Natalie A. Afshari
SAN FRANCISCO — Oxervate was well-tolerated and effective at reducing corneal lesions among patients with neurotrophic keratopathy, according to a presentation at the American Academy of Ophthalmology annual meeting.
“Neurotrophic keratopathy (NK) is a rare and degenerative disease that can potentially lead to severe ocular complications if not treated appropriately,” Natalie A. Afshari, MD, chief of cornea and refractive surgery at the University of California San Diego’s Shiley Eye Institute, told Ocular Surgery News. “Previously, there were no FDA-approved treatments specifically indicated for NK. Previous treatment options were palliative in nature and posed a high risk of recurrence as they did not address the underlying pathophysiology of the disease.”
Afshari and colleagues conducted the phase 2 study to determine the safety and efficacy of the topical recombinant human nerve growth factor, Oxervate (cenegermin 0.002% ophthalmic solution, Dompé Pharmaceuticals), for the treatment of NK.
The researchers randomly assigned 48 patients to receive six drops of either cenegermin 20 μg/mL or vehicle per day for 8 weeks. All patients were followed for 6 months.
Outcomes assessed included corneal healing, reduction in lesion size over time and rates of disease progression.
Results indicated that cenegermin 0.002% ophthalmic solution induced closure of NK lesions significantly more effectively than vehicle at week 8 (65.2% vs. 16.7%; P < .001). Additionally, patients treated with cenegermin demonstrated statistically significant decreases in overall lesion sizes and rates of disease progression, compared with patients treated with vehicle.
There were no major safety concerns with cenegermin.
“Cenegermin provides a novel, safe and effective treatment option with higher rates of corneal healing compared to vehicle with most adverse effects being reported as mild, and transient,” Afshari said. – by Alaina Tedesco
Reference: Afshari NA. Recombinant human nerve growth factor (cenegermin) for neurotrophic keratitis: A randomized vehicle-controlled trial. Presented at: American Academy of Ophthalmology annual meeting; Oct. 11-15, 2019; San Francisco.
Disclosure: Afshari reports being a consultant for Aescula Tech, Alpine Biotherapeutics, Dompé Pharmaceuticals and Trefoil; owning equity in Aescula Tech, Alpine Biotherapeutics and Trefoil; and receiving financial support from National Eye Institute and Research to Prevent Blindness.