Phase I study data offer hope for NK patients

Recombinant human Nerve Growth Factor (rhNGF) may offer hope for patients with neurotrophic keratitis (NK), according to researchers in Milan, Italy, who presented preliminary data from a Phase I study at the annual meeting of the Association for Research in Vision and Ophthalmology. The meeting was held 4–8 May in Orlando, Florida, USA.

The study examined 18 patients (7 men and 11 women) suffering from moderate or severe NK. The patients, who had not responded to currently available medical treatments, were divided into four groups: one group received an eye drop solution of rhNGF for topical use at a dose of 10 µg/mL, another group received an eye drop solution of rhNGF for topical use at a dose of 20 µg/mL, the other two groups received either a simple vehicle or a placebo. The treatments were administered 6 times per day for 8 weeks.

Although the data are still masked, complete resolution of corneal lesions was recorded in the majority of patients, and corneal sensitivity increased in approximately one-third of the patients. Visual analogue scale scores indicated that the treatment was well-tolerated.

rhNGF is now in Phase II development and patient enrolment is under way as part of the REPARO study, which is being performed at 39 centres throughout Europe.

For more information, visit http://clinicaltrials.gov/ct2/show/NCT01756456.