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ThromboGenics Receives Positive CHMP Opinion for JETREA®

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ThromboGenics Receives Positive CHMP Opinion for JETREA®

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ThromboGenics NV has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for JETREA® (ocriplasmin), recommending JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

VMT, in the US referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.

JETREA®, a recombinant form of a human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pulling between vitreous and macula that causes VMT.

By dissolving these proteins, JETREA® releases the traction, and helps to complete the detachment of the vitreous from the macula.

Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012.

ThromboGenics retains the rights to commercialize the drug in the US. In the US, JETREA® has received FDA approval for the treatment of patients with symptomatic vitreomacular adhesion (VMA).

Earlier this week, ThromboGenics introduced JETREA® in the US. The first patients have already received this novel treatment in multiple locations across the country.

“We are very pleased that the CHMP has provided a positive recommendation for JETREA® for the treatment of VMT, including when associated with macular holes,” says Dr Patrik De Haes, CEO of ThromboGenics.

“With our partner Alcon, ThromboGenics, as the marketing authorization holder, will continue to work with the European Medicines Agency and the European Commission as it finalizes the JETREA® European Marketing Authorization Application. Today, more than ever, we are convinced that VMT is an area of unmet medical need. With today’s positive CHMP opinion, we anticipate a final decision by the European Commission within the next 2 to 3 months. The decision will be applicable to all 27 European Union Member states plus Iceland and Norway. Upon the Commission’s final approval and completion of pricing and reimbursement, we intend to support our partner Alcon in making this novel treatment option available to patients in the EU as soon as possible,” De Haes concludes.

JETREA® is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the lightsensitive layer at the back of the eye).

VMT is caused by traction resulting from a persistent attachment of the vitreous (jelly-like material in the center of the eye) to the macula at the back of the eye.

The macula provides central vision that is needed for everyday tasks such as driving, reading and recognizing faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

JETREA® works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT.

Currently the only available treatment in the EU is ‘observation’ or ‘watchful waiting’ until a patient becomes a surgical candidate, usually at a very late stage of the disease.

A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.

“Vitreomacular traction and macular hole formation are disabling eye diseases that influence visual function, and affect activities of patients in their daily life,” said Prof. Dr. Peter Stalmans, Department of Ophthalmology, University Hospitals, Leuven, Belgium.

“When the disease worsens, vitrectomy surgery is the only available treatment option. Release of the vitreous traction by pharmacologic vitreolysis can omit the need for vitrectomy. Upon approval, JETREA® will be the first available product with proven clinical efficacy to release vitreous traction, hence provides a paradigm shifting treatment option for these eye diseases,” he concludes.

Dr. Albert Augustin, Professor of Ophthalmology and Chairman of the Department of Ophthalmology at the Klinikum Karlsruhe, Germany said: “JETREA® represents an important breakthrough for both physicians and patients and is expected to establish a new standard of care for patients with VMT and small macular holes. If approved, a single injection of JETREA® in the affected eye could help to prevent disease progression and/or vision loss.”

For patients with VMT and macular holes, everyday activities, such as reading, driving, the ability to work, use computer screens and overall quality of life are significantly affected," said Professor Yit Yang, Consultant Ophthalmologist, Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK. "I am looking forward to administering JETREA® to patients who I would normally observe till worsening or progression of the disease, as we seek to improve their quality of life.”

The EU MAA submission was based on data from two pivotal Phase III clinical trials that evaluated the safety and efficacy of a single administration of JETREA®.

Both studies met their primary endpoint and demonstrated that JETREA® successfully resolved VMT and macular holes compared to placebo.

At day 28, 26.5% Jetrea-treated patients achieved resolution (versus 10.1% with placebo [P<0.001]). 72% of JETREA® patients who achieved resolution of VMT and macular holes by Day 28, did so within seven days.

All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure.

Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were nonserious, mild in intensity and resolved within 2 to 3 weeks.

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