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news.Ohr Pharmaceutical, an ophthalmology research and development company, has announced additional interim data from the Phase II study evaluating Squalamine Eye Drops (OHR-102) for the treatment of the wet form of age-related macular degeneration ("wet-AMD").
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The data demonstrated a visual acuity and anatomical benefit for the group of patients receiving the combination of OHR-102 and Lucentis(R) PRN ("OHR-102 arm") versus placebo eye drops plus Lucentis PRN ("Lucentis monotherapy arm"). Jason Slakter, MD, retina specialist and Chief Medical Officer at Ohr, presented the data on Tuesday, August 12 at the 2014 Annual Meeting of the American Society of Retina Specialists ("ASRS").
This planned interim analysis was conducted on the first 62 patients (29 treated in the Squalamine (OHR-102) arm, 33 treated in the Lucentis monotherapy arm), who completed the entire nine months of the treatment protocol (representing approximately 50 percent of the targeted study population).
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 (OHR-102) administered twice daily plus Lucentis PRN (OHR-102 arm) versus the standard of care Lucentis monotherapy arm. Ohr previously announced data from this trial on June 24th.
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). Importantly, the visual acuity gains for the Lucentis monotherapy arm were consistent with those observed in previous clinical studies using Lucentis monotherapy treatment.
New data presented at ASRS showed that mean change in central subfield thickness was -139um in the OHR-102 arm versus -117um in the Lucentis monotherapy arm. Representative cases were shown at ASRS demonstrating that the combination of OHR-102 and Lucentis resulted in the resolution of sub-retinal hyper reflective material as well as intra-retinal and subretinal edema.
"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."
There were no significant differences in the frequency of Lucentis PRN injections, which was the primary endpoint of the exploratory Phase II study. As announced previously, the mean number of Lucentis injections was 6.2 for the OHR-102 arm and 6.4 for the Lucentis monotherapy arm, which included the baseline injection and any injections required up to and including the final study visit for the interim analysis group. Squalamine (OHR-102) eye drops were well tolerated and had a comparable safety profile to Lucentis monotherapy arm.
Given that previous combination therapy trials have focused on classic lesions, a subgroup analysis was performed on this patient population. In the group of patients with a lesion containing a classic component and a size of up to 12 disc areas, 67 percent of OHR-102 treated patients (n=18) demonstrated BCVA gains of >=3 lines on a standard ETDRS eye-chart, compared with 20 percent in the Lucentis monotherapy arm (n=15) at the end of the study (p=0.007). In addition, patients receiving OHR-102 drops were more than three times as likely to gain >=4 and >=5 lines of vision compared with patients in the Lucentis monotherapy arm (>=4 lines p=0.05, >=5 lines p=0.12). Mean change in visual acuity was +13.8 letters in the OHR-102 arm as compared to +6.7 letters in the Lucentis monotherapy arm (p=0.15).