Italian biopharmaceutical company Dompé has enrolled the first patient in its Phase I/II REPARO study of recombinant human Nerve Growth Factor (rhNGF), for the treatment of neurotrophic keratitis (NK).
The international clinical trial is the first to evaluate the ophthalmological use of a topical solution of rhNGF to treat moderate-to-severe NK.
Dompé Group CEO Eugenio Aringhieri said the trial will pave the way for the development of a new drug for the treatment of severe neurotrophic keratitis.
"We believe that the results of the trial will allow us to offer a proven therapy to patients throughout the world, who run the risk of losing their eyesight due to the lack of effective treatment options and, more generally, will further clarify the potential use of NGF in ophthalmology," Aringhieri said.
The randomised, double-masked, placebo-controlled trial is designed to enrol patients across nine countries with grade 2 or grade 3 lesions NK, and who failed to respond to existing medications.
Around 174 patients are expected to be randomised with one of the two doses or placebo during the eight week controlled treatment period, with a follow-up for at least 48 weeks.
Evaluation of the safety and efficacy of two doses of a rhNGF (10 µg/ml and 20 µg/ml) solution administered topically in the form of eye drops, is the primary objective of the trial.
The duration of corneal healing, improvement in visual acuity and corneal sensitivity are the secondary objectives.
Campus BioMedico, Rome, ophthalmology department director Professor Stefano Bonini said; "Neurotrophic keratitis is a severe degenerative eye disease caused by reduced corneal innervation that can lead to the ulceration and perforation of the cornea, and a consequent loss of visual function."