EMA recommends Novartis’ eye drug for approval

Hannah Blake

pharmaphorum

Novartis’ eye care division, Alcon, has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Jetrea (ocriplasmin). Jetrea is a product used for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

VMT is an age-related progressive condition that may lead to visual distortion, decreased visual acuity and central blindness, if left untreated. It is estimated that 250,000 to 300,000 patients in Europe suffer from this sight-threatening condition.

“We are excited to bring this innovative treatment to patients in Europe who live with VMT and macular hole and for whom there has been limited prospect of treatment. This demonstrates Alcon’s steadfast commitment to addressing unmet patient needs in the field of eye care. Europe will be the first region outside the US where we expect Jetrea to be approved and our goal is to make this treatment accessible to many more patients around the world.”

Sabri Markabi, Senior Vice President, Research and Development at Alcon.

At the moment, the only available treatment for VMT in the EU is “observation” or “watchful waiting” until a patient becomes eligible for surgical intervention at a very late stage of the disease. However, this isn’t a viable option for many patients.

“For patients with VMT and macular hole, activities of daily living, such as reading, driving, the ability to work, use computer screens and overall quality of life are 2/3 significantly affected. Jetrea represents an important breakthrough for both patients and retinal specialists and represents a paradigm-shift in this area of retinal therapy and clinical practice.”

Professor Yit Yang, Consultant Ophthalmologist, Royal Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK.

Novartis’ Alcon acquired the rights to commercialise Jetrea outside the United States from the Belgian biopharmaceutical company, ThromboGenics, who retains the rights to commercialise the drug in the US.

In October 2012, Jetrea was approved by the FDA for use in the United States in patients with symptomatic vitreomacular adhesion (VMA), and ThromboGenics launched the product into the market on January 14th 2013.

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Related news:

Novartis wins EU health regulators ok for eye drug Jetrea (Economic Times)

Reference links:

Novartis press release

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