Soon available in Europe after EMA authorisation
La neurotrophic keratitis is a pathology described since the beginning of the century and is characterised by a clinical picture common to all diseases that impair the sensory innervation of the corneaeither by acting on the trigeminal nerve (essential forms, post-surgical injuries, diabetes) than at the level of the tissue fibres (abuse of topical anaesthetics, keratoplasty, burns, post-herpetic, etc.).
In these cases, patients tend to develop epithelial defects recurring that may evolve into acorneal ulcer with little capacity for spontaneous repair and, in the most severe cases, aseptic necrosis and corneal perforation.
In 2015, neurotrophic keratitis was granted 'rare disease' designation by the EMA (European Medicines Agency) (orphan disease), since it has a prevalence in Europe of between 1.6 and 4.2 / 10,000.
To date, no molecule capable of stimulating the reparative process has been available in Europe as an authorised treatment, and neurotrophic keratitis has been managed, depending on the clinical stage, with the frequent application of single-dose artificial tearsadministration of antibiotics in case of bacterial overinfection, the use of protective contact lenses or the use of surgery in extreme cases where the focus was more on saving the integrity of the eyeballwhile sacrificing visual function.
NGF-based drug for corneal ulcers
In June 2017, the EMA authorised the use of an orphan drug based on Nerve Growth Factor (NGF)which will soon be available in Europe for treatment on-label of this rare form of keratitis.
The Nerve Growth Factor is a nerve growth factor discovered in the early 1950s by Prof. Rita Levi Montalcini, who described its trophic and differentiation effects on sympathetic and sensory neurons, and on specific neurons of the central nervous system. In 1996 the Dr Paolo Rama, Director of the Operative Unit of Ophthalmology - Cornea and Ocular Surface at the IRCCS San Raffaele Hospital in Milan, and his team have obtained NGF from Prof. Montalcini's laboratories for ophthalmic trials.
The first case dealt with was that of a 7-year-old girl with a profound stromal ulcer secondary to congenital agenesis of the trigeminal nerve. Dr Rama relates that 'Theulcer corneal healed on the 20th day of treatment, transparency gradually improved, and after a few months the little patient had a completely transparent cornea with excellent vision, which remained stable without the need for further treatment".
Subsequently, more than 100 eyes suffering from neurotrophic ulcers and recovery was achieved in 100% of cases.
The reparative action of NGF is explained by the condition of patients with neurotrophic keratitis who have a lower than normal level of growth factors, which normally stimulate the growth and survival of corneal cells.
Administered as eye drops, NGF helps to restore normal repair mechanisms and promote healing of existing corneal surface damage.
Bibliography
- Lambiase A, Sacchetti M, Bonini S. Nerve growth factor therapy for corneal disease. Curr Opin Ophthalmol. 2012 Jul;23(4):296-302.
- Bonini S, Lambiase A, Rama P, et al. Topical treatment with nerve growth factor for neurotrophic keratitis. Ophthalmology. 2000 Jul;107(7):1347-51; discussion 1351-2.
- Bonini S, Rama P, Olzi D, Lambiase A. Neurotrophic keratitis. Eye 2003, 17(8):989-995.
- Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clinical ophthalmology 2014, 8:571-579.
Dr. Carmelo Chines
Direttore responsabile
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