Friday, January 18, 2013

Jetrea(TM) receives positive CHMP opinion, would become the first drug to treat sight-threatening vitreomacular traction and macular hole

Alcon, (a division of Novartis), has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jetrea(TM) (ocriplasmin), 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.  Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient
becomes eligible for surgical intervention at a very late stage of the disease[2],[3] which includes a vitrectomy (removal of the vitreous from the eye) and repair of the retina (innermost layer located in the back of the eye). However, for many patients this is not a suitable option, and damage to the retina may have already occurred.

The EU regulatory 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 hole compared to placebo. 

At day 28, 26.5% of Jetrea-treated patients achieved resolution of VMT (versus 10.1% with placebo [P<0 .001=".001" 28="28" 72="72" achieved="achieved" by="by" day="day" days.="days." did="did" jetrea="jetrea" of="of" patients="patients" resolution="resolution" seven="seven" so="so" span="span" who="who" within="within">
Side effects observed were consistent with the release of traction and intravitreal injections. The most common adverse events with Jetrea in clinical studies (>2%) 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

Separation of the vitreous, a jelly-like substance within the eye, and the macula, the light-sensitive part at the back of the eye responsible for central vision, occurs as part of the natural aging process and is common in people over the age of 50. If the vitreous fails to detach completely, it can place mechanical stress (traction) on the macula, and can even tear the macula, resulting in a macular hole, if not resolved.

Jetrea, a recombinant form of human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pull between vitreous and macula. By dissolving these proteins, Jetrea releases the traction, and helps to complete the detachment of the vitreous from the macula.

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