Administered in the form of eye drops to patients with neurotrophic keratitis, cenegermin could promote nerve regeneration, leading to repair the corneal damage.
Two phase II clinical trials involving 204 patients with moderate and severe neurotrophic keratitis showed that after eight weeks a higher number of patients treated with cenegermin reached a complete corneal healing than patients receiving a placebo.
The most common adverse reactions observed with cenegermin include eye pain, eye inflammation, increased lacrimation, eyelid pain, and foreign body sensation in the eye.
Oxervate will be available as a 20 µg/ml eye drops solution.
Dompé is also exploring the use of cenergermin in other optic neuropathies, such as retinitis pigmentosa, glaucoma, dry eye disease, and retinitis pigmentosa.
Meanwhile, researchers at Yamaguchi University and Hiroshima University are pursuing a similar approach to the treatment of neurotrophic keratitis using a combination of the neurotransmitter substance P and insulin-like growth factor 1 (IGF-1).
Researchers elsewhere are investigating extracellular matrix regenerators, sulfate analogs that protect and stabilize the action of such growth factors as FGF-1, FGF-2, TGFbeta-1, and VEGF.
These compounds stimulate the synthesis of collagen and glycosamineglycanes and inhibit the action of enzymes such as elastase, haparanase, or plasmin, all of which enhances the process of extracellular matrix remodeling and regeneration. A phase III multicenter trial of one formulation, Cacicol (Thea) is also underway.
Autologous serum and platelet-rich plasma are also being researched.
Oxervate is Dompé’s first biotechnical drug. “Neurotrophic keratitis is a rare disease that is particularly debilitating, and until now, patients have had no treatment options,” said Eugenio Aringhieri, the company’s chief executive officer. “The European Commission adopted decision is a milestone for patients affected by this disease, for the research in this sector, and for our Company.”
The company will now seek approval for the drug in markets outside Europe, he said.