The UK’s National Institute for Health and Care Excellence (NICE) has confirmed its Final Appraisal Determination (FAD) recommendation for ThromboGenics' Jetrea (ocriplasmin) which is an innovative new treatment and should be reimbursed within the National Health Service (NHS) in England and Wales.

The NICE FAD confirms NICE’s earlier Appraisal Consultation Document (ACD), which initially recommended Jetrea as an option for treating vitreomacular traction (VMT) in adults, including when associated with a macular hole of less than or equal to 400 microns, when patients have severe symptoms and an epiretinal membrane is not present.

In its Final Appraisal Determination, NICE for the first time also characterized metamorphopsia as a ‘severe and distressing’ symptom with its impact on the patient being comparable to a loss of two lines in visual acuity.

As a result, NICE not only recommends full reimbursement of Jetrea for patients with VMT and FTMH, smaller or equal to 400 microns, it also recommends reimbursement for those VMT patients with early stage VMT symptoms including metamorphopsia.

There are no other pharmacological treatments in development for the treatment of VMT. Currently patients either have to watch and wait before they are considered eligible for surgery. Surgery is only performed at a later stage of a patient’s disease, once symptoms progress and their sight deteriorates significantly.

Dr Patrik De Haes, CEO of ThromboGenics, said, “This further endorsement from UK NICE is great news for ensuring that physicians, who are treating patients with VMT and macular hole, will have access to Jetrea, the first and only pharmacological treatment for this progressive disease.” Dr Haes further added, “We feel highly encouraged by the NICE FAD confirming that metamorphopsia is a ‘severe and distressing’ symptom that requires immediate treatment, and that an early treatment with Jetrea should be reimbursed by the NHS.”

He informed that there is growing evidence that prolonged VMT may lead to progressive loss of vision and increase a risk that subsequent intervention may be less successful. From our own market research, we also know that a high number of retina specialists feel that patients presenting themselves with metamorphopsia should be treated. With Jetrea, patients, could for the first time, be offered a reimbursed alternative to watchful waiting, meaning they will no longer have to wait until symptoms progress and vision deteriorates. We look forward to final NICE guidance later this year.

Jetrea is the first and only pharmacological treatment indicated for use in patients diagnosed with VMT and macular hole of diameter less than or equal to 400 microns and was approved in the European Union by the European Commission in March 2013. Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States in March 2012. In April, Alcon launched Jetrea in the UK, its first market in Europe, resulting in ThromboGenics receiving €90 million in milestone payments.

The FAD is the last step in the appraisal process before final guidance on the reimbursement of Jetrea is issued to the NHS in England and Wales. Final NICE guidance is expected later this year.

Jetrea contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with vitreomacular traction (VMT).

Jetrea breaks down the protein fibers which cause the abnormal traction between the vitreous and the 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).

The current approach in the EU is ‘observation’, ‘watchful waiting’ or ‘watch and wait’ until a patient becomes a candidate for surgical treatment, 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 closely with Alcon to ensure patients across Europe and rest of the world can access this innovative medicine and receive Jetrea as soon as it becomes available in the respective countries.


ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines.