Alcon Canada Receives Approval for JETREA™ (Ocriplasmin) Solution for Intravitreal Injection, the First and Only Eye Medicine to Treat Sight-Threatening, Symptomatic Vitreomacular Adhesion

• JETREA injection represents a breakthrough for patients with symptomatic vitreomacular adhesion, a progressive eye condition often responsible for retinal distortion, vision deterioration, and irreversible damage and loss of vision^1,2,3,4,5,6
• One-time intravitreal injection of JETREA has shown efficacy in resolution of vitreomacular adhesion, compared to placebo at day 28^1,2

MISSISSAUGA, ON, Aug. 16, 2013 /CNW/ - Alcon, the global leader in eye care and a division of Novartis, today announces the Health Canada approval of JETREA (ocriplasmin) solution for intravitreal injection, for the treatment of symptomatic vitreomacular adhesion.² Vitreomacular adhesion, or VMA, is an age-related, progressive and sight-threatening condition. If left untreated, it can be responsible for retinal distortion, decreased visual acuity, and vision deterioration, with the potential to cause irreversible vision loss or blindness.^3,4,5,6 It is estimated to affect up to 15,000 people in Canada each year.⁷

There is no current pharmacological treatment for patients with symptomatic VMA. The only available approach is “watchful waiting,” meaning patients must undergo a period of observation before they become eligible for eye surgery, known as a vitrectomy. Due to the potential risks and complications, vitrectomy surgery is mostly reserved for patients who are heavily impacted by the symptoms of VMA and are usually in the later stage of the disease, so that lost vision may not be fully recovered.^1,2

“Before JETREA, the only option we had for treating VMA was surgical intervention,” said David Chow, MD, Retina Specialist and Director of the Toronto Retina Institute. “Now with the availability of JETREA, we have a non-surgical option that can be offered during the early stages of VMA, which can make a difference in terms of quality of life for people living with this condition.”

JETREA (ocriplasmin), a recombinant form of human protein (plasmin), works by targeting the protein fibers that cause the abnormal pull between the vitreous and the macula of the eye. By dissolving these proteins, JETREA separates the vitreous from the macula, releasing the vitreomacular adhesion.^2,8 This one-time intravitreal injection has been shown to successfully resolve VMA.^1,2

The Phase III studies, published in the New England Journal of Medicine, showed that patients who were treated with JETREA (ocriplasmin) successfully achieved resolution of VMA as compared to placebo at day 28.¹ By day 28, 26.5% of the patients treated with JETREA achieved resolution of VMA (versus 10.1% with placebo [P<0.001]).¹

“We are very proud to be bringing JETREA to patients in Canada. JETREA is a major breakthrough for people living with VMA and eye care professionals who, until now, have only had surgical options available to treat this debilitating eye disease. Now, they have the option of early treatment with a one-time injection of JETREA, often before their condition deteriorates,” said Alex Long, General Manager of Alcon Canada.

Side effects observed in the Phase III studies of JETREA (ocriplasmin) were consistent with the release of traction and intravitreal injections. The most common Adverse Drug Reactions were consistent with pharmacologic vitreolysis, such as vitreous floaters, photopsia, or were due to inflammation/irritation resulting from either the injection procedure and/or the drug. These were generally considered mild to moderate and were resolved without complications.¹

Alcon acquired the rights to commercialize JETREA injection outside the United States from the Belgian biopharmaceutical company, ThromboGenics, which retains the rights to commercialize the drug in the US. In October 2012, JETREA intravitreal injection was approved in the US for the treatment of patients with symptomatic VMA. European approval for JETREA (ocriplasmin) was granted in March 2013 for the treatment of vitreomacular traction (VMT), including when associated with macular hole equal to or smaller than 400 microns. Healthcare professionals can access more information at www.jetreahcp.com.

About VMA
As people get older, the vitreous (jelly-like material inside the eye that helps maintain the round shape) detaches naturally from the retina (the light-sensitive layer of tissue located at the back of the eyeball).¹³ This detachment is part of the natural aging process and is common over the age of 50.

However, sometimes the vitreous remains attached to some areas of the retina, particularly at the macula, which is the area of the retina responsible for central vision needed for everyday tasks, such as driving, reading and recognizing faces. This is known as vitreomacular adhesion (VMA).¹³

If left unresolved, these areas of VMA can exert a ‘pulling force’ on the macula, a condition referred to as vitreomacular traction (VMT). In some cases, the pulling due to VMT may eventually tear the macula, leading to the formation of a macular hole.^2,13 Symptomatic VMA is a progressive condition that is often responsible for retinal distortion and deterioration in vision, and has the potential to cause irreversible damage and vision loss.^3,4,5,6

About Alcon
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.2 billion in 2012. Headquartered in Fort Worth, Texas, USA, Alcon has more than 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.

JETREA is a trademark of ThromboGenics N.V., licensed to Alcon

References

1. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615
2. Jetrea^® Product Monograph, August 2013
3. Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-1165
4. Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-61
5. Carpineto P,Di Antonio L,Aharrh-Gnama A et al. Diagnosing and Treating Vitreomacular Adhesion. Retina 2011 69-73
6. Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of Opthalmalic and Vision Research. 2012;7(2):148-161
7. Alcon internal estimates/data on file
8. Sebag J. Anomalous posterior vitreous detachment: a unifying concept in vitreo-retinal disease. Graefe’s Arch Clin Exp Ophthalmol. (2004) 242:690-698
9. ICO Guidelines MH 2010/A - ICO International Clinical Guidelines. November 2010
10. Sugiyama A, et al. Reappraisal of spontaneous closure rate of idiopathic full-thickness macular holes. Open Ophthalmol J. 2012;6:73-74
11. Barak Y, Ihnen M, Schaal S. Spectral domain optical coherence tomography in the diagnosis and management of vitreoretinal interface pathologies. J Ophthalmol. 2012.doi:10.1155/2012/876472
12. Gallemore RP, et al. Diagnosis of vitreoretinal adhesions in macular disease with optical coherence tomography. Retina. 2000;20(2): 115-120
13. Dugel P. Retina TodayApril 2012;50
14. Data on file, Summary of Clinical Overview. ThromboGenics Inc, 2012

SOURCE Alcon Canada Inc.