Oxervate®
Cenegermin-bkbj 0.002% · ophthalmic solution
Dry Eye/OSD
Approved uses
Neurotrophic keratitis
1 drop in the affected eye(s) 6 times daily at 2-hour intervals for 8 weeks
OFF-LABELNot in the FDA label for this product
Moderate-to-severe dry eye disease
1 drop TID x 4 weeks (phase 2 dose-ranging regimen; a BID arm was also studied)
RCT · missed primary endpoint
The phase 2 randomized, double-masked, vehicle-controlled dose-ranging trial (81 TID, 82 BID, 84 vehicle, including Sjogren dry eye) missed its primary endpoint: change in Schirmer I at week 4 did not differ from vehicle (TID difference 0.93 mm, 95% CI -1.47 to 3.32, P=0.078; BID 2.31 mm, 95% CI -0.08 to 4.70, P=0.066, 1-sided alpha 0.025). Symptom scores (SANDE) fell significantly with TID only, and the authors conclude that larger studies are warranted.
Contraindications
None listed in the label.
Available FormsOphthalmic solution 0.002% (20 mcg/mL), weekly carton of 7 multiple-dose 1 mL vials, co-packaged Delivery System Kit with 8 vial adapters, 45 pipettes, 45 sterile disinfectant wipes, 1 dose recording card
Mechanism of ActionRecombinant human nerve growth factor produced in Escherichia coli. Nerve growth factor acts at high-affinity TrkA and low-affinity p75NTR receptors in the anterior segment to support corneal innervation and integrity, the trophic input lost when trigeminal function fails.
Warnings & Precautions
- Eye discomfort: Mild to moderate eye discomfort such as eye pain occurs during treatment; a more serious ocular reaction warrants review.
- Contact lens wear: A therapeutic or corrective lens could theoretically limit distribution to the corneal lesion; remove before dosing and reinsert 15 minutes after.
- Cold chain handling: Stored frozen at the pharmacy and dispensed in an insulated pack; the weekly carton must reach a refrigerator within 5 hours and is good for 14 days refrigerated. Do not refreeze.
Common Side Effects
- Ocular: Eye pain after instillation, about 16%, which may arise as corneal healing occurs.
- Ocular, 1% to 10%: Corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing.
- Systemic: Headache, 1% to 10%.
- Postmarketing: Eye irritation, blepharitis including eyelid margin crusting and eyelid edema, corneal neovascularization.
Pregnancy & LactationPregnancy: No human data. Subcutaneous dosing in pregnant rats and rabbits through organogenesis produced no adverse fetal effects at clinically relevant doses, with a slight increase in post-implantation loss at 42 mcg/kg/day and above (267 times the maximum recommended human ophthalmic dose).
Lactation: No data on presence in human milk, effects on the breastfed infant, or milk production.
Pediatric UseSafety and effectiveness established in patients 2 years and older.