Cenegermin-bkbj

(Oxervate®)

Cenegermin-bkbj

Drug updated on 9/4/2024

Dosage FormDrops (eye: 0.002% [20 mcg/mL])
Drug ClassRecombinant human nerve growth factors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of neurotrophic keratitis.

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Summary
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  • Oxervate (cenegermin-bkbj) is indicated for the treatment of neurotrophic keratitis.
  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Primary Outcome – Healing of Neurotrophic Lesion: At week 8, 69.6% of cenegermin-treated patients achieved less than 0.5 mm of lesion staining compared to 29.2% of vehicle-treated patients (difference of +40.4%; 95% CI, 14.2%-66.6%; P = 0.006). Additionally, 65.2% of cenegermin-treated patients achieved 0 mm of lesion staining and no other residual staining compared to 16.7% of vehicle-treated patients (difference of +48.6%; 95% CI, 24.0%-73.1%; P < 0.001).
  • Secondary Outcome – Corneal Healing at 4 Weeks: The conservative measure of corneal healing showed statistical significance at week 4, favoring cenegermin over the vehicle.
  • Other Secondary Outcomes: The cenegermin group exhibited statistically significant reductions in lesion size and lower disease progression rates compared to the vehicle group during masked treatment.
  • Cenegermin was well tolerated, with mostly local, mild, and transient adverse effects reported.
  • The study does not specify any significant safety concerns or adverse effects in specific population types or subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Oxervate (cenegermin-bkbj) Prescribing Information.2023Dompé U.S. Inc., Boston, MA

Randomized Controlled Trials