JETREA® (ocriplasmin) injection, for Intravitreal Injection, 1.25mg/mL is a proteolytic enzyme
indicated for the treatment of symptomatic vitreomacular adhesion.
Important Safety Information
Warnings and Precautions
- A decrease of ≥ 3 lines of best-corrected visual acuity (BCVA) was experienced by
5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle
in the controlled trials. The majority of these decreases in vision were due to
progression of the condition with traction and many required surgical intervention.
Patients should be monitored appropriately.
- Intravitreal injections are associated with intraocular inflammation/infection,
intraocular hemorrhage and increased intraocular pressure (IOP). Patients should
be monitored and instructed to report any symptoms without delay. In the
controlled trials, intraocular inflammation occurred in 7.1% of patients injected
with JETREA vs 3.7% of patients injected with vehicle. Most of the post-injection
intraocular inflammation events were mild and transient. If the contralateral eye
requires treatment with JETREA, it is not recommended within 7 days of the initial
injection in order to monitor the post-injection course in the injected eye.
- Potential for lens subluxation.
- In the controlled trials, the incidence of retinal detachment was 0.9% in the JETREA
group and 1.6% in the vehicle group, while the incidence of retinal tear (without
detachment) was 1.1% in the JETREA group and 2.7% in the vehicle group. Most of
these events occurred during or after vitrectomy in both groups.
- Dyschromatopsia (generally described as yellowish vision) was reported in 2% of
all patients injected with JETREA. In approximately half of these dyschromatopsia
cases there were also electroretinographic (ERG) changes reported (a- and b-wave
- 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 [OPTION 2] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects of JETREA online directly to ThromboGenics by clicking here if you are a Patient.
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JETREA and the JETREA logo, JETREA CARE and the CARE logo, and THROMBOGENICS and
the THROMBOGENICS logo are trademarks or registered trademarks of ThromboGenics NV.
10/2017 OCRVMA0283 r1