Drug updated on 9/4/2024
Dosage Form | Drops (eye: 0.002% [20 mcg/mL]) |
Drug Class | Recombinant human nerve growth factors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of neurotrophic keratitis.
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Summary
- 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 Title | Year | Source |
---|---|---|
Oxervate (cenegermin-bkbj) Prescribing Information. | 2023 | Dompé U.S. Inc., Boston, MA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial. | 48Subjects F: 60% M: 40% | 2020 | Ophthalmology |
Sex Distribution:
F:60%
M:40%
48Subjects
Year:
2020
Source:Ophthalmology