Ohr announces positive interim clinical results from phase 2 wet AMD treatment study
Ohr Pharmaceuticals has announced that its phase 2 study of Squalamine eye drops for the treatment of wet age-related macular degeneration has produced positive top-line interim results, according to a company press release.
“The data further validate not only the clinical utility of noninvasive topical eye drop therapies for macular and retinal disorders, but also the soundness of our company’s drug development science and our proprietary formulation technologies that enable topical dosing to achieve positive therapeutic effects in back-of-the-eye disorders,” Irach B. Taraporewala, Ohr president and CEO, said in the release.
The randomized, double-masked, placebo-controlled phase 2 study is currently underway to evaluate the efficacy and safety of Squalamine drops and as-needed dosing of Lucentis (ranibizumab, Genentech) for the treatment of wet AMD, the release said. All patients received a single injection of ranibizumab and were then randomly assigned to receive either placebo eye drops or Squalamine drops administered twice daily for 9 months plus ranibizumab PRN. Of the 142 patients included in the study, 62 had completed the treatment period by the interim analysis.
“It is noteworthy that the visual benefits of Squalamine in these patients occurred quite early in the course of treatment, since there were no four-line gainers whatsoever in the placebo-treated patient group at the 4- and 12-week time points vs. approximately 17% in the Squalamine treatment group,” Jason Slakter, MD, Ohr chief medical officer, said during a conference call.
At week 38, 48.3% of patients in the Squalamine group had best corrected visual acuity gains of 15 letters or more, compared with 21.2% in the placebo group. Additionally, nearly 50% of Squalamine-treated patients showed an improvement in visual function compared with 20% of the placebo group. Mean number of Lucentis injections was 6.2 in the Squalamine group and 6.4 in the placebo group.
Ohr will present the full data from the interim analysis at an ophthalmology conference during the second half of 2014, with final clinical results expected in the first quarter of 2015, according to the release.