New drop for neurotrophic keratitis uses human nerve growth factor

October 17, 2019

Historically optometrists have had few options for patients with chronic, neurotrophic corneal defects like nonhealing superficial punctate keratitis (SPK) or sterile corneal ulcers. 

Artificial tears and more recently even amniotic membranes have left many patients still battling chronic ocular surface disease and the vision distortion that accompanies it. 

With a new topical eye drop on the market, optometrists are able to target the underlying concern behind neurotrophic corneal defects: the damaged corneal nerves themselves. 

Apex, NC, optometrist Michael Marino shares his experience as the first optometrist to prescribe Oxervate(cenegermin-bkbj ophthalmic solutionDompé) in North Carolina in this podcast in partnership with Defocus Media. 

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About Oxervate
Oxervate became the first U.S. Food & Drug Administration (FDA)-approved treatment for neurotrophic keratitis in August 2018.1The novel topical eye drop is a recombinant form of human growth factor, the first biologic topical medication approved in ophthalmology and the first FDA-approved use of human nerve growth factor as a drug or treatment. 

The medication was given orphan drug status by the FDA, which fast-tracked its’ approval to be used by both optometrists and ophthalmologists in the United States. 

Candidates for the medication are patients with sterile, neurotrophic corneal defects secondary to damage to any level of the trigeminal nerve (cranial nerve V).

Common causes of impaired corneal sensitivity includeherpetic infections, ocular or neurological surgeries, injuries, or even systemic conditions like diabetes that can impair corneal sensation and the function of the trigeminal nerve.2

The condition is rare, affecting less than 65,000 persons in the U.S.1

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A patient with active herpetic disease should be fully treated first with topical antivirals before treatment for neurotrophic keratitis is initiated. 

Dr. Marino says that his patient had previously had multiple herpes simplex reactivations that had left her cornea neurotrophic. He had been treating a non-healing neurotrophic ulcer for nearly a year before he started her on Oxervate after the corneal defect failed to fully heal even after amniotic membrane treatment. 

Study results
The REPARO (Latin for “repair) clinical trial3established efficacy of treatment in an independent, double-masked, multicenter study of 52 patients with moderate or severe neurotrophic keratitis in Europe. The study compared use of Oxervate monotherapy (20 mcg/mL) in one randomized patient group versus vehicle preservative-free artificial tears in the other patient group. 

After eight weeks, 72 percent of patients in the Oxervate treatment group were completely healed versus only 33.3 percent in the vehicle group. An additional study (NGF0214)4conducted in the U.S. of 48 patients showed similar efficacy, with 65.2 percent of treated patients being completely healed versus only 16.7 percent in the vehicle group. In the European REPARO, approximately 80 percent of patients who healed during the eight-week treatment period remained healed after one year of follow-up. 

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Dr. Marino reports that his patient did not experience significant discomfort using the drop but did report a “tingling sensation” with use. Eye pain or ocular irritations is the most common adverse reaction reported with Oxervate use, with 16 percent of patients in clinical trials experiencing this symptom.3Researchers theorize this side effect is associated with the cornea regaining sensation and can be evidence of a cornea that’s healing. Other less common side effects of drop use were corneal deposits, inflammation, epiphora, and hyperemia.

Prescribing
The process for prescribing the medication can seem daunting at first glance-a quick search on GoodRxputs the out of pocket price at over $12,000 for a full 8-week treatment course. However, the manufacturerhas worked with insurances and patients to offer the medication with little to no out-of-pocket expense.  

Dr. Marino worked with the company’s pharmaceutical reps to get his patient coverage through the Dompé Connect to Care program which helps file insurance and then apply copay cards and a patient assistance program to reduce the financial burden. 

When prescribing the medication, only one pharmacy in the U.S. that provides access to the drop: Accredo Specialty Pharmacy (877-831-8112).

Due to its properties, the medication requires that doctors provide education for patient success. Oxervate is dosed six times per day for eight weeks of treatment, and it arrives stored in glass vials that must be refrigerated before use.  The medication is delivered directly to the patient with weekly shipments of the needed vials. 

To learn more about this medication and how to prescribe it for your patients, listen to this podcast or contact Dr. Michael Marino at drmmarino@trianglevisions.com.

 

References:

1.U.S. Food & Drug Administration. FDA approves first drug for neurotrophic keratitis, a rare eye disease. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-neurotrophic-keratitis-rare-eye-disease. Accessed 10/16/19.

2.Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579.

3. Bonini S, Lambiase A, Rama P, Sinigaglia F, Allegretti M, Chao W, Mantelli F; REPARO Study Group. Phase II Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis. Ophthalmology. 2018 Sep;125(9):1332-1343.

4. Clinicaltrials.gov. Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK. Available at: https://clinicaltrials.gov/ct2/show/results/NCT02227147?view=results. Accessed 10/16/19.