ThromboGenics NV, an integrated biopharma company focused on developing and commercializing innovative ophthalmic and oncology medicines, announced that its partner Alcon has launched JETREA (ocriplasmin) in the UK, its first market in Europe. The first sale of JETREA by Alcon triggers a €45 million milestone payment to ThromboGenics.

ThromboGenics recently received €45 million from Alcon when JETREA gained European approval for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Alcon, a division of Novartis, acquired the rights to commercialize JETREA outside the United States in March 2012. ThromboGenics retains the right to commercialize the drug in the US. ThromboGenics launched JETREA in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA).

JETREA is currently undergoing a single technology appraisal (STA) by the National Institute for Health and Care Excellence (NICE) as part of the process to gain reimbursement when used by the UK National Health Service. The outcome of the STA, in the form of NICE guidance, is expected in the final quarter of 2013.

Dr Patrik De Haes, CEO of ThromboGenics, said, “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 commercialisation 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.”

JETREA contains the active substance ocriplasmin. It is administered through a one-time, single intravitreal injection to treat adults with vitreomacular traction (VMT).

VMT, which in the US is referred to as symptomatic VMA, is an age-related progressive, sight-threatening condition. It is caused by the vitreous humour having an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces.

When the vitreous humour 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 that causes VMT. 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 VMT 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. 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.

ThromboGenics is continuing to work with Alcon, across Europe, to ensure the necessary market access and reimbursement infrastructure in place so that patients can receive JETREA as soon as it is available.