BioCentury
ARTICLE | Clinical News

Aganirsen: Phase III data

May 19, 2014 7:00 AM UTC

Data from 69 patients with keratitis-related progressive corneal neovascularization in the intent-to-treat (ITT) population of the double-blind, European Phase III I-CAN trial showed that twice-daily 86 µg aganirsen eye drops per eye missed the primary endpoint of improving absolute mean visual acuity value from baseline to day 90 vs. placebo (55.06 vs. 51.86 points, p=0.982). Aganirsen met the secondary endpoint of reducing the relative mean area of corneal neovascularization from baseline to day 90 vs. placebo (9.62% reduction vs. a 16.54% increase, p=0.014), but missed the secondary endpoints of reducing the extent of neovascularization, the need for transplantation, the risk of graft rejection, QOL and complete ophthalmic evaluation scores at day 90 vs. placebo. Gene Signal said the significant reduction in the relative mean area of corneal neovascularization also persisted after 180 days compared to placebo (p=0.012). Aganirsen was well tolerated and the number of treatment-emergent adverse events was similar between groups. Ocular treatment-emergent adverse events were lower in the aganirsen arm compared to placebo arm (11.1% vs. 18.4%). Patients also received standard of care (SOC) including corticoids, antiviral and immunosuppressant therapies. Data were published in Ophthalmology. ...