Alcon announces EU approval of Jetrea®

Alcon, the global leader in eye care and a division of Novartis, announces that the European Commission has approved Jetrea®intravitreal injection (ocriplasmin) in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.[2] VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss,[3],[4],[5],[6] and is estimated to affect between 250,000 to 300,000 people in Europe alone.[7]

“The approval of Jetrea by the European Commission is a major breakthrough for people with VMT and eye care professionals who, until now, have only had surgical options available to treat this debilitating eye disease. Now they can intervene early with a one-time injection of Jetrea,” said Stuart Raetzman, Area President Europe, Middle East and Africa at Alcon. “Jetrea meets a genuine unmet patient need and demonstrates Alcon’s commitment to bringing innovative eye care treatments to people in Europe and throughout the world.”

The pivotal studies, published in the New England Journal of Medicine, showed that patients who were treated with Jetrea successfully achieved resolution of VMT and closure of macular holes as compared to placebo at day 28.[1] By day 28, 26.5% of the patients treated with Jetrea achieved resolution of VMT (versus 10.1% with placebo [P<0.001]).[1] In addition, 40.6% of the patients treated with Jetrea achieved closure of a macular hole by day 28 (versus 10.6% with placebo [P<0.001]).[1]

Jetrea, a recombinant form of human protein (plasmin), targets the protein fibers which cause the abnormal pull between the vitreous and the macula. By dissolving these proteins, Jetrea separates the vitreous from the macula, releasing VMT and helping to close the macular hole (if present).[2],[8] This one-time injection has been shown to provide early resolution of VMT, including when associated with macular hole of diameter less than or equal to 400 microns.[1],[2]

Side effects observed were consistent with the release of traction and intravitreal injections. The most common adverse events with Jetrea in clinical studies (>2%) included: vitreous floaters, photopsia, conjunctival hemorrhage, injection-related eye pain, blurred vision, reduced visual acuity, and retinal edema. These were generally considered mild to moderate and were resolved without complications.[1]

Alcon, a division of Novartis, acquired the rights to commercialize Jetrea 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 was approved in the US for the treatment of patients with symptomatic vitreomacular adhesion (VMA). On January 14, 2013, ThromboGenics launched Jetrea in the US.

About VMT including macular hole

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).[9] However, with some people, the vitreous remains attached to areas of the retina, particularly at the macula (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.[9]These areas of vitreomacular adhesion can exert a ‘pulling force’ on the macula, a condition known as vitreomacular traction (VMT). VMT may eventually lead to the formation of a hole in the macula.[2],[9] VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss.[3],[4],[5],[6]

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® Summary of Product Characteristics. ThromboGenics NV. Belgium
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
8. Data on file, Summary of Clinical Overview. ThromboGenics Inc, 2012
9. Dugel P. Retina Today April 2012;50