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Background <p>Dry eye disease (DED) is a multifactorial condition affecting the ocular surface. Recombinant human nerve growth factor (rhNGF) has emerged as a potential new treatment for neurosensory dysfunction. The aim of this study is to evaluate the efficacy and safety of rhNGF in patients with DED.</p> Methods <p>A comprehensive search of six online databases—Medline, CENTRAL, Web of Science, Ovid Medline, ClinicalTrials.gov, and Google Scholar—was conducted to identify randomized controlled trials (RCTs) evaluating the efficacy and safety of rhNGF in patients with dry eye disease, focusing on outcomes such as tear production, ocular surface integrity, and adverse events. </p> Results <p>The results demonstrated that rhNGF significantly improved tear production compared with placebo, as measured by the Schirmer test (MD = 3.84; 95% CI: 2.17–5.51; P &lt; 0.00001; I<sup>2</sup> = 8%). No significant differences were observed in corneal and conjunctival staining (MD = –0.69; 95% CI: –1.62 to 0.25; P = 0.15; I<sup>2</sup> = 0%) or tear breakup time (TBUT) (MD = 0.18; 95% CI: –1.08 to 1.45; P = 0.78; I<sup>2</sup> = 80%). Non-severe adverse events were more frequent with rhNGF, while serious adverse events were similar between groups. Non-severe adverse events were more frequent in the rhNGF group, while the incidence of serious adverse events was comparable to that of the placebo group.</p> Conclusion <p>rhNGF shows promise for improving tear production in patients with dry eye disease, as demonstrated by significant improvement in Schirmer test results. However, evidence for broader clinical efficacy remains limited, with other outcomes showing non-significant or heterogeneous findings. Current data are based on a small number of trials, indicating the need for larger, well-designed studies to clarify the therapeutic role and safety profile of rhNGF in dry eye disease.</p>

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The Efficacy and Safety of Recombinant Human Nerve Growth Factor (rhNGF) in Patients With Dry Eye Disease: A Systematic Review and Meta-analysis

  • 期刊论文

  • 发表日期：

    2026年4月29日

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  • Mohammed F. Qutub,
  • Talal S. Alajmi,
  • Ahmed N. Alnabihi,
  • Anas Alamoudi,
  • Salma H. Almarwani,
  • Suzan E. Ageel,
  • Baraa S. Tabbakh,
  • Lama N. Alghamdi

摘要

Background

Dry eye disease (DED) is a multifactorial condition affecting the ocular surface. Recombinant human nerve growth factor (rhNGF) has emerged as a potential new treatment for neurosensory dysfunction. The aim of this study is to evaluate the efficacy and safety of rhNGF in patients with DED.

Methods

A comprehensive search of six online databases—Medline, CENTRAL, Web of Science, Ovid Medline, ClinicalTrials.gov, and Google Scholar—was conducted to identify randomized controlled trials (RCTs) evaluating the efficacy and safety of rhNGF in patients with dry eye disease, focusing on outcomes such as tear production, ocular surface integrity, and adverse events.

Results

The results demonstrated that rhNGF significantly improved tear production compared with placebo, as measured by the Schirmer test (MD = 3.84; 95% CI: 2.17–5.51; P < 0.00001; I2 = 8%). No significant differences were observed in corneal and conjunctival staining (MD = –0.69; 95% CI: –1.62 to 0.25; P = 0.15; I2 = 0%) or tear breakup time (TBUT) (MD = 0.18; 95% CI: –1.08 to 1.45; P = 0.78; I2 = 80%). Non-severe adverse events were more frequent with rhNGF, while serious adverse events were similar between groups. Non-severe adverse events were more frequent in the rhNGF group, while the incidence of serious adverse events was comparable to that of the placebo group.

Conclusion

rhNGF shows promise for improving tear production in patients with dry eye disease, as demonstrated by significant improvement in Schirmer test results. However, evidence for broader clinical efficacy remains limited, with other outcomes showing non-significant or heterogeneous findings. Current data are based on a small number of trials, indicating the need for larger, well-designed studies to clarify the therapeutic role and safety profile of rhNGF in dry eye disease.