The FDA has approved Oxervate for treatment of neurotrophic keratitis

Dompé receives FDA approval cenegermin eye drops, first-in-class recombinant human nerve growth factor with potential to completely heal rare neurotrophic keratitis

Khanna Institute Of Lasik
Khanna Institute Of Lasik
  • cenegermin is the first-ever application of a human nerve growth factor as drug or treatment, and is the first-ever topical biologic medication approved in ophthalmology.
  • The first treatment specifically indicated for neurotrophic keratitis (NK), cenegermin has a mechanism of action that targets the root pathology of the disease.
  • cenegermin was authorized by the European Medicines Agency (EMA) in 2017 and represents Dompé’s first approved therapy in the United States, where it received Orphan Drug Designation, Fast Track Status, and Breakthrough Therapy Designation, which led to Priority Review.

Milan, Italy and San Bruno, California, August 22 2018 – Dompé has announced that the U.S. Food and Drug Administration (FDA) has approved cenegermin, a breakthrough therapy for neurotrophic keratitis (NK), a rare and progressive eye disease that can lead to corneal scarring and vision loss.

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“Neurotrophic keratitis can be disabling, hard to treat, and many patients do not respond well to existing therapies,” – said Reza Dana, Professor of Ophthalmology at Harvard Medical School, Director of the Cornea Service, Senior Scientist at the Massachusetts Eye and Ear, and Dompé medical advisor.“By directly promoting corneal healing, Oxervate has the potential to change the way neurotrophic keratitis is treated, and may eventually result in a new standard of care for patients with this rare condition.”

Neurotrophic keratitis is a rare orphan condition that affects fewer than 65,000 persons in the United States based on estimated disease prevalence.1 It results from impaired function of corneal nerves, which can be caused by herpetic or other infections, ocular surface injuries, ocular or neurologic surgeries, and some systemic conditions that can impair corneal sensation. If unchecked, the disease can progress in severity, leading to persistent epithelial defects, corneal ulcers, melting, perforation and vision loss. Until now, treatment options for neurotrophic keratitis were limited to symptomatic treatments, which do not target the underlying disease pathology. These include artificial tears, antibiotics, autologous serum-derived eye drops, tarsorrhaphy (a procedure in which the eyelids are partially sutured together) and botulinum-induced ptosis (closure of the eyelid). Other surgical interventions, designed to restore the integrity of the cornea, include conjunctival flap surgeries and corneal transplants, which are invasive and can compromise the appearance and function of the eye.1

The drug is based on cenegermin-bkbj, a novel recombinant human nerve growth factor (rhNGF) that is structurally identical to the nerve growth factor (NGF) protein that is made in the human body, including in the ocular tissues. The endogenous protein supports corneal integrity though several mechanisms.2 NGF acts directly on corneal epithelial cells to stimulate their growth and survival. In addition, NGF is known to bind receptors on lacrimal glands to promote tear production, which may provide the eye with lubrication and natural protection from pathogens and injury. The protein also has been shown experimentally to support corneal innervation, which is lost in neurotrophic keratitis.

The regenerative potential of NGF was discovered by Nobel-prize winning scientists3, but its therapeutic potential was not realized in ophthalmology until Dompé’s research and development center in L’Aquila, Italy, created cenegermin-bkbj, a recombinant version of human NGF, through a unique development process. The company’s subsequent trials demonstrated the safety and effectiveness of cenegermin-bkbj for the treatment of neurotrophic keratitis. Oxervate represents the first-ever topical biologic medication approved in ophthalmology, and is the first ever application of a human NGF as drug or treatment.

The FDA has approved Oxervate for treatment of neurotrophic keratitis, a progressive disease affecting the cornea in fewer than five in 10,000 people,.

Oxervate (cenegermin), developed by Dompé farmaceutici SpA, is the first FDA approved drug for the rare disease, which can cause loss of corneal sensation and impair corneal health. Patients with neurotrophic keratitis can experience corneal thinning, ulceration, and perforation in severe cases.

Neurotrophic keratitis has been a “very frustrating disease for physicians,” according to Flavio Mantelli, MD, PhD, chief medical officer for Dompé,. “It was called one of the most challenging conditions to treat. All physicians could do was protect the cornea as much as possible. 

“This approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients,” Wiley Chambers, MD, ophthalmologist at the FDA Center for Drug Evaluation and Research, said in the release.

The safety and efficacy of the topical eye drop was studied in 151 patients with neurotrophic keratitis in two 8-week, randomized, controlled, multi-centre, double-masked studies. In both studies, patients were given the drops six times daily in the affected eyes for 8 weeks. Across both studies, 70% of patients treated with Oxervate experienced complete corneal healing in 8 weeks compared with 28% of patients who were not treated with the active ingredient, cenegermin, according to the release.

Eye pain, ocular hyperemia, eye inflammation and increased lacrimation were the most common adverse events in patients taking the drops.

The definitive results of the studies and the effectiveness of the drug in treating both European and U.S. populations make Oxervate a “breakthrough” for the treatment of neurotrophic keratitis, Mantelli said.

“It’s very important for patients because it changes the natural history of their condition. For the clinicians, it changes the management of their patients from chronic management to an 8-week treatment cycle. It’s quite unique,” he said.

