Clinical Efficacy of Eyedrops Containing FGLM–NH2 and IGF–1 for Treatment of Neurotrophic Keratopathy

Abstract

Abstract: : Purpose: We have previously demonstrated the successful treatment in a case of neurotrophic keratopathy with eyedrops containing insulin–like growth factor–1 (IGF–1) and the substance P–derived peptide FGLM–NH₂ .We have now performed an uncontrolled case series study of this treatment in 22 patients with neurotrophic keratopathy. Methods: A total of 22 patients (7 men, 15 women; age range, 27 to 78 years; mean age ± SD, 56.9 ± 13.4 years) with neurotrophic keratopathy was enrolled in the study between January 1997 and December 2003. Fifteen and seven of the subjects manifested persistent epithelial defects (PED) or superficial punctate keratopathy (SPK), respectively. Among the patients with PED, neurotrophic keratopathy was attributable to neurosurgery in five, diabetes in six, keratoplasty in two, and other causes in two; among those with SPK, it was attributable to neurosurgery in five and other causes in two. Administration of eyedrops containing FGLM–NH₂ (1 mg/ml) plus IGF–1 (10 µg/ml) as well as either Levofloxacin or Ofloxacin eyedrops was performed four times a day for 4 weeks. For the PED cases, clinical efficacy was determined from the decrease in the area of fluorescein staining on slitlamp photographs. For SPK cases, clinical efficacy was determined from the decrease in SPK grade as defined by fluorescein staining (Miyata K et al. Arch Ophthalmol. 2003;1537–9). Results: The epithelial defects of nine patients with PED (five due to neurosurgery, three due to diabetes, and one due to other causes) disappeared within 2 weeks of treatment onset. At the end of the 4–week treatment period, the epithelial defects of 11 PED patients had disappeared and those of two had not disappeared; the remaining two PED patients dropped out from the study. SPK improved by two grades or more in three SPK cases due to neurosurgery. No worsening of clinical findings or adverse effects were observed in any of the study subjects. Conclusions: Administration of eyedrops containing FGLM–NH₂ plus IGF–1 is highly effective for the treatment of PED due to neurosurgery in patients with neurotrophic keratopathy. It is also effective for the treatment of PED due to diabetes and of SPK due to neuosurgery in such patients.

Keywords: cornea: clinical science • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • wound healing