LEUVEN, Belgium, August 15, 2012 /PRNewswire/ --
Paper highlights that ocriplasmin is superior to placebo in resolving VMT and closing macular holes in patients with Vitreomacular Adhesions
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, announces that the data from two Phase III clinical trials evaluating ocriplasmin for the treatment of vitreomacular traction (VMT) and macular holes will be published in the New England Journal of Medicine on 16 August 2012. The paper highlights that a single intravitreal injection of ocriplasmin resolved Vitreomacular Adhesion (VMA), releasing traction and closing macular holes in significantly more patients than placebo. VMT is also referred to as symptomatic Vitreomacular Adhesion.
The two multicenter, randomized, double-blind Phase III trials with ocriplasmin were conducted in the U.S. and Europe and involved 652 patients with VMA. Both studies met the primary endpoint of pharmacological resolution of VMA at day 28. Secondary endpoints included nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy (surgery) and improvement in visual acuity.
The Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.001). Nonsurgical closure of macular holes occurred in 40.6% of ocriplasmin-treated patients, compared with 10.6% of patients on placebo (p<0.001). Patients given ocriplasmin were more likely to achieve a vision gain of at least three lines compared with placebo. Treatment with ocriplasmin was associated with some, mainly transient ocular adverse events.
Dr Patrik De Haes, CEO of ThromboGenics, said: "The publication of the data from our pivotal Phase III trials with ocriplasmin in this prestigious peer-reviewed journal highlights the potential of this novel pharmacological approach for the treatment of VMA and associated VMT. Following the FDA advisory panel's decision last month to recommend ocriplasmin for the treatment of symptomatic VMA, we are continuing to work closely with the Agency so that we can make ocriplasmin available to patients in the U.S. if approved."
Dr Julia Haller, Ophthalmologist-in-Chief of the Wills Eye Institute, and Professor and Chair of the Department of Ophthalmology at Thomas Jefferson University, said: "This New England Journal of Medicine paper highlights data showing ocriplasmin's potential to become the first pharmacological option for the treatment of symptomatic VMA and macular holes. An in-office injection would be a new and possibly earlier alternative treatment for the vitreoretinal surgeon to offer to patients with these sight threatening disorders. Ocriplasmin represents a potential new treatment paradigm for the retina community and for our patients with VMA and macular holes."
ThromboGenics has made regulatory filings for ocriplasmin in both the U.S. and Europe. Last month, an FDA advisory panel recommended the approval of ocriplasmin for the treatment of symptomatic VMA. If approved, the Company plans to commercialize ocriplasmin itself in the U.S. In Europe ocriplasmin is currently under regulatory review by the European Medicines Agency (EMA). In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States.
Kevin Buehler, Division Head, Alcon, said: "The data published in the NEJM have formed a key part of the ocriplasmin European Marketing Authorisation Application that is currently under review by the EMA. With Alcon's extensive commercial capabilities, geographic footprint and strong relationships with retinal specialists and ophthalmologists, we are well positioned to bring what we believe is a truly innovative treatment option to patients suffering from VMT and macular holes in Europe and other countries outside the United States."
Symptomatic VMA or VMT 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 research conducted by ThromboGenics suggests that there are approximately 500,000 patients in the U.S. and the major EU markets who could potentially benefit from ocriplasmin annually. If approved, ocriplasmin will be the first pharmacological treatment for symptomatic VMA.
ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic Vitreomacular Adhesion (VMA), otherwise termed Vitreomacular Traction (VMT). The Marketing Authorisation Application (MAA) for ocriplasmin has been accepted for review in Europe and in the U.S. the FDA has accepted the Biologics License Application (BLA) filing and granted it Priority Review. A recent FDA Advisory Committee has issued a positive recommendation supporting the approval of ocriplasmin for the treatment of symptomatic VMA.
In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement, ThromboGenics could receive up to a total of 375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.
ThromboGenics is also developing TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.
1. "Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes," Stalmans P., et al., New England Journal of Medicine. 2012; 367;7. Published 16 August 2012
For further information please contact:
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Citigate Dewe Rogerson
David Dible/ Nina Enegren/ Sita Shah
The Trout Group
Todd James/ Simon Harnest
SOURCE ThromboGenics NV