The FINANCIAL -- Alcon,
the global leader in eye care and a division of Novartis, announces the
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.
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.
"We are excited to bring this innovative treatment to patients in Europe who live with VMT and macular hole and for whom there has been limited prospect of treatment," said Sabri Markabi, Senior Vice President, Research and Development at Alcon. "This demonstrates Alcon's steadfast commitment to addressing unmet patient needs in the field of eye care. Europe will be the first region outside the US where we expect Jetrea to be approved and our goal is to make this treatment accessible to many more patients around the world."
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, 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.,
"For patients with VMT and macular hole, activities of daily living, 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, Royal Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK. "Jetrea represents an important breakthrough for both patients and retinal specialists and represents a paradigm-shift in this area of retinal therapy and clinical practice."
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. 72% of Jetrea patients who achieved resolution by day 28, did so within seven days.
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.
Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States from the Belgian biopharmaceutical company ThromboGenics, who retains the rights to commercialize the drug in the US. In October 2012, Jetrea was approved in the US for the treatment of patients with symptomatic vitreomacular adhesion (VMA). As Novartis announced, on January 14, 2013, ThromboGenics launched Jetrea in the US.