ThromboGenics NV has announced that the U.S. Food and Drug Administration (FDA) has approved JETREA® (ocriplasmin) in the USA for the treatment of symptomatic VMA, a progressive sight threatening condition. JETREA® is the first pharmacological agent to be approved for this indication.
The recommended dose of JETREA® is 0.125mg (0.1mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection.
JETREA® is provided as a single use glass vial containing 0.5 mg in 0.2mL solution for intravitreal injection (2.5 mg/mL).
Dr Patrik De Haes, CEO of ThromboGenics, said: “Today’s FDA approval of JETREA® is a major milestone for the Company. We are extremely pleased that we will be able to meet a major unmet clinical need in ophthalmology when we make JETREA®, the first pharmacological agent for symptomatic VMA, available to the many thousands of U.S. patients who could benefit from treatment of this progressive, sight-threatening condition. We are continuing to prepare for the planned launch of JETREA® in January 2013 through our own U.S. commercial organization. This is the biggest step in transforming ThromboGenics into a profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines.”
The approval was based on the data from ThromboGenics’ Phase III program where JETREA® was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with JETREA® was associated with some, mainly transient, ocular adverse events.
Important safety and prescribing information about JETREA® is now available at www.jetrea.com.
Prof. Désiré Collen, ThromboGenics’ Chairman, said: “Just over a decade ago research with autologous plasmin suggested that JETREA®, a proteolytic enzyme, could play an important role in the treatment of retinal disease. Since then ThromboGenics has successfully developed JETREA®, with the support of our shareholders and a range of collaborators, resulting in today’s US approval. ThromboGenics’ decision to commercialize JETREA® in the US through its own organization means that we are now in a position to maximize returns for all of our stakeholders by successfully launching this exciting innovative product.”
Dr David Boyer, Clinical Professor of Ophthalmogy, affiliated with USC/Keck School of Medicine, California and leading investigator during ThromboGenics’ clinical trials, stated: “JETREA® represents a major breakthrough for retinal specialists and their patients with symptomatic VMA. For the first time, we have a pharmacological treatment option available for many patients who would normally only be considered surgical candidates, and that is very exciting. JETREA® represents a paradigm shift in clinical practice for the global retina community and a less invasive procedure for their patients."
Symptomatic VMA is a progressive condition that if left untreated frequently leads to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications.
Market surveys conducted by ThromboGenics suggest that there are approximately 500,000 patients annually in the U.S. and the major markets of the EU who could potentially benefit from JETREA®.