DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Jetrea(TM) receives positive CHMP opinion
Ocriplasmin is a recombinant truncated form of human plasmin with a molecular weight of 27.2 kD a produced by recombinant DNA technology in a Pichia pastoris expression system.
JETREA is a sterile, clear and colorless solution with no preservatives in a single-use glass vial containing 0.5 mg ocriplasmin in 0.2 mL solution for intravitreal injection after dilution.
Each vial contains 0.5 mg ocriplasmin (active) and 0.21 mg citric acid, 0.75 mg mannitol, sodium hydroxide (for pH adjustment) and water for injection. The pH of the solution is 3.1.
Jetrea(TM) (ocriplasmin),
fri 18 jan 2013
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 ofvitreomacular 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.
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.
New Drug Approvals 