OXERVATE

Systemic exposure to cenegermin-bkbj was evaluated by measuring serum nerve growth factor (NGF) concentrations in 20 healthy subjects who received single and multiple (up to six times a day) administration of one drop (35 μL) OXERVATE (0.70 μg of cenegermin-bkbj/administration). The study also included a placebo arm in 10 healthy subjects who received vehicle only. At baseline/pre-dose, 17 out of the 20 subjects in the OXERVATE treatment arm had serum NGF concentrations below the limit of assay ...

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). Th...

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of a...

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Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. ( 5.1 ) 5.1 Use with Contact Lens Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration. 5.2 Eye Discomfort OXERVATE may cause mild ...