Neurotrophic Keratitis

Following several years of research and innovation, Dompé developed the biotech drug, cenegermin, the first-ever topical medication in the form of eye drops approved for the ophthalmic treatment of neurotrophic keratitis, a rare and progressive eye disease.
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Our eyes are our windows to the world. It is through these windows that we experience life. We often take our eyesight for granted as many of us may never suffer any significant problems with our vision. But for those who suffer from eye disorders that can affect vision, it can be debilitating, especially when that disease has no available treatment. Such has been the case people around the world who suffer from a rare disease called neurotrophic keratitis, which affects up to 5 out of every 10,000 people in the US.​ 

What is Neurotrophic Keratitis?

Neurotrophic keratitis (NK) is a rare degenerative disease affecting the surface of the eye or cornea. The cornea is a highly innervated transparent tissue without any blood vessels, and much of the trophic support for epithelial health and survival comes from its corneal sensory nerves. In patients with NK, these sensory nerves serving the cornea are reduced in number or do not function properly, leading to reduced corneal sensitivity and lack of trophic support to the tissue. Without being able to sense external stimuli such as touch, wind, chemicals, light, heat and cold, the brain does not receive these critical signals to in turn respond with eyelid blinking and reflex tear production, which are protective for the corneal surface. Lack of these protective responses can cause the outer layer of the cornea, the epithelium, to thin and break down and cause an irregular surface distorting light and the tear film. As a result of the parallel lack of trophic support by corneal nerves, a detrimental loop initiates and the epithelial damage can progress to ulceration, corneal melting and perforation.  

 

If left untreated, therefore, the disease can lead to severe complications and vision loss. However, the treatment options for NK were limited to slowing down disease progression rather than addressing the root cause of damage to the cornea. These included lubricating eye drops, protective contact lenses, and in some cases, surgery in the forms of stitching the eyelids shut, and corneal and amniotic membrane transplants. 

 

There was no treatment approved for NK until Dompé developed the first NGF-based drug, cenegermin in the form of eye drops for topical use.  

Neurotrophic Keratitis: a new breakthrough treatment

Following several years of research and innovation, our breakthrough discovery was developing cenegermin into a topical medication in the form of eye drops. This formulation enables patients to easily administer a high drug concentration directly to the damaged corneal epithelium.  

 

Following approval by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), which also granted it Breakthrough Therapy Designation, Fast Track Status, and Priority Review, cenegermin is commercially available in multiple markets worldwide, including those in the European Union and the US. 

 

 Previously, patients who had no options for an FDA-approved treatment, now have hope for alleviation of their symptoms. It’s an achievement that we are very proud of at Dompé. Our indefatigable and talented team is driven by our vision to find cure for patients living with unmet medical needs and to change their lives for the better.   

 

Our success in ophthalmology is only the first step towards NGF-based therapeutic applications. We are committed to continuing to explore the frontiers of NGF, other neurotrophins, as well as researching various delivery systems that may further therapeutic applications for both ophthalmic and non-ophthalmic disease. We know that the full potential of NGF is not yet fully understood, and we look forward to embracing this challenge as we seek to improve patients’ lives globally.