ThromboGenics NV has announced 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 Authorization 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.