TY - JOUR
T1 - Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration
T2 - A Phase 3 Randomized Trial
AU - Hamouz, Jan
AU - Nowosielska, Agnieszka
AU - Święch-Zubilewicz, Anna
AU - Abengoechea, Santiago
AU - Baumane, Kristine
AU - Vajas, Attila
AU - Siewierska, Małgorzata
AU - Veselovsky, Milan
AU - Veith, Miroslav
AU - Kerényi, Ágnes
AU - Mange, Shobhana
AU - Baidya, Krishnapada
AU - Laganovska, Guna
AU - Jürgens, Ignasi
AU - Papp, András
AU - Gosai, Jignesh
AU - Štefanickova, Jana
AU - Han, Mei
AU - Fryczkowski, Piotr
AU - Zalewski, Dominik
AU - Wang, Jing
AU - Wei, Wenbin
N1 - Publisher Copyright:
© 2024
PY - 2024/10/8
Y1 - 2024/10/8
N2 - OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis®, in patients with neovascular age-related macular degeneration (nAMD).DESIGN: This was a multi-center, double-blinded, randomized controlled phase 3 trial.SUBJECTS, PARTICIPANTS, AND CONTROLS: Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.METHODS, INTERVENTION, OR TESTING: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks.MAIN OUTCOME MEASURES: The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3±9.13 ETDRS letters in the QL1205 group and +7.3±8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.
AB - OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis®, in patients with neovascular age-related macular degeneration (nAMD).DESIGN: This was a multi-center, double-blinded, randomized controlled phase 3 trial.SUBJECTS, PARTICIPANTS, AND CONTROLS: Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.METHODS, INTERVENTION, OR TESTING: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks.MAIN OUTCOME MEASURES: The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49.RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3±9.13 ETDRS letters in the QL1205 group and +7.3±8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.
UR - http://www.scopus.com/inward/record.url?scp=85208349874&partnerID=8YFLogxK
U2 - 10.1016/j.oret.2024.10.001
DO - 10.1016/j.oret.2024.10.001
M3 - Article
C2 - 39389463
SN - 2468-6530
JO - Ophthalmology Retina
JF - Ophthalmology Retina
ER -