Ohr presents two Squalamine Phase 2 data sets
Trial data for retinal vein occlusion and wet age-related macular degeneration detailed at 2014 ASRS meeting
NEW YORK—Ohr Pharmaceutical Inc., an ophthalmology research and development company, presented data supporting the use of Squalamine Eye Drops (OHR-102) in the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). The data reportedly demonstrated that the combination of topical Squalamine eye drops and intravitreal Lucentis led to a mean gain in visual acuity (VA) of 20.3 letters and resolution of the fovial edema in 95 percent of the patients at week 10.
Dr. John Wroblewski, retina specialist at Cumberland Valley Retina Consultants, presented the 10-week data at the August 2014 Annual Meeting of the American Society of Retina Specialists (ASRS).
“I am encouraged by the data using a combination approach with Squalamine to treat retinal vein occlusions,” said Wroblewski, principal investigator of the study. “The early effect on visual acuity, edema and percentage of early responders appears to be better than those seen in historical monthly Lucentis retinal vein occlusion trials. I look forward to the completion of the extension stage of the study and presenting those results in the first quarter of 2015.”
This investigator-sponsored trial was designed to determine the effect of OHR-102 in eyes with macular edema secondary to retinal vein occlusion. Twenty treatment-naïve patients with macular edema due to retinal vein occlusion were enrolled: nine with non-ischemic CRVO, eight with BRVO and three with hemi-central RVO (HRVO).
All 20 patients received OHR-102 for the first ten weeks of treatment, with two injections of Lucentis given at week two and week six. At week 10, the average EDTRS letter gain was +18.2 for CRVO, +18.1 for BRVO and +32.3 for HRVO. In addition, 80 percent of patients achieved gains of ≥3 lines in visual acuity, with 40 percent of patients achieving gains of ≥4 lines in VA. Overall, mean Snellen visual acuity at week 10 was 20/32 for all groups, and there was a mean improvement in central fovial thickness on optical coherence tomography (OCT) from 723 to 270 microns. Only one patient out of the 20 required an injection of Lucentis at week 10 using predefined OCT-based rescue criteria.
In the second Phase 2 study, Ohr announced additional interim data from the evaluation of OHR-102 for the treatment of the wet form of age-related macular degeneration (wet AMD). The data demonstrated a visual acuity and anatomical benefit for the group of patients receiving the combination of OHR-102 and Lucentis PRN (OHR-102 arm) vs. placebo eye drops plus Lucentis PRN (Lucentis monotherapy arm).
Dr. Jason Slakter, retina specialist and chief medical officer at Ohr, presented those data at the 2014 Annual Meeting of ASRS.
This planned interim analysis was conducted on the first 62 patients (29 treated in the OHR-102 arm, 33 treated in the Lucentis monotherapy arm), who completed the entire nine months of the treatment protocol. 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 OHR-102 administered twice daily plus Lucentis PRN (OHR-102 arm) vs. the standard-of-care Lucentis monotherapy arm.
The OHR-102-treated group demonstrated improved best-corrected visual acuity (BCVA) gains relative to the Lucentis monotherapy group at all timepoints evaluated from four to 38 weeks. In the interim analysis group, 48.3 percent of OHR-102-treated patients showed BCVA gains of ≥15 letters (≥3 lines) on a standard ETDRS eye chart, compared with 21.2 percent in the monotherapy arm at the end of the study (p=0.025). In addition, patients receiving OHR-102 drops were more than twice as likely to gain ≥4 and ≥5 lines of vision compared with patients in the Lucentis monotherapy arm (≥4 lines p=0.022, ≥5 lines p=0.059). Mean gain in visual acuity was +10.4 letters in the OHR-102 arm vs. +6.3 letters in the Lucentis monotherapy arm (p=0.18).
New data showed that mean change in central subfield thickness was -139µm in the OHR-102 arm versus -117µm in the Lucentis monotherapy arm.
“The enhanced vision gains of OHR-102 in combination with Lucentis over the Lucentis monotherapy regimen are encouraging,” said Dr. Jeffrey Heier, director of the Vitreoretinal Service at Ophthalmic Consultants of Boston, member of Ohr’s scientific advisory board and study investigator. “Visual acuity is the primary concern of our patients, and to be able to potentially augment their visual function with a non-invasive option would be of great benefit to them.”
Squalamine is currently being studied as an eye-drop formulation in several company-sponsored and investigator-sponsored Phase 2 clinical trials for various back-of-the-eye diseases, including wet AMD, retinal vein occlusion, diabetic macular edema and proliferative diabetic retinopathy.
In May 2012, the Squalamine program was granted Fast Track designation by the U.S. Food and Drug Administration. In addition, Ohr is developing a sustained release micro-fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies and protein drug delivery.