ThromboGenics, a Belgium-based biopharmaceutical company focused on ophthalmic medicines, has published data from two phase III clinical trials evaluating ocriplasmin for the treatment of Vitreomacular Adhesion (VMA) and macular holes in the New England Journal of Medicine.
The paper highlights that a single intravitreal injection of ocriplasmin resolved VMA, releasing traction and closing macular holes in significantly more patients than placebo.
The two multinational, randomized, double-blind phase III trials enrolled 652 patients with VMA, 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. 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.
"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,” said Dr. Julia Haller, ophthalmologist-in-chief of the Wills Eye Institute.
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. Ocriplasmin is also currently under regulatory review by the EMA. In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the U.S.