Mantelli noted the drug could be commercialized in the United States by January 2019. – 

 GENERATEDThe FDA has actually approved Oxervate for therapy of neurotrophic keratitis
Dompé obtains FDA authorization cenegermin eye decreases, first-in-class recombinant human nerve development element with prospective to completely recover uncommon neurotrophic keratitis
– cenegermin is the first-ever application of a human nerve development aspect as medication or therapy, and also is the first-ever topical biologic medicine authorized in ophthalmology.
– The first therapy specifically suggested for neurotrophic keratitis (NK), cenegermin has a mechanism of action that targets the root pathology of the condition.
– cenegermin was licensed by the European Medicines Company (EMA) in 2017 and also represents Dompé’s first authorized treatment in the USA, where it received Orphan Medicine Classification, Fast Lane Standing, as well as Innovation Therapy Classification, which led to Priority Evaluation.
Milan, Italy as well as San Bruno, California, August 22 2018– Dompé has actually introduced that the U.S. Fda (FDA) has actually authorized cenegermin, an advancement treatment for neurotrophic keratitis (NK), an unusual as well as progressive eye illness that can lead to corneal scarring and vision loss.
” Neurotrophic keratitis can be disabling, difficult to treat, and numerous people do not react well to existing therapies,”– stated Reza Dana, Professor of Ophthalmology at Harvard Medical College, Supervisor of the Cornea Solution, Senior Citizen Scientist at the Massachusetts Eye as well as Ear, and Dompé medical advisor. “By straight advertising corneal recovery, Oxervate has the possible to transform the method neurotrophic keratitis is dealt with, as well as might at some point result in a new standard of care for people with this rare condition.”
Neurotrophic keratitis is a rare orphan condition that influences less than 65,000 individuals in the United States based on estimated illness frequency.1 It results from impaired function of corneal nerves, which can be caused by herpetic or various other infections, ocular surface injuries, eye or neurologic surgical procedures, and also some systemic conditions that can hinder corneal feeling. If uncontrolled, the illness can progress in severity, bring about persistent epithelial defects, corneal abscess, melting, perforation and vision loss. Until now, treatment alternatives for neurotrophic keratitis were limited to symptomatic therapies, which do not target the underlying illness pathology. These consist of fabricated splits, antibiotics, autologous serum-derived eye declines, tarsorrhaphy (a treatment in which the eyelids are partly sutured with each other) and also botulinum-induced ptosis (closure of the eyelid). Other surgical interventions, developed to recover the honesty of the cornea, include conjunctival flap surgeries and corneal transplants, which are invasive as well as can endanger the appearance and function of the eye.1.
The medication is based on cenegermin-bkbj, an unique recombinant human nerve growth factor (rhNGF) that is structurally identical to the nerve development aspect (NGF) protein that is made in the body, consisting of in the ocular tissues. The endogenous protein supports corneal honesty though several devices.2 NGF acts directly on corneal epithelial cells to stimulate their development and survival. Additionally, NGF is known to bind receptors on lacrimal glands to advertise tear production, which might give the eye with lubrication as well as all-natural defense from microorganisms as well as injury. The healthy protein likewise has actually been shown experimentally to sustain corneal innervation, which is lost in neurotrophic keratitis.
The regenerative potential of NGF was discovered by Nobel-prize winning scientists3, yet its therapeutic possibility was not recognized in ophthalmology until Dompé’s research and development facility in L’Aquila, Italy, created cenegermin-bkbj, a recombinant version of human NGF, with an unique advancement process. The business’s subsequent tests showed the safety and security as well as efficiency of cenegermin-bkbj for the treatment of neurotrophic keratitis. Oxervate represents the first-ever topical biologic medication approved in ophthalmology, as well as is the very first application of a human NGF as medicine or therapy.
The FDA has actually accepted Oxervate for therapy of neurotrophic keratitis, a dynamic illness affecting the cornea in fewer than five in 10,000 people,.
Oxervate (cenegermin), established by Dompé farmaceutici DAY SPA, is the very first FDA authorized medicine for the uncommon condition, which can cause loss of corneal feeling and also impair corneal health. Patients with neurotrophic keratitis can experience corneal thinning, ulcer, as well as perforation in extreme situations.
Neurotrophic keratitis has been a “very aggravating illness for physicians,” according to Flavio Mantelli, MD, PhD, chief clinical officer for Dompé,. “It was called among the most difficult problems to treat. All medical professionals can do was protect the cornea as much as possible.
” This authorization supplies a novel topical therapy and a major advancement that provides total corneal healing for a number of these individuals,” Wiley Chambers, MD, ophthalmologist at the FDA Facility for Medicine Evaluation and Research, said in the launch.
The security and efficacy of the topical eye decline was researched in 151 patients with neurotrophic keratitis in 2 8-week, randomized, managed, multi-centre, double-masked research studies. In both studies, patients were given the declines 6 times daily in the affected eyes for 8 weeks. Throughout both research studies, 70% of patients treated with Oxervate experienced total corneal healing in 8 weeks compared to 28% of individuals who were not treated with the active ingredient, cenegermin, according to the launch.
Eye pain, eye hyperemia, eye inflammation and also enhanced lacrimation were one of the most typical damaging events in people taking the declines.
The definitive outcomes of the studies and also the effectiveness of the medicine in treating both European and U.S. populaces make Oxervate a “breakthrough” for the therapy of neurotrophic keratitis, Mantelli said.
” It’s extremely essential for individuals because it changes the nature of their condition. For the medical professionals, it alters the monitoring of their individuals from persistent administration to an 8-week therapy cycle. It’s fairly special,” he claimed.
Mantelli noted the medication could be marketed in the USA by January 2019.–.

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