Eye Drug 'Jetrea' Launched by Novartis in the UK
An eye drug Jetrea (ocriplasmin) was launched by Novartis' eye care division, Alcon, in the UK, following approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Jetrea is the only eye drug approved to treat vitreomacular traction (VMT), including when associated with a macular hole of diameter less than or equal to 400 microns.
Jetrea is the first such drug to be released in the European market, which could help treat an estimated 300,000 Europeans who suffer from VMT. Current standard of treatment for VMT in the EU is only 'observation' or 'watchful waiting' followed by surgery at a very late stage of the disease. However, this is not a suitable option for many patients.
VMT is an age-related, progressive and sight-threatening condition, which is caused when the vitreous humor has an abnormally strong attachment to the central part of the retina. This condition may lead to visual distortion, central blindness and decreased visual acuity, if left untreated. Jetrea contains the active substance ocriplasmin, which works by detaching the vitreous humor from the macula. It is administered once through a single intravitreal injection.
"For patients with VMT and macular holes, everyday activities, 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, Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK. "I am looking forward to administering JETREA® to patients who I would normally observe till worsening or progression of the disease, as we seek to improve their quality of life."
The safety and efficacy of Jetrea were evaluated in two pivotal Phase III clinical trials conducted in the U.S. and Europe, comprising 652 patients with vitreomacular adhesion. The study results demonstrated that Jetrea was generally well tolerated and significantly resolved VMT and macular hole, compared to placebo. The most commonly reported adverse reactions were conjunctival hemorrhage, retinal edema, vitreous floaters, photopsia, injection-related eye pain and reduced visual acuity blurred vision.
As part of the licensing deal signed last year, Alcon has acquired rights to market Jetrea outside the US from ThromboGenics, a Belgian biopharmaceutical company, which has developed the drug and has the right to commercialize it in the US. So, the first sale of Jetrea has resulted in a milestone payment of €45 million from Alcon to ThromboGenics.
Dr Patrik De Haes, CEO of ThromboGenics, says: "The launch of JETREA® in Europe by Alcon so shortly after gaining European approval is testimony of our joint commitment to ensuring patients in Europe have access to this innovative drug as soon as possible. The additional €45 million payment from Alcon for reaching this milestone means we are well placed to continue investing in the commercialization of JETREA® in the US via our own commercial organization. We expect that Alcon will roll out JETREA® into other European markets in the coming months and are working with our partner to ensure that all the support for physicians, payers and patients is fully in place."