Ophthalmics
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.
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.
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.
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.
In clinical trials, the most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Eye pain may arise as corneal healing occurs. Other adverse reactions occurring in 1% to 10% of OXERVATE® patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.
USE IN SPECIFIC POPULATIONS
There are no data from the use of OXERVATE® in pregnant women to inform any drug associated risks.
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®.
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.
OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.
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®.
References
US-OXE-2300038.1 04/24