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Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration
- Source :
- Ophthalmology. 129:54-63
- Publication Year :
- 2022
- Publisher :
- Elsevier BV, 2022.
-
Abstract
- Purpose This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration (nAMD). Design This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study. Participants A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239). Methods Patients received FYB201 or ranibizumab 0.5 mg by intravitreal injection in the study eye every four weeks. Main Outcome Measures The primary end point was change from baseline in best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks prior to the third monthly intravitreal injection. Biosimilarity of FYB201 to its originator was assessed via a two-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters. Results BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was –0.4 ETDRS letters with a 90% confidence interval (CI) of –1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined equivalence margin. Adverse events were comparable between treatment groups. Conclusions FYB201 is biosimilar to reference ranibizumab in terms of clinical efficacy and ocular and systemic safety in the treatment of patients with nAMD.
- Subjects :
- Male
Vascular Endothelial Growth Factor A
genetic structures
Visual Acuity
Angiogenesis Inhibitors
law.invention
0302 clinical medicine
Randomized controlled trial
law
Clinical endpoint
Medicine
Prospective Studies
Fluorescein Angiography
Aged, 80 and over
0303 health sciences
Biosimilar
Diabetic retinopathy
Middle Aged
Treatment Outcome
Lucentis
Choroidal neovascularization
Intravitreal Injections
Female
medicine.symptom
Tomography, Optical Coherence
Neovascular age-related macular degeneration
medicine.drug
medicine.medical_specialty
FYB201
Biological Availability
03 medical and health sciences
Double-Blind Method
Ranibizumab
Settore MED/30
Ophthalmology
Humans
Adverse effect
Biosimilar Pharmaceuticals
Aged
030304 developmental biology
business.industry
Macular degeneration
medicine.disease
Choroidal Neovascularization
Confidence interval
Therapeutic Equivalency
Wet Macular Degeneration
030221 ophthalmology & optometry
sense organs
business
Subjects
Details
- ISSN :
- 01616420
- Volume :
- 129
- Database :
- OpenAIRE
- Journal :
- Ophthalmology
- Accession number :
- edsair.doi.dedup.....159d883edf7f9802be6ad496d74f7206
- Full Text :
- https://doi.org/10.1016/j.ophtha.2021.04.031