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DompA(c) Receives FDA Approval of Oxervate Eye Drops with Potential to Heal Rare Neurotrophic Keratitis.

M2 PHARMA-August 27, 2018-DompA(c) Receives FDA Approval of Oxervate Eye Drops with Potential to Heal Rare Neurotrophic Keratitis


- The US Food and Drug Administration has approved Oxervate (cenegermin-bkbj ophthalmic solution), a breakthrough therapy for neurotrophic keratitis, a rare and progressive eye disease that can lead to corneal scarring and vision loss, Italy-based Dompe said.

Neurotrophic keratitis is a rare orphan condition that affects fewer than 65,000 persons in the United States based on estimated disease prevalence.

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.

Oxervate is based on cenegermin-bkbj, a novel recombinant human nerve growth factor (rhNGF) that is structurally identical to the nerve growth factor protein that is made in the human body, including in the ocular tissues.

The endogenous protein supports corneal integrity though several mechanisms.

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 scientists, but its therapeutic potential was not realized in ophthalmology until Dompe'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.

Oxervate is approved for use in adults and in children 2 years of age and older. Oxervate is taken over an eight-week period in which patients can easily self-administer the treatment at home. Investigated as a monotherapy, Oxervate offers patients a treatment option that could prevent the need for invasive procedures.

Oxervate will be made available by Dompe in the United States by early 2019. Details regarding patient access will be announced prior to that time.

Dompe is a private biopharmaceutical company founded in Milan, Italy.

Currently, Dompe employs 700 employees worldwide and is growing in the United States, Spain, Germany and France.

In the United States, the commercial operations hub is located in the San Francisco Bay Area and the company maintains an R and D presence in Boston.

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Publication:M2 Pharma
Date:Aug 27, 2018
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