The US Food and Drug Administration (FDA) has approved ThromboGenics' 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 US 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 US 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 programme 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.
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 US and the major markets of the EU who could potentially benefit from Jetrea.
Jetrea (ocriplasmin) is a truncated form of human plasmin that has been approved by the US Food and Drug Administration (FDA) for the treatment of symptomatic VMA. Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
Jetrea has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines.