Eyeworld

The first FDA-approved pharmacologic treatment that targets the root pathogenesis of neurotrophic keratitis 1-3 Indication OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. Important Safety Information WARNINGS AND PRECAUTIONS Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. ADVERSE REACTIONS The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, and increase in tears (1%-10% of patients). For additional safety information, see accompanying Brief Summary of Safety Information on the adjacent page and full Prescribing Information on Oxervate.com/HCP. © 2020 Dompé U.S. Inc. All rights reserved. US-OXE-1900180 01/20 • Cenegermin-bkbj, the active ingredient in OXERVATE, is structurally identical to the human nerve growth factor (NGF) protein made in ocular tissues 5 • NGF is an endogenous protein involved in the differentiation and maintenance of neurons, and acts through specific high-affinity (ie, TrkA) and low-affinity (ie, p75NTR) NGF receptors in the anterior segment of the eye to support corneal innervation and integrity. 1 Endogenous NGF is believed to support corneal integrity through 3 primary mechanisms (shown in preclinical models): corneal innervation, reflex tear secretion, and corneal epithelial cell proliferation and differentiation 3,6,7 Explore the breakthrough therapy at Oxervate.com/HCP References: 1. OXERVATE (cenegermin-bkbj) full prescribing information. Dompé. October 2019. 2. FDA approves first drug for neurotrophic keratitis, a rare eye disease [FDA news release]. August 22, 2018. 3. 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. 4. Bonini S, Lambiase A, Rama P, et al. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332- 1343. 5. Voelker R. New drug treats rare, debilitating neurotrophic keratitis. JAMA. 2018;320:1309. 6. Müller LJ, Marfurt CF, Kruse F, Tervo TMT. Corneal nerves: structure, contents and function. Exp Eye Res. 2003;76:521-542. 7. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579. 8. Center for Drug Evaluation and Research, US Food and Drug Administration. Oxervate (cenegermin-bkbj) BLA 761094. Medical Review(s). July 19, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000TOC.cfm. * Complete corneal healing was defined as the absence of staining of the corneal lesion and no persistent staining in the rest of the cornea after 8 weeks of treatment. Based on results from the REPARO trial (Europe, NGF0212; N=156) and the US trial (NGF0214; N=48). 4,8 With OXERVATE, up to 72% of patients achieved complete corneal healing at 8 weeks* 1,4

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