Aflibercept 2 mg biosimilar (Tyalia)-real-world experience from IRAN (ATRIA study)
Sahar Avadzadeh1, Ashish Sharma2, Mohammad Mehdi Parvaresh3
1Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Eye (London, England)
|May 3, 2025
Summary
This study found the aflibercept biosimilar Tyalia to be safe and effective in real-world use for retinal conditions. Early results suggest Tyalia offers similar outcomes to the original aflibercept medication.
Area of Science:
- Ophthalmology
- Retinal diseases
- Pharmacology
Background:
- Aflibercept 2 mg is a key treatment for several retinal conditions.
- Evaluating biosimilar efficacy and safety is crucial for clinical adoption.
- Tyalia is an aflibercept biosimilar developed by Cinnagen.
Purpose of the Study:
- To assess the early, real-world clinical outcomes of Tyalia, an aflibercept 2 mg biosimilar.
- To evaluate the safety and efficacy of Tyalia in patients with retinal diseases.
Main Methods:
- A retrospective, uncontrolled observational study.
- Included 148 patients (189 eyes) receiving Tyalia 2 mg intravitreal injections.
- Indications included neovascular age-related macular degeneration (n-AMD), diabetic macular edema (DMO), and retinal vein occlusion (RVO).
Main Results:
- Mean central subfield thickness (CST) improved significantly (p < 0.001).
- Best corrected visual acuity remained stable across the cohort.
- A low rate of adverse events (0.4%) was observed.
Conclusions:
- Preliminary real-world data suggest Tyalia has comparable efficacy and safety to innovator aflibercept 2 mg.
- Further long-term studies with larger populations are required.
- Tyalia shows promise as a safe and effective treatment option for approved indications.
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