Oxervate (cenegermin-bkbj)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved August 2018

Specific Treatments:

neurotrophic keratitis

Therapeutic Areas

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General Information

Oxervate (cenegermin-bkbj) is a recombinant human nerve growth factor.

Oxervate is specifically indicated for the treatment of neurotrophic keratitis. 

Oxervate is supplied as a solution for topical ophthalmologic administration. Contact lenses should be removed before applying Oxervate and may be reinserted 15 minutes after administration. Instill one drop of Oxervate in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks. If a dose is missed, treatment should be continued as normal, at the next scheduled administration. If more than one topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer Oxervate 15 minutes prior to using any eye ointment, gel or other viscous eye drops.
 

Clinical Results

FDA Approval

The FDA approval of Oxervate was based on two double-masked, randomized, multi-center, controlled clinical trials.Both trials studied Oxervate monotherapy (20 mcg/mL) as compared to vehicle, a proxy for preservative-free artificial tears, among patients with moderate or severe neurotrophic keratitis. Study NGF0212 (REPARO), which was conducted in Europe, randomized 52 patients to each group. After eight weeks, approximately 72% of patients in the treatment group were completely healed. This study had a long-term follow up. In REPARO, approximately 80% of patients who healed during the eight-week treatment period remained healed after one year. Study NGF0214, conducted in the U.S., randomized 24 patients to each group, and 65.2% of treated patients were completely healed after 8 weeks.

 

Side Effects

Adverse effects associated with the use of Oxervate may include, but are not limited to, the following:

eye pain

ocular hyperemia

eye inflammation

increased lacrimation

Mechanism of Action

Oxervate (cenegermin-bkbj) is a recombinant human nerve growth factor. Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.

Additional Information

For additional information regarding neurotrophic keratitis or Oxervate, please visit https://oxervate.com/