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If this email does not display correctly, please view online
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| For the treatment of all stages of neurotrophic keratitis (NK)
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NOT JUST ANY SOLUTION
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OXERVATE® is the only FDA-approved treatment option to enable complete corneal healing in most patients with NK.*1-6
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The most common adverse reaction reported in clinical trials (~16%) was eye pain following instillation.1
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*Resolution was evaluated in clinical trials as complete corneal healing, defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment and as lesion staining at 48-week follow-up. 145
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For patients with NK, it's time for Resolutionary Care.
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Visit the improved website to learn how OXERVATE can help you treat patients with NK.
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Important Safety Information
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WARNINGS AND PRECAUTIONS
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Use with Contact Lens
Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin‑bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.
Eye Discomfort
OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.
ADVERSE REACTIONS
In clinical trials, the most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Other adverse reactions occurring in 1% to 10% of OXERVATE patients and more frequently than in the vehicle-treated patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation and tearing.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no data from the use of OXERVATE in pregnant women to inform any drug associated risks.
Lactation
The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for OXERVATE, and any potential adverse effects on the breastfed infant from OXERVATE.
Pediatric Use
The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in pediatric patients 2 years of age and older is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in children.
INDICATION
OXERVATE® (cenegermin‑bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.
DOSAGE AND ADMINISTRATION
Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.
To report ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1‑833‑366‑7387 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for OXERVATE.
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References: 1. OXERVATE® (cenegermin‑bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. Boston, MA; Dompé U.S. Inc.; 2019. 2. Mastropasqua L, Lanzini M, Dua HS, et al. In vivo evaluation of corneal nerves and epithelial healing after treatment with recombinant nerve growth factor for neurotrophic keratopathy. Am J Ophthalmol. 2020;217:278-286. 3. Pedrotti E, Bonacci E, Chierego C, et al. Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy. Orphanet J Rare Dis. 2022;17:1-8. 4. Bonini S, Lambiase A, Rama P, et al. Phase ll randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332-1343. 5. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26. 6. Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the pathogenesis of neurotrophic keratitis: the role of corneal nerves. J Cell Physiol. 2017;232:717-724.
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©2022 Dompé U.S. Inc. All rights reserved.
US-OXE-2200099 12/22
This is a commercial communication developed by Dompé U.S. Inc. ("Dompé").
To unsubscribe please click here. Dompé's business address is: 181 2nd Ave, San Mateo, CA 94401.
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