Global Experience

JETREA®: Up to 28,000 eyes treated and counting1

Starting in 2009, JETREA has been studied in over 1,400 eyes as part of the clinical trial program.

Since the FDA approval in October 2012, JETREA has received approval outside of the United States.

Postmarketing eye exposure based on the total number of vials shipped by distributors. Due to buy-and-bill distribution of JETREA, this number is reflective of vials ordered and not necessarily vials used due to existing inventory that may be in retina specialists' freezers.



Learn About Patient Selection

Patients for JETREA® treatment

Patients who may benefit from JETREA treatment meet the following characteristics.
However, not all patients will respond.

  • Focal adhesion <1500 μm15
  • No epiretinal membrane (ERM).16 ERM is an eye disease that is caused by changes in the vitreous humor.

Focal adhesion size
defined as <1500 μm15

Broad
adhesion15

No epiretinal membrane
(ERM)16

ERM16

Patients with ERM and/or an adhesion >1500 μm may be less likely to have VMA resolution.15,16

JETREA has been shown to be safe and effective in many symptomatic VMA patients.2,3,14

LEARN MORE ABOUT HOW JETREA WORKS

How JETREA® works

  • JETREA is designed to release the attachment between the vitreous and the macula at the back of the eye. This release could help relieve your patients’ symptoms.2
  • These images depict what happens in the back of the eye if treatment with JETREA is successful. Note that in the second image, the attachment has been released.

JETREA mechanism of action

Watch an in-depth overview of the aging eye and learn how JETREA works to help treat symptomatic VMA.

Watch a brief description of the aging eye and learn how JETREA works to help treat symptomatic VMA.

Pivotal Clinical Trials demonstrated significant VMA resolution in 28 days2,3

  • 26.5% of patients treated with JETREA achieved VMA resolution by Day 28
    (vs 10.1% of those treated with vehicle).2,3
  • Of the 123 patients who experienced VMA resolution with JETREA, 70% had resolution by Day 7.1

Post-hoc analysis of patient subgroups in "Oasis", a Two-Year Post-marketing Study, suggested different VMA resolution in 28 days possible in specific patient subgroups17*

Clinical case of symptomatic VMA resolution

  • BASELINE
    BCVA: 20/40
  • DAY 7
    BCVA: 20/80
  • DAY 14
    BCVA: 20/32
  • DAY 28
    BCVA: 20/32
  • MONTH 3
    BCVA: 20/25
  • MONTH 6
    BCVA: 20/32

*These data are from post hoc analyses and were not used for FDA approval.

For the efficacy analysis, subjects were analyzed based on the randomization schedule according to the Intent-to-Treat principle.

Most adverse reactions after JETREA®
injection were transient

What to expect weeks 1 and 2 post injection

STUDY RESULTS: ADVERSE REACTIONS IN THE INJECTED EYE (% OF PATIENTS)1
JETREA (n=465)* Vehicle (n=187)*
Days 0-7 Day 8−End of
Study
Days 0-7 Day 8−End of
Study
Vitreous floaters 13.5 4.1 2.7 5.9
Conjunctival hemorrhage 13.3 1.3 9.6 3.2
Eye pain 10.5 2.8 3.2 2.7
Photopsia 10.1 1.9 1.1 1.6
Blurred vision 6.7 2.2 0.5 3.7
Macular hole 1.1 6.7 0 10.2
Reduced visual acuity 4.1 2.4 0 4.8
Visual impairment 3.4 2.2 0 1.6
Retinal edema 3.7 1.7 0 1.1

The most common adverse reactions in the vehicle-controlled clinical studies were (incidence 5% – 20% listed in descending order of frequency): vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, macular hole, reduced visual acuity, visual impairment, and retinal edema.1

Less common adverse reactions observed in the studies at a frequency of 2% to <5% in patients treated with JETREA® included: macular edema, increased intraocular pressure, anterior chamber cell, photophobia, vitreous detachment, ocular discomfort, iritis, cataract, dry eye, metamorphopsia, conjunctival hyperemia, and retinal degeneration.1

What to expect regarding VA post JETREA® injection

*For the safety analysis, subjects were analyzed according to the actual treatment received. One subject received JETREA instead of the randomly assigned vehicle.

Jetrea Dosing and Administration

Understanding JETREA® dosing and administration

JETREA dosing video


Knowing how to dose and administer JETREA properly is important as it will impact safety and efficacy. Please view this short preparation and administration video featuring step-by-step instructions so you can become comfortable with using JETREA in your patients.

JETREA Preparation and Administration Guide

The JETREA Preparation and Administration Guide is provided in each JETREA shipment box and describes what is in the box, as well as the dosing and administration instructions.

Learn What to Expect Post Injection

What to expect post injection

When you decide to use JETREA®
for your patients, here are
some things to keep in mind
so you know what to expect.

  • Immediately following the intravitreal
    injection, patients should be monitored
    for elevation in intraocular pressure.
  • Following intravitreal injection, patients
    should be instructed to report symptoms
    suggestive of endophthalmitis or retinal detachment
    (eg, eye pain, eye redness, photophobia, blurred or
    decreased vision) without delay.
  • Each vial should only be used to provide a single injection for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used. Treatment with JETREA in the other eye is not recommended within 7 days of the initial injection in order to monitor the post-injection course in the injected eye.
  • Repeated administration of JETREA in the same eye is not recommended.
  • No special dosage modification is required for any of the populations that have been studied (eg, gender, age).
  • Clinical data on the effects of JETREA overdose are limited. If an overdose occurs, close monitoring is recommended. If an adverse reaction occurs, it should be treated according to standard medical practice.
  • JETREA CARE® is a patient assistance program that can help qualified patients obtain financial coverage for JETREA. Over 90% of all patients who apply for the program are approved and will get immediate access to JETREA.1

Educating patients

Because patient experiences with JETREA may vary, it is important to educate patients so they know what to expect.

JETREA procedure

  • JETREA is a one-time, nonsurgical treatment option administered through a single injection into the eye.2

JETREA results

  • Patients who responded to treatment responded by Day 28 with the majority of those patients having results as early as 1 week.3

JETREA safety

JETREA has real-world global clinical experience in treating up to 28,000 eyes and counting.4

Some immediate side effects can include vision changes or eye pain. Other potential side effects may include3,8,9:

  • Floaters
  • Flashes of light
  • Light sensitivity
  • Micropsia

Most side effects occurred within the first week following injection and were transient and mild.14 Patients should report any side effects if they become severe or bothersome.

Learn More about Jetrea Care

Important Safety Information

Click to Expand
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 Health Care Professional.

References:
1. Data on file. ThromboGenics, Inc. 2017. 2. JETREA [package insert]. Iselin, NJ: ThromboGenics, Inc.; 2017. 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;0:1-17.
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. 17. Dugel PU, Tolentino M, Feiner L, Kozma P, Leroy A. Results of the 2-year ocriplasmin for treatment for symptomatic vitreomacular adhesion including macular hole (OASIS) randomized trial. Ophthalmology. 2016;123(10):2232-2247.

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