Ophthalmics
At Dompé, our R&D strives to address areas of unmet clinical need. This is what led us to discover a treatment for a rare eye disease. Having brought this innovative therapy to eyecare, our research in this therapeutic area continues to expand
Our Contribution to Ophthalmology
Our treatment for Neurotrophic keratitis, a rare degenerative corneal disease, began with our research into Nerve Growth Factor (NGF).
Nerve growth factor (NGF) was discovered by the Italian neurobiologist, Professor Rita Levi-Montalcini, and her colleague biochemist, Dr.Stanley Cohen. In their research, Drs. Levi-Montalcini and Cohen uncovered that NGF plays a crucial role in the proliferation, differentiation and survival of sympathetic and sensory neurons. In 2010 Dompé acquired the rights to produce and market NGF-based treatments.
Following several years of research, our committed team of scientists developed Oxervate® (cenegermin-bkbj) ophthalmic solution, 0.002% (20 mcg/mL), a recombinant human nerve growth factor (rhNGF) indicated for the treatment of neurotrophic keratitis. It is produced using an innovative biotechnological process in which genetic material comprised of sequences coding for NGF is transformed into bacteria.
About Oxervate®
FDA granted cenegermin-bkbj ophthalmic solution “Breakthrough Therapy” designation as well as “Fast Track” and “Priority Review” status; expediting the review and approval of the drug, recognizing neurotrophic keratitis as a serious condition without FDA-approved drug treatments, and the potential for cenegermin-bkbj to fulfill this need, granting approval in 2018.
Our researchers were the first in the world to develop a revolutionary method to enable the production of cenegermin-bkbj. The difficulties of producing and storing the active ingredient and finding the appropriate pharmaceutical formulation for its therapeutic use have long been major obstacles in the development of the commercial manufacture of Oxervate®. Our research has enabled us to overcome these difficulties.
Neurotrophin Research
The field of neurotrophins research is growing and evolving to better understand its pleiotropic effects and mechanisms of action.
At Dompé, we strive to lead the characterization of NGF protein variants, whether naturally acquired or biotechnologically engineered, to deepen our understanding of their effects on neuronal cell types.
Our goal is to identify and produce novel and more effective proteins suitable for drug development. By successfully charting the clinical development path of these molecular entities, we hope to offer our patients options for treatments of diseases for which none exist today.
Our Work in Ophthalmology is Only Just Beginning
Our eyes are one of our smaller organs, but they are fundamental to experiencing our world. Eyesight, which is often taken for granted, may be threatened by ocular diseases that have a lack of approved treatments.We are in the infancy of rhNGF-based applications within ophthalmology; there is much more to investigate. We are researching other possibilities for the use of rhNGF beyond the cornea and are eager to apply the expertise gained through drug development in ophthalmology to other therapeutic areas.
Our overarching focus remains on delivering the therapeutic options to patients who suffer from debilitating diseases that have limited to no approved treatments.
Important Safety Information
Warnings and precautions
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
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.
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 https://www.dompe.com/http://www.fda.gov/medwatch.
References
- 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(4):717-724. doi:10.1002/jcp.25623
- Muller LI, Marfurt CF, Kruse F, Tervo TMT. Corneal nerves: structure, contents and function. Exp Eye Res. 2003;76(5):521-542. doi: 10.1016/s0014-4835(03)00050-2
- Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018:66:107-131. doi: 10.1016/j.preteyeres.2018.04.003
- Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579. doi:10.2 147/0PTH.S45921
- The Nobel Prize in Physiology or Medicine 1986
- Lambiase A, Mantelli F, Sacchetti M, Rossi S, Aloe L, Bonini S. Clinical applications of NGF in ocular diseases. Arch Ital Biol.2011; 149(2):283-292. doi: 10.4449/aib.v 149i2. I 363.
- Lambiase A, Manni L, Bonini S, Rama P, Micera A, Aloe L. Nerve growth factor promotes corneal healing: structural, biochemical, and molecular analyses of rat and human corneas. Invest Ophthalmol Vis Sci. 2000;4 l (5): 1063-1069.
- Louis F. Reichardt Neurotrophin-regulated signalling pathways. Phil. Trans. R. Soc. B (2006) 361, 1545–1564 doi:10.1098/rstb.2006.1894.
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