Important Safety Information

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Indication

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 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.

References:
1. Sebag J, Wang M. Combined spectral-domain optical coherence tomography/scanning laser ophthalmoscopy imaging of vitreous and the vitreoretinal interface. In: Holz FG, Spaide RF, eds. Medical Retina: Focus on Retinal Imaging. Berlin, Germany: Springer-Verlag; 2010:157-168. 2. Ponsioen TL, van Luyn MJ, van der Worp RJ, van Meurs JC, Hooymans JM, Los LI. Collagen distribution in the human vitreoretinal interface. Invest Ophthalmol Vis Sci. 2008;49(9):4089-4095. 3. Larsson L, Österlin S. Posterior vitreous detachment. A combined clinical and physiochemical study. Graefes Arch Clin Exp Ophthalmol.1985;223(2):92-95. 4. Meiss R. Sensory physiology. In: Rhoades RA, Tanner GA, eds. Medical Physiology. 1st ed. Boston, MA: Little, Brown and Company; 1995:61–89. 5. Fekrat S, Weizer JS. All About Your Eyes.Durham and London. Duke University Press; 2006:9. 6. Johnson MW. Perifoveal vitreous detachment and its macular complications. Trans Am Ophthalmol Soc. 2005;103:537–567. 7. 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. 8. Smiddy WE, Michels RG, Glaser BM, deBustros S. Vitrectomy for macular traction caused by incomplete vitreous separation. Arch Ophthalmol. 1988;106(5):624–628. 9. Reese AB, Jones IS, Cooper WC. Macular changes secondary to vitreous traction. Trans Am Ophthalmol Soc. 1966;64:123–134. 10. Ezra E. Idiopathic full thickness macular hole: natural history and pathogenesis. 11. Hikichi T, Yoshida A, Trempe CL. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1)55-56. 12. 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. 13. Sonmez K, Capone A Jr, Trese MT, Williams GA. Vitreomacular traction syndrome: impact of anatomical configuration on anatomical and visual outcomes. Retina. 2008;28(9):1207-1214. 14. 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. 15. JETREA [package insert]. Iselin, NJ: ThromboGenics, Inc.; 2017. 16. Ocriplasmin 2nd Periodic Benefit-Risk Evaluation Report. ThromboGenics NV. December 19, 2013. 17. JETREA summary of product characteristics. Iselin, NJ: ThromboGenics, Inc.; 02/2017.

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