Oxervate improved corneal sensitivity, vision in stage 1 neurotrophic keratitis
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SAN DIEGO — Patients with stage 1 neurotrophic keratitis experienced significant improvements in corneal sensitivity and best-corrected visual acuity after an 8-week course of Oxervate, according to a study presented at Academy 2022.
Oxervate (cenegermin-bkbj, Dompé), a recombinant form of human nerve growth factor, was approved by the FDA in 2018 for all stages of neurotrophic keratitis (NK), Whitney Hauser, OD, lead author and Dompé senior director of global medical communications, told Healio
“However, in the pivotal trials conducted in the U.S. and Europe, those patients were stages 2 and 3,” she said. “We thought there was an opportunity to evaluate patients with stage 1 in terms of safety and efficacy.”
Thirty-seven adults (mean age, 64.6 ± 11.9 years; 76% women) in this phase 4, multicenter, open-label prospective study had decreased corneal sensitivity as measured by Cochet-Bonnet esthesiometer and stage 1 NK (per Mackie criteria), Hauser said. They were given one drop of cenegermin-bkbj 20 µg/mL, six times a day for 8 weeks and monitored at 4, 8 and 32 weeks.
Efficacy endpoints included mean change in best-corrected distance visual acuity (BCDVA, logMAR), a 15-letter gain in BCDVA (as per ETDRS) from baseline to week 8 and improvement in corneal sensitivity at weeks 8 and 32.
After 8 weeks of treatment, 91.2% of patients reported improvement in corneal sensitivity (P < .001), which was sustained up to 32 weeks in 82.1% of patients (P < .001), according to the study. In addition, BCDVA statistically and significantly improved from baseline to week 8 (P < .001), and 15.2% of patients gained 15 letters (P < .001).
Eye pain, the most common adverse event, occurred in 37.5% of patients; however, no one discontinued the study because of it.
“At the end of the study, there were found to be significant improvements in corneal sensitivity and BCVA,” Hauser told Healio. “Safety was also evaluated and was very similar to that seen in our pivotal trials. The most common adverse event was eye pain, which was generally mild to moderate and transient.”
She concluded: “Earlier treatment with cenegermin in patients with stage 1 neurotrophic keratitis may be beneficial in preserving vision and improving corneal nerve function, which can be more difficult to achieve in more advanced stages of the disease.”
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Hauser W, et al. A study to evaluate recombinant human nerve growth factor in patients with stage 1 neurotrophic keratitis (DEFENDO). Presented at: Academy; Oct. 26-29, 2022; San Diego.
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