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Seeking new horizons

Dompé is currently committed to researching and developing innovative treatment solutions in ophthalmology. This process starts from the study and development of a biotechnological drug based on NGF – the product of the research conducted by Nobel Prize winner Rita Levi Montalcini – as a potential therapeutic response to rare eye diseases, like neurotrophic keratitis and retinitis pigmentosa, and goes on to focus on solutions for the treatment of more common conditions like dry eye.

The journey of a “Nobel prize winning” molecule

In 1986, Rita Levi Montalcini was awarded with the Nobel Prize for Medicine and Physiology, along with her collaborator, US biochemist Stanley Cohen, for the discovery of the Nerve Growth Factor.

Nerve Growth Factor (NGF) is a soluble protein that stimulates the growth, maintenance and survival of neurons. It is part of neurotrophins, a family of proteins that can play a primary role in regulating neuronal survival, development and functions, both at central and peripheral levels. NGF was the first neurotrophic factor to be identified and purified and over the last fifty years its role in neuronal development and its biological activity on neuronal tissues was of great interest to science.

The potentialities of the ophthalmic Nerve Growth Factor initially identified by the groups of Professor Stefano Bonini and Alessandro Lambiase of the Bio-Medical Campus of Rome and Professor Paolo Rama of San Raffaele in Milan have been explored by researchers at Anabasis, an Italian research company Italian who joined Dompé Group, who subsequently developed an ophthalmic formulation of NGF for preclinical and clinical stages of various pathologies affecting both the front of the eye, such as neurotrophic keratitis and dry eye syndrome, and the back, such as pigmentous retinitis and glaucoma.

Dompé's Research&Development path

Dompé's R&D centre in L'Aquila has been set up for the biotechnological production of a drug for clinical use based on recombinant human NGF (rhNGF).

rhNGF: REPARO study in neurotrophic keratitis

Following the encouraging results of the first clinical observations on more than 100 patients with neurotrophic keratitis treated with murine NGF1, Dompé has started clinical trials concerning various ophthalmological disorders.

In the treatment of neurotrophic keratitis, a rare degenerative eye disease for which a treatment is not available, Dompé conducted a study named REPARO. The randomized, double blind, placebo controlled study has involved 37 centres in 9 European countries (Italy, Great Britain, Germany, France, Belgium, Spain, Portugal, Poland, Hungary).

The disease, which in its more severe forms affects less than one person out of 5,000 worldwide2, causes a progressive damage of the cornea, which may even lead to its puncturing and consequent loss of vision. As the cornea is the most innervated organ in the human body, the study aimed at investigating the potential recovery of an adequate nerve response, the positive outcome of which would result in the healing and preservation of the cornea's integrity.

rhNGF:regulatory milestones

In 2015 the European Medicines Agency (EMA) has officially designated recombinant human Nerve Growth Factor (rhNGF) as an orphan drug for the treatment of neurotrophic keratitis. In 2017 Committee for Human Medicinal Products (CHMP) of EMA has released a positive opinion, recommending the marketing authorization for Oxervate® (cenegermin eye drops), for the treatment of adult patients with moderate or severe neurotrophic keratitis.
Read the full EMA press release here.

rhNGF: new scenarios

The dry eye syndrome, which affects the ocular surface, is another condition for which Dompé is evaluating the use of rhNGF through a Phase II study.

The rhNGF development process is not confined to its possible use in the anterior segment of the eye, but also includes disorders that affect the posterior segment. In particular, after rhNGF was designated as an orphan drug in the treatment of retinitis pigmentosa by the FDA and the EMA, a Phase Ib/II multicentre clinical study named LUMOS was started.

Retinis pigmentosa affects on average one person out of 3,500-5,0003, particularly among young adults. In patients suffering from this chronic disease, the photoreceptors (i.e. the retinal cells known as cones and rods, responsible for capturing visual signals) are damaged and subject to progressive degeneration. So far, there are no satisfactory treatments able to slow down its evolution and restore patients' vision.

The possible action of the molecule on the retina opens up new potential for optical nerve diseases, such as glaucoma.


1 Fonti: Bonini S, Lambiase A, Rama P, Caprioglio G, Aloe L., Topical treatment with nerve growth factor for neurotrophic keratitis, Ophthalmology 2000; 107:1347-51
Lambiase A, Rama P, Bonini S, Caprioglio G, Aloe L., Topical treatment with nerve growth factor for neurotrophic corneal ulcers, New Engl J Med 1998; 338:1174-80

2 Fonte: Sacchetti M., Lambiase A., Diagnosis and management of neurotrophic keratitis. Clinical Ophthalmology 2014; 8: 571–579.

3 Fonte: Anasagasti A, Irigoyen C, Barandika O et al., Current mutation discovery approaches in retinitis pigmentosa, Vision Res. 2012; 75: 117-129.