Ohr Pharmaceutical has announced that the first patient has been enrolled in a Phase III clinical trial of the company’s lead drug candidate “Squalamine”, also known as OHR-102, for the treatment of neovascular age-related macular degeneration (wet AMD).
“The Phase III clinical program will examine the potential of Squalamine, when administered as part of a combination therapy, to significantly improve visual acuity in patients with wet AMD,” said Dr. Jason Slakter, CEO of Ohr.
The first of two randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada with a target enrollment of 650 treatment subjