Ohr Reports Positive Interim Results From Phase II Study Of Squalamine Eye Drops

(RTTNews) - Ohr Pharmaceutical Inc. (OHRP) announced positive top-line interim results for its double-masked, placebo-controlled Phase II clinical trial of Squalamine eye drops in patients with wet age-related macular degeneration or wet AMD.

The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of +10.4 letters with Squalamine eye drops plus Lucentis® PRN versus +6.3 letters in the placebo eye drops plus Lucentis PRN arm, a 65 percent additional relative benefit (p=0.18).

The visual acuity improvements were seen as early as four weeks and the relative difference in visual acuity between the two treatment arms continued to increase throughout the study.

All patients in the study received an initial Lucentis injection followed by Lucentis as needed (PRN) based on clinical response.

The two treatment arms were Squalamine eye drops administered twice daily plus Lucentis PRN versus standard-of-care treatment: placebo eye drops administered twice daily plus Lucentis PRN.

In the interim analysis, there were no significant differences in the frequency of Lucentis PRN injections, which was the primary endpoint of the study. The mean number of Lucentis injections was 6.2 for the Squalamine arm and 6.4 for the placebo arm, which included the baseline injection and any injections required up to and including the final study visit for the interim analysis group.

The company said it plans to present the full data from this interim analysis at an ophthalmology conference in the second half of this year, with final clinical trial data expected in the first calendar quarter of 2015.