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Preliminary data concerning the use of rhNGF in the treatment of neurotrophic keratitis were presented

EuCornea: Dompé wins the “Best Poster Award” for its preliminary data concerning the use of rhNGF in the treatment of neurotrophic keratitis

  • Preliminary data on safety and efficacy of the use of rhNGF (recombinant human Nerve Growth Factor) in the treatment of neurotrophic keratitis were presented at the V Congress of the European Society of Cornea and Ocular Surface Disease Specialists (EuCornea).
  • The poster was selected among about 300 entries on the basis of the value of its content, its scientific quality and innovativeness by a jury whose members included the President and Scientific Board of EuCornea.

Milan, 25 September 2014. Selected among about 300 entries judged by a jury consisting of the President and members of the Scientific Board of the European Society of Cornea and Ocular Surface Disease Specialists (EuCornea), Dompé’s poster concerning the preliminary findings of the REPARO study, Preliminary efficacy evidence of Recombinant Human Nerve Growth Factor eye drops in Neurotrophic Keratitis from a Phase I/II Clinical Trial, received the prestigious “Best Poster Award” at the V EuCornea Congress in London on the basis of its scientific quality, innovativeness, and the value of its contents.

“We are very proud and satisfied to receive this award, which bears witness not only to the quality of our research, but also to the value of our capacity to generate innovation,” declared Eugenio Aringhieri, CEO ofl Dompé Group. “Above all, it is a result that underlines the promise of a research programme that may lead to a therapeutic solution for thousands of patients throughout the world, and will further motivate us to continue our search for ophthalmological innovation on a global scale”.

The poster presented during the EuCornea Congress describes the preliminary results of the Phase I segment of the REPARO Study, a randomized, double-masked, placebo controlled Phase I/II clinical trial. The Phase II segment of the study is currently underway at 39 sites in 9 European countries, and is intended to evaluate the safety, efficacy, and dose-response of treatment with rhNGF eye drops in patients suffering from serious injury and/or corneal ulcers.

Eighteen subjects were involved in the Phase I segment of the study. These subjects were administered either rhNGF in the form of eye drops at two different dosages (10 or 20 µg/ml), or eye drops containing the placebo. Treatment was repeated six times per day for eight weeks. The primary endpoint of the study was the evaluation of safety and tolerability of the treatment, and secondary objectives included corneal wound closure, in addition to the improvement of visual acuity and corneal sensitivity.

The Phase II segment of the REPARO study, currently underway, provides for the recruitment of another 156 patients, divided according to the aforementioned treatment scheme. Currently, the study is in an advanced stage of the enrollment process, with over 90 patients enrolled. The primary endpoint of the trial is to evaluate the complete corneal healing.

Other objectives of the study include assessment of the level of corneal sensitivity, visual acuity, tear function, and efficacy of the treatment over time.

rhNGF recently received the designation of an orphan drug for the treatment of neurotrophic keratitis by the American regulatory agency, the FDA.

It is anticipated that rhNGF will be studied over the next few months for the same pathology in centers of excellence in the treatment of corneal pathologies in the United States.

Although the data is still masked (meaning that it is not yet possible to know which patients received rhNGF and which patients received the placebo), the data from the Phase I segment of the REPARO study show a good safety and tolerability profile among patients affected by neurotrophic keratitis. Administration of rhNGF or the placebo, in fact, did not lead to any significant systemic or ocular side effects.

In 73 percent of patients treated, complete closure of the corneal wound was observed, which in one out of three cases was associated with improvement of the sensitivity of the cornea. It took less time for the corneal wound to heal in the group that was treated with the highest concentration of rhNGF.

Finally, it was confirmed that the patients who showed a progression in the size of the corneal wound, during the Phase I segment as well as during the course of the Phase II segment of the study, had been treated with the placebo. In case of worsening, in fact, data can be unmasked, giving to patients receiving placebo the chance to be treated with rhNGF.

The study demonstrates the safety and tolerability of treatment with rhNGF for ophthalmic use, without significant systemic or ophthalmic complications. The first observations, although they are of a preliminary nature, also provide encouraging indications in terms of efficacy. In order to have reliable data on efficacy, however, it would be necessary to have the full results from the study currently underway, after enrollment has been completed and the data related to the patients treated has been analyzed.