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Alcon and ThromboGenics Announce EU Approval of Pichia-manufactured Jetrea®

3.18.2013

  • One-time intravitreal injection of Jetrea® has shown efficacy in the resolution of VMT and macular hole closure

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. VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss, and is estimated to affect between 250,000 to 300,000 people in Europe alone.

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 U.S. In October 2012, Jetrea® was approved in the U.S. for the treatment of patients with symptomatic vitreomacular adhesion (VMA). On Jan. 14, 2013, ThromboGenics launched Jetrea® in the U.S.

Jetrea® is the trade name for a recombinat form of human protein, made in Pichia,that acts by dissolving the links between the retina and the vitreous, releasing VMT and helping to close macular holes, if present.

“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.”

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.

Side effects observed were consistent with the release of traction and intravitreal injections. The most common adverse events with Jetrea® in clinical studies (>2 percent) 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.

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). 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 (VMA). 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. VMT is often responsible for progressive sight-threatening symptoms and irreversible vision loss.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of $56.7 billion, while R&D throughout the Group amounted to approximately $9.3 billion ($9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit Novartis.com.