Important Safety Information

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Indication

JETREA® (ocriplasmin) Intravitreal Injection, 2.5 mg/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 amplitude decrease).
Adverse Reactions
  • 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 or here if you are a Health Care Professional.

References:
1. Data on file. ThromboGenics, Inc. 2015. 2. JETREA [package insert]. Iselin, NJ: ThromboGenics, Inc.; 2014. 3. Stalmans P, Benz MS, Gandorfer A, et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012;367(7):606-615. 4. Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-1165. 5. Sonmez K, Capone A Jr, Trese MT, et al. Vitreomacular traction syndrome: impact of anatomical configuration on anatomical and visual outcomes. Retina. 2008;28:1207-1214. 6. Hikichi T, Yoshida A, Trempe CL. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61. 7. Stalmans P, Lescrauwaet B, Blot K. A retrospective cohort study in patients with diseases of the vitreomacular interface (ReCoVit). Poster presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting; May 4-8, 2014; Orlando, Florida. 8. Jaffe NS. Vitreous traction at the posterior pole of the fundus due to alterations in the vitreous posterior. Trans Am Acad Ophthalmol Otolaryngol. 1967;71(4):642-652. 9. Smiddy WE, Michels RG, Glaser BM, deBustros S. Vitrectomy for macular traction caused by incomplete vitreous separation. Arch Opthalmol. 1988;106(5):624-628. 10. Metamorphopsia. The Free Dictionary website. Available at: http://medical-dictionary.thefreedictionary.com/metamorphopsia. Accessed on January 21, 2015. 11. Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537-567. 12. American Macular Degeneration Foundation. Examinations. Available at: https://www.macular.org/examinations. Accessed February 13, 2015. 13. Prevent Blindness National. Symptomatic vitreomacular adhesion. Available at http://www.preventblindness.org/symptomatic-vitreomacular-adhesion. Accessed February 13, 2015. 14. Kaiser PK, Kampik A, Kuppermann BD, et al. Safety profile of ocriplasmin for the pharmacologic treatment of symptomatic vitreomacular adhesion/traction. Retina. 2015;35(6):1111-1127. 15. Duker JS, Kaiser PK, Binder S, et al. The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole. Ophthalmology. 2013;120(12):2611-2619. 16. Stalmans P, Duker JS, Kaiser PK, et al. OCT-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis. Retina. 2013;33(10):2003-2011.