to Week 52 in both treatment groups. The similarity was supported by change from baseline in CST through Week 52. Other secondary efficacy endpoints were generally similar between the treatment groups up to Week 52. No clinically meaningful difference was observed in treatment-emergent adverse events (TEAEs) (CT-P42:109 [62.6%], AFL 117 [67.2%] patients) and ocular TEAEs in the study eye (CT-P42: 31 [17.8%], AFL 38 [21.8%] patients) up to Week 52 (Table 1). The proportions of patients who had at least one ADA positive results were 3 (1.7%) patients in CT-P42 group, 4 (2.3%) patients in AFL group up to Week 52. Overall, CT-P42 demonstrated a well-tolerated safety profile which was similar to that of AFL.

Conclusions : This result supported the therapeutic equivalence between CT-P42 and AFL by demonstrating comparable efficacy and safety of CT-P42 compared to Eylea based on the 52-week data.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

 

 

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