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Ohr Pharmaceutical has 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 (AMD).
New York-Ohr Pharmaceutical has 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 (AMD).
The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints. This included a mean change in visual acuity (VA) at the end of study visit for the interim analysis group of +10.4 letters with the eye drops plus ranibizumab as needed (PRN), versus +6.3 letters in the placebo eye drops plus ranibizumab PRN arm, a 65% additional relative benefit (p = 0.18).
The VA improvements were seen as early as 4 weeks and the relative difference in VA between the two treatment arms continued to increase throughout the study.
All patients received an initial ranibizumab injection followed by further injections PRN based on clinical response.
The two treatment arms were the eye drops administered twice daily plus ranibizumab PRN ("eye drop" arm or group) versus standard-of-care treatment: placebo eye drops administered twice daily plus Ranibizumab PRN ("placebo" arm or group).
The planned interim analysis was conducted on the first 62 patients (29 treated in the eye drop arm, 33 treated in the placebo arm), who completed the entire 9 months of the treatment protocol (representing approximately 50% of the targeted study population).
The eye drop-treated group demonstrated improved best-corrected visual acuity (BCVA) gains relative to the placebo group at all timepoints evaluated from 4 to 38 weeks. In the interim analysis group, 48.3% of eye drop-treated patients showed BCVA gains of ≥ 15 letters (≥ 3 lines) on a standard eye chart, compared with 21.2% in the placebo arm at the end of the study (p = 0.025). In addition, patients receiving the drops were more than twice as likely to gain ≥ 4 and ≥ 5 lines of vision compared with patients in the placebo eye drop arm (≥ 4 lines p = 0.022, ≥ 5 lines p = 0.059).
The VA gains for the placebo eye drop arm were also consistent with those observed in previous clinical studies using ranibizumab monotherapy treatment. The eye drops were well tolerated and had a comparable safety profile to placebo eye drops.
"The beneficial effects of (the eye drop) on VA that we've seen thus far, through its inhibition of multiple angiogenic growth factors and pathways, and in particular, the improvement in gains of three or more lines in vision compared with the placebo group, are truly remarkable," said Jason Slakter, MD, chief medical officer of Ohr and retina specialist at Vitreous-Retina-Macula Consultants of NY. "VA is the most clinically relevant endpoint for back-of-the-eye disorders. For wet AMD patients, such enhanced gains of VA over standard-of-care anti-VEGF treatments, and the restoration of vision lost to this devastating disease of the elderly using a convenient eye drop therapy is a very important clinical outcome."
In the interim analysis, there were no significant differences in the frequency of ranibizumab PRN injections, which was the primary endpoint of the study. The mean number of injections was 6.2 for the eye drops 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.
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