Jetrea

Generic Name: ocriplasmin
Date of Approval: October 17, 2012
Company: ThromboGenics Inc.

Treatment for: Symptomatic Vitreomacular Adhesion

FDA Approves Jetrea

The U.S. Food and Drug Administration (FDA) has approved Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion, a progressive sight threatening condition. Jetrea is the first pharmacological agent to be approved for this indication.

The approval was based on the data from ThromboGenics’ Phase III program where Jetrea was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01).

Treatment with Jetrea was associated with some, mainly transient, ocular adverse events. The most common side effects reported in patients treated with Jetrea include eye floaters; bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema (swelling); and macular edema.

The recommended dose of Jetrea is 0.125mg (0.1mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. Jetrea is provided as a single use glass vial containing 0.5 mg in 0.2mL solution for intravitreal injection (2.5 mg/mL).

Highlights of Prescribing Information

These highlights do not include all the information needed to use Jetrea safely and effectively. See full prescribing information for Jetrea.

Indications and Usage

Jetrea is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.

Dosage and Administration

  • Must dilute before use.
  • For single use ophthalmic intravitreal injection only.
  • The recommended dose is 0.125 mg (0.1 mL of the diluted solution administered by intravitreal injection to the affected eye once as a single dose.

Dosage Forms and Strengths

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Single-use glass vial containing Jetrea 0.5 mg in 0.2 mL solution for intravitreal injection (2.5 mg/mL).

Contraindications

None.

Warnings and Precautions

  • Decreases in vision due to progression of the condition with traction may occur requiring surgical intervention. Patients should be monitored and instructed to report any symptoms without delay.
  • Intravitreal injection procedure associated effects (intraocular inflammation/infection, intraocular hemorrhage and increased IOP) may occur following an intravitreal injection. Patients should be monitored and instructed to report any symptoms without delay.
  • Potential for lens subluxation.

Jetrea side effects

  • The most commonly reported reactions (≥ 5%) in patients treated with Jetrea were vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, macular hole, reduced visual acuity, visual impairment, and retinal edema.

To report SUSPECTED ADVERSE REACTIONS contact ThromboGenics Inc. at 1-855-253-7396 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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