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Ohr enrolls first patient in phase 3 clinical trial of squalamine for wet AMD
Ohr Pharmaceutical has enrolled the first patient in the first of two phase 3 clinical trials of squalamine lactate ophthalmic solution 0.2% for the treatment of neovascular age-related macular degeneration, according to a press release.
The phase 3 clinical program will include two randomized, double-masked, placebo-controlled trials of squalamine (OHR-102). The first trial has a target enrollment of 650 patients who are newly diagnosed wet AMD and will be administered OHR-102 in combination with Lucentis (ranibizumab, Genentech) twice a day.
The primary endpoint of the clinical trial will be visual acuity gains at 9 months. Patients will have follow-up visits for 2 years to measure safety outcomes.
“The phase 3 program is designed to provide the data required for regulatory approval in major ophthalmic markets worldwide,” Jason Slakter, MD, CEO of Ohr, said in the release.
In March, the company and the FDA reached an agreement on a special protocol assessment for the program.