Study shows promise for rare eye condition

Recombinant human nerve growth factor (rhNGF) could provide a targeted treatment for neurotropic keratitis, an untreatable rare eye condition. A Phase I trial of 18 patients – seven men and 11 women – suffering from moderate or severe neurotropic keratitis has demonstrated that rhNGF is well tolerated and that high percentage of patients achieve complete healing of corneal lesions. “These results are of great importance in the course of the clinical development of rhNGF, a candidate drug that originates from the research carried out by Nobel Prize winner Rita Levi Montalcini,” said Eugenio Aringhieri, CEO of Italian Pharmaceutical company Dompé Group. “Our researchers were the first to identify a biotech molecule of NGF for ophthalmic use. The results of this study highlight the potential of NGF in the field of ophthalmology. The patients, who had not responded to currently available medical treatments, were divided into four groups. The first received an eye drop solution for topical use at a dose of 10 µg/ml. In the second group, a simple vehicle was administered. In the third group, a dose of 20 µg/ml was given and, in the fourth group, a placebo was administered. Results showed rhNGF was safe and well tolerated, and in 11 patients there was a notable improvement in corneal conditions. Very little is known about the condition and its causes but it can be associated with diabetes, eye infections caused by the herpes virus, infections, neurosurgical interventions and other related diseases. “Neurotrophic keratitis is characterised by severity and a degenerative course, resulting from reduced innervation of the cornea as a result of various disease states that can even lead to disabling consequences, such as ulceration and perforation of the cornea resulting in loss of visual functions,” said Professor Stefano Bonini, Head of the Department of Ophthalmology at the BioMedico Campus of Rome and Principal Investigator of the study. A Phase II trial is now recruiting at 39 centres in nine countries. There are six centres in the UK including Moorfields Eye Centre.