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Health Canada Approves ThromboGenics' JETREA® For The Treatment Of Symptomatic Vitreomacular Adhesion

When the vitreous 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. 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 symptomatic VMA has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

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. [ 1 ] , [ 2 ] 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. [ 3 ] , [ 4 ]

ThromboGenics continues to work closely with Alcon to support the regulatory activities and help develop the necessary infrastructure so that patients can access this innovative medicine and receive JETREA ® as soon as it becomes available in the respective countries outside US.

About  JETREA ® (ocriplasmin)

JETREA ®(ocriplasmin) is a truncated form of human plasmin. In the US, JETREA ® is indicated for the treatment of symptomatic VMA. In Europe, JETREA ® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns. JETREA ® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.

JETREA ® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.

JETREA ®'s Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA ® was generally well tolerated with most adverse events being transient and mild in severity.

About ThromboGenics

Stock quotes in this article: THR 

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