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Introduction <p>GBL1204 1.25&#xa0;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).</p> Methods <p>This phase&#xa0;I, open-label, single-arm, multicentre trial enrolled 16 participants (aged ≥ 50&#xa0;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&#xa0;mg/0.05&#xa0;mL). The main objective was evaluation of ocular and systemic treatment-emergent adverse events (TEAEs), and laboratory parameters over 4&#xa0;weeks.</p> Results <p>GBL1204 complies with the particulate matter standards specified in the United States Pharmacopeia USP &lt; 789 &gt; for ophthalmic injectable solutions. GBL1204 was safe and well tolerated by the patients over 4&#xa0;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&#xa0;7 and + 3.0 (1.10) letters at day&#xa0;28. The corresponding mean (SEM) central macular thickness reductions were − 41.67&#xa0;µm (40.35) and − 64.67&#xa0;µm (42.74) at days&#xa0;7 and 28, respectively. Serum vascular endothelial growth factor levels showed expected suppression consistent with bevacizumab pharmacodynamics.</p> Conclusion <p>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&#xa0;mg PFS in a pivotal phase&#xa0;III trial as a standardized alternative to compounded bevacizumab.</p> <p><b>Trial Registration</b> Clinical Trial Registry—India (CTRI): Identification no. CTRI/2024/02/063012.</p>

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Safety of GBL1204—An Ophthalmic Bevacizumab in Prefilled Syringe for Neovascular Age-Related Macular Degeneration: A Phase I Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月3日

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  • Amit Saraf,
  • Kushal Garima,
  • Sandhya Dharwadkar,
  • Satish Keshav,
  • Sourabh D. Patwardhan,
  • Nilesh B. Giri,
  • Moneesh Saxena,
  • Yogesh Phadke,
  • Anupriya Khare,
  • Avain Mishra,
  • Vinod Kumar,
  • Sanjay Singh

摘要

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.