Alcon gains exclusive ex-US rights for ocriplasmin
Posted: 16 March 2012 | | No comments yet
Potential first pharmacological treatment for symptomatic vitreomacular adhesion…
Alcon, the global leader in eye care and a division of Novartis, announced today that it has gained exclusive rights to commercialize ocriplasmin outside the United States for the treatment of symptomatic vitreomacular adhesion (VMA). If approved, it will be the first pharmacological treatment for patients with symptomatic VMA, including macular hole. Symptomatic VMA is a progressive, debilitating eye disease that may lead to visual distortion, loss in visual acuity and central blindness.
Alcon is licensing ocriplasmin from ThromboGenics, a bio-pharmaceutical company based in Belgium. The agreement grants Alcon exclusive commercial rights outside the United States. Under the terms of the agreement, Alcon will make an upfront payment of 75 million (approx. USD 100 million) to ThromboGenics with additional potential payments based on milestones, as well as royalties on sales of ocriplasmin, if approved.
“There are thousands of symptomatic vitreomacular adhesion patients who currently do not have an available treatment option. The clinical results for ocriplasmin show improved visual function and that earlier intervention may limit the progression of the disease,” said Kevin Buehler, Division Head Alcon. “Ocriplasmin is a strategic fit for Alcon and is expected to further enhance our portfolio of innovative treatments for the eye.”
Ocriplasmin is currently under review with the European Medicines Agency (EMA) as the first pharmacological treatment for symptomatic VMA, including macular hole. The drug was accepted for review by the EMA in October 2011. ThromboGenics retains the rights to commercialize ocriplasmin in the United States and a decision on approval is expected from the US Food and Drug Administration (FDA) in the second half of 2012.
Symptomatic VMA primarily involves the interface between the retina’s highly sensitive macular area, which is responsible for detailed, central vision, and the posterior vitreous membrane, which separates the clear, jelly-like substance in the center of the eye, called vitreous, from the retina.
With symptomatic VMA patients, the vitreous adheres in an abnormally strong way to the retina, which can lead to traction (‘pulling’) on the retina, causing symptoms including impaired vision. Further unresolved traction may lead to the development of macular holes and central blindness.
For many symptomatic VMA patients, there is no recommended treatment available. More than 300,000 symptomatic VMA patients in Europe alone could potentially benefit from this new treatment, if approved. The standard of care for patients advancing to late stage VMA is surgical vitrectomy.
Ocriplasmin is a recombinant truncated form of human protein (plasmin) administered through a one-time intra-vitreal injection. Clinical data1 demonstrate that ocriplasmin resolves symptomatic vitreomacular adhesion (VMA), on average within seven days, reducing the number of patients advancing to surgery.
The ocriplasmin in-licensing agreement confirms Alcon’s commitment to bringing innovative eye care treatments to patients with unmet medical needs. With the company’s extensive commercial capabilities, geographic footprint and strong relationships with retinal specialists and ophthalmologists around the globe, Alcon is well positioned to bring this innovative treatment to patients around the world.
- Thrombogenics. MIVI-TRUST Phase III Clincal Data.
- Alcon internal estimates.
- Trese M, Kaiser P, Dugel P, Brown D, & Humayun M (2011). Symptomatic Vitreomacular Adhesion (VMA): Diagnosis, Pathologic Implications, and Management. Retina Today, July/August (Supplement).
Alcon Inc., EMA, Food and Drug Administration (FDA), Novartis