Ohr Pharmaceutical (OHRP) on Tuesday released interim results from a phase 2 study of its Squalamine eye drops in Wet Age-related Macular Degeneration (AMD). Squalamine eye drops, despite improving visual acuity compared to placebo in wet AMD patients, failed to reduce the frequency of Lucentis (ranibizumab) injections, which was the primary endpoint of the study. The mean number of Lucentis injections was 6.2 for the Squalamine + Lucentis arm, and 6.4 for the placebo + Lucentis arm. The primary endpoint miss was not evident in the press release until the fifth paragraph.
For Ohr and its investors, squalamine reducing the amount/frequency of Lucentis (ranibizumab) injections would have been a homerun, suggesting utility as a combination therapy with the leading wet AMD treament. OHRP is down 10% in pre-market trading. Final clinical data are expected in the first quarter of 2015.
At the interim analysis, the data did demonstrate a benefit in visual acuity in the squalamine arm of +10.4 letters versus +6.3 letters in the placebo arm, a 65% additional relative benefit, though not statistically significant (p=0.18). Almost half of Squalamine-treated patients showed BCVA (best-corrected visual acuity) gains of >= 3 lines on a standard eye-chart, compared with 21.2% in the placebo arm (p=0.025).
The interim analysis was conducted on the first 62 patients (29 in the Squalamine arm, 33 in the placebo arm) who completed the entire nine months of the treatment protocol (about 50% of the targeted total population). Patients received an initial intra-vitreal injection of Lucentis before 1:1 randomization to receive a daily dose of either Squalamine eye drops or placebo eye drops administered twice daily for nine months.
Ohr will present full data from this interim analysis at an ophthalmology conference in the second half of the year.
