Oxervate
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Oxervate Prescribing Information
OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.
Ophthalmic solution: cenegermin-bkbj 0.002% (20 mcg/mL) as a clear, colorless solution in a multiple dose vial.
None.
OXERVATE ophthalmic solution contains cenegermin-bkbj, a recombinant form of human nerve growth factor produced in
Cenegermin-bkbj contains 118 amino acids. Cenegermin-bkbj has a relative molecular mass of 13,266 Daltons and the following molecular formula: C583H908N166O173S8. OXERVATE (cenegermin-bkbj) is a clear, colorless sterile solution with a pH of 7.0-7.4 and osmolarity 280-320 mOsm/kg for topical ophthalmic use.
Each mL contains
The efficacy and safety of OXERVATE for the treatment of neurotrophic keratitis was studied in a total of 151 patients, evaluated in two 8-week, randomized, multi-center, double-masked, vehicle-controlled studies. Patients were randomized to OXERVATE, cenegermin-bkbj 10 mcg/mL, or vehicle in Study NGF0212, and OXERVATE or vehicle in Study NGF0214 dosed 6 times daily in the affected eye(s) for 8 weeks. In study NGF0212, only patients with unilateral disease were enrolled, while in study NGF0214 patients with bilateral disease were treated bilaterally. The mean age was 61 to 65 years (18-95). The majority of patients were female (approximately 61%).
Table 1 below summarizes the results for
| Patients without any post-baseline measurements were excluded from the analysis. | |||
| * p-value < 0.01 for both studies. | |||
Study | OXERVATE | Vehicle | Treatment Difference* (95% CI) |
NGF0214 | 15/23 | 4/24 | 48.6% |
NGF0212 | 36/50 | 17/51 | 38.7% |
In patients who were healed after 8 weeks of treatment with OXERVATE, recurrences occurred in approximately 20% of patients in Study NGF0212 and 14% of patients in Study NGF0214.
The results of the mean change from baseline in corneal sensitivity inside the lesion after 8 weeks of treatment are summarized descriptively in Table 2. The mean changes in corneal sensitivity were not clinically significant in either study.
| Change from baseline in corneal sensitivity inside the lesion was analyzed using an analysis of covariance model adjusting for baseline values. Patients without any post-baseline measurements were excluded from the analysis. | ||||
| *Mean (standard deviation) are presented at baseline; least squared means (standard error) are presented at Week 8 | ||||
| ** NGF0214: OXERVATE, n = 21; Vehicle, n = 23 | ||||
| NGF0212: OXERVATE, n = 48; Vehicle, n = 47 | ||||
Study | Visit* | OXERVATE | Vehicle | Treatment Difference** (95% CI) |
NGF0214 | Baseline | 0.8 (1.19) | 0.6 (0.70) | |
Change from baseline at Week 8 | 1.6 (0.26) | 0.7 (0.25) | 0.9 (0.2, 1.7) | |
NGF0212 | Baseline | 1.1 (1.34) | 1.0 (1.19) | |
Change from baseline at Week 8 | 1.1 (0.23) | 0.8 (0.23) | 0.3 (-0.4, 0.9) | |
OXERVATE (cenegermin-bkbj) ophthalmic solution, 0.002% (20 mcg/mL), is a sterile, clear, colorless solution in a multiple-dose vial, closed with a rubber stopper (not made with natural rubber latex), and an aluminum overseal with a polypropylene flip-off cap.
OXERVATE is supplied in weekly cartons containing 7 multiple-dose vials (NDC 71981-020-07). OXERVATE is dispensed to patients in an insulated pack and co-packaged with the Delivery System Kit (NDC 71981-001-01). The Delivery System Kit contains 8 vial adapters, 45 pipettes, 45 sterile disinfectant wipes, and 1 Dose Recording Card.
Store the weekly cartons containing OXERVATE vials in the freezer at or below -4°F (-20°C). Dispense the weekly carton(s) containing OXERVATE vials in an insulated pack in combination with the Delivery System Kit.
Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days. A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature up to 77°F (25°C), for up to 12 hours