Phase I trial of recombinant human nerve growth factor for neurotrophic keratitis

2018

OPHTHALMOLOGY

Phase I trial of recombinant human nerve growth factor for neurotrophic keratitis

01 Pubblicazione su rivista

Bonini Stefano, Lambiase Alessandro, Rama Paolo, Filatori Isabella, Allegretti Marcello, Chao Wendy, Mantelli Flavio, Bonini Stefano, Lambiase Alessandro, Rama Paolo, Messmer Elisabeth, Aragona Pasquale, Geerling Gerd, Mastropasqua Leonardo, Mencucci Rita, Dart John, Leonardi Andrea, Montero Jesus, Rolando Maurizio, Reinhard Thomas, Cursiefen Claus, Etxebarria Jaime, Gabison Eric, Szaflik Jacek P., Bouheraoua Nacim, De La Paz Maria, Sainz de la Maza Maite, Wylegala Edward, Figueiredo Francisco, Fogagnolo Paolo, Hossain Parwez, Lorenz Katrin, Robert Pierre-Yves, Benitez del Castillo José, Creuzot-Garcher Catherine, Kruse Friedrich, Malecaze François, Merayo-Lloves Jesús, Rauz Saaeha, Alio Jorge, Carley Fiona, Kanna Ramaesh, Koppen Carina, Nemeth Janos, Murta Joaquim Neto, Torrao Luis

DOI: 10.1016/j.ophtha.2018.03.004

ISSN: 0161-6420

Neurotrophic keratitis/keratopathy (NK), a rare degenerative corneal disease, lacks effective pharmacologic therapies.1 Because NK pathology involves trigeminal nerve damage and loss of corneal innervation, nerve growth factor (NGF) is surmised to promote healing of NK.2 Preliminary studies with murine NGF demonstrated efficacy for treating corneal neurotrophic ulcers;3 however, the complex tertiary structure of NGF has complicated the production of recombinant human NGF (rhNGF) suitable for clinical development. To this end, we developed an Escherichia coli–derived rhNGF formulation that demonstrated to be well tolerated and safe for topical ophthalmic use in a phase I study in healthy volunteers.4 We report phase I results of topical rhNGF for patients with moderate-to-severe NK.

ophathalmology