Cenegermin-bkbj

(Oxervate®)

Cenegermin-bkbj

Drug updated on 5/17/2024

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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  • Cenegermin-bkbj (Oxervate) is indicated for the treatment of neurotrophic keratitis. The drug demonstrated significant efficacy in promoting corneal healing compared to a placebo, with a safety profile characterized by mostly mild and transient adverse effects.
  • The information was derived from a randomized controlled trial.
  • In the study, 69.6% of patients treated with cenegermin showed less than 0.5 mm of lesion staining after eight weeks compared to only 29.2% in the control group; using conservative assessments, these figures were 65.2% versus 16.7%, respectively.
  • Statistically significant differences favoring cenegermin were observed in terms of lesion size reduction and disease progression rates during the masked treatment period. However, specific numbers for secondary outcomes such as changes in visual acuity and corneal sensitivity were not detailed but were implied to favor cenegermin based on context.
  • While direct comparisons regarding safety and effectiveness against other treatments cannot be made from this content alone due to its focus solely on Oxervate's comparison to a placebo rather than other therapeutic agents for neurotrophic keratitis, the study suggests that Oxervate has a favorable risk-benefit profile for individuals needing interventions to promote corneal healing.
  • Although no specific subgroups based on demographics or disease severity are detailed here, broad inclusion criteria suggest potential applicability across diverse patient populations suffering from neurotrophic keratitis. Further research may be necessary to explore efficacy and safety across different subgroups more explicitly.

Product Monograph / Prescribing Information

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

Randomized Controlled Trials