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ThromboGenics' JETREA® Granted EU Approval For Vitreomacular Traction (VMT), Including When Associated With Macular Hole Of Diameter Less Than Or Equal To 400 Microns

When the vitreous humour shrinks, the strong attachment results in a pulling force on the retina, which may lead to visual distortion, decreased visual acuity and central blindness. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

JETREA ® breaks down the protein fibers which cause the abnormal traction 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.

JETREA ® can also be used when VMT has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition. [ 1 ]      

Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient becomes a surgical candidate, usually at a late stage of the disease. [ 2 ] , [ 3 ] 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. [ 4 ] , [ 5 ]

ThromboGenics is continuing to work with Alcon, across Europe, to ensure the necessary market access and reimbursement infrastructure in place so that patients can receive JETREA ® as soon as it is available.      

" 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.

" The EU approval of JETREA ®   is a very positive development for patients with VMT and the wider European retina community. This novel pharmacological approach will enable us to improve the treatment of VMT by allowing patients to be treated earlier thereby avoiding the deterioration in their condition that takes place during watchful waiting as well as the risks associated with the surgery. I am looking at quickly integrating the use of  JETREA ®   into my clinical practice as soon as it becomes available."

European MAA

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