Ophthalmology and therapy · 2026
Safety of GBL1204-An Ophthalmic Bevacizumab in Prefilled Syringe for Neovascular Age-Related Macular Degeneration: A Phase I Study.
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Saraf Amit, Garima Kushal, Dharwadkar Sandhya, Keshav Satish, Patwardhan Sourabh D, Giri Nilesh B, Saxena Moneesh, Phadke Yogesh, Khare Anupriya, Mishra Avain, Kumar Vinod, Singh Sanjay
Аннотация
INTRODUCTION: GBL1204 1.25 mg is an ophthalmic-grade bevacizumab formulation, manufactured in accordance with the stringent ophthalmic quality standards, and supplied in a single-use prefilled syringe (PFS). This clinical trial evaluated the short-term safety and biological activity of a single intravitreal injection of ophthalmic bevacizumab in patients with neovascular age-related macular degeneration (nAMD).
METHODS: This phase I, open-label, single-arm, multicentre trial enrolled 16 participants (aged ≥ 50 years) with best-corrected visual acuity (BCVA) score using Early Treatment of Diabetic Retinopathy Study charts of 20/40-20/320 (approximate Snellen equivalent) at five centres across India. Participants were administered a single intravitreal injection of GBL1204 (1.25 mg/0.05 mL). The main objective was evaluation of ocular and systemic treatment-emergent adverse events (TEAEs), and laboratory parameters over 4 weeks.
RESULTS: GBL1204 complies with the particulate matter standards specified in the United States Pharmacopeia USP < 789 > for ophthalmic injectable solutions. GBL1204 was safe and well tolerated by the patients over 4 weeks. No ocular or systemic serious adverse events occurred. Nine participants (56.25%) reported 14 TEAEs (13 ocular, 1 non-ocular). Of the 14 adverse events, 8 (57.14%) were considered as mild; all adverse events resolved on their own, and without any sequelae. Mean (standard error mean, SEM) BCVA improvement from baseline was + 1.80 (0.76) letters at day 7 and + 3.0 (1.10) letters at day 28. The corresponding mean (SEM) central macular thickness reductions were - 41.67 µm (40.35) and - 64.67 µm (42.74) at days 7 and 28, respectively. Serum vascular endothelial growth factor levels showed expected suppression consistent with bevacizumab pharmacodynamics.
CONCLUSION: A single intravitreal injection of GBL1204 demonstrated favourable short-term safety and tolerability, with evidence of visual and anatomical improvements. These findings support further evaluation of GBL1204 1.25 mg PFS in a pivotal phase III trial as a standardized alternative to compounded bevacizumab. Trial Registration Clinical Trial Registry-India (CTRI): Identification no. CTRI/2024/02/063012.
METHODS: This phase I, open-label, single-arm, multicentre trial enrolled 16 participants (aged ≥ 50 years) with best-corrected visual acuity (BCVA) score using Early Treatment of Diabetic Retinopathy Study charts of 20/40-20/320 (approximate Snellen equivalent) at five centres across India. Participants were administered a single intravitreal injection of GBL1204 (1.25 mg/0.05 mL). The main objective was evaluation of ocular and systemic treatment-emergent adverse events (TEAEs), and laboratory parameters over 4 weeks.
RESULTS: GBL1204 complies with the particulate matter standards specified in the United States Pharmacopeia USP < 789 > for ophthalmic injectable solutions. GBL1204 was safe and well tolerated by the patients over 4 weeks. No ocular or systemic serious adverse events occurred. Nine participants (56.25%) reported 14 TEAEs (13 ocular, 1 non-ocular). Of the 14 adverse events, 8 (57.14%) were considered as mild; all adverse events resolved on their own, and without any sequelae. Mean (standard error mean, SEM) BCVA improvement from baseline was + 1.80 (0.76) letters at day 7 and + 3.0 (1.10) letters at day 28. The corresponding mean (SEM) central macular thickness reductions were - 41.67 µm (40.35) and - 64.67 µm (42.74) at days 7 and 28, respectively. Serum vascular endothelial growth factor levels showed expected suppression consistent with bevacizumab pharmacodynamics.
CONCLUSION: A single intravitreal injection of GBL1204 demonstrated favourable short-term safety and tolerability, with evidence of visual and anatomical improvements. These findings support further evaluation of GBL1204 1.25 mg PFS in a pivotal phase III trial as a standardized alternative to compounded bevacizumab. Trial Registration Clinical Trial Registry-India (CTRI): Identification no. CTRI/2024/02/063012.