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Medications›Dry Eye/OSD›Oxervate

Oxervate®

GoodRx

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

FDA label, Indications and Usage. Pflugfelder SC, et al. Topical Recombinant Human Nerve Growth Factor (Cenegermin) for Neurotrophic Keratopathy: A Multicenter Randomized Vehicle-Controlled Pivotal Trial. Ophthalmology. 2020;127(1):14-26 (epub 2019 Aug 26); Bonini S, et al. Phase II Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis. Ophthalmology. 2018;125(9):1332-1343.

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.

Wirta D, et al. Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial. BMC Ophthalmol. 2024;24(1):290.

Contraindications

Other Dry Eye/OSD drugs

Acetylcysteine
Cequa®
Evoxac®
Eysuvis®
Lacrisert®
Miebo®
Muro 128® 2%
Muro 128® 5%

Browse all medications All Dry Eye/OSD drugs

None listed in the label.

Available Forms

Ophthalmic 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 Action

Recombinant 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 & Lactation

Pregnancy: 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 Use

Safety and effectiveness established in patients 2 years and older.

Oxervate (Cenegermin-bkbj 0.002%) | EyeKnow O.D.