genesignal: Gene Signal publishes mixed data for aganirsen

Data published in Ophthalmology showed that twice-daily aganirsen (GS-101) eye drops from Gene Signal International S.A. (Lausanne, Switzerland) missed the primary endpoint of improving absolute mean visual acuity value from baseline to day 90 vs. placebo in the Phase III I-CAN trial to treat keratitis-related progressive corneal neovascularization (55.06 vs. 51.86 points, p=0.982). Aganirsen did meet 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). Aganirsen is an antisense oligonucleotide targeting insulin receptor substrate 1 (IRS1) mRNA.The data included 69 patients with corneal neovascularization secondary to keratitis or keratouveitis of bacterial, viral or traumatic origin in the intent-to-treat (ITT) population of the double-blind, European trial. Gene Signal said it plans to discuss the I-CAN data with regulatory authorities "to design a short confirmatory pivotal trial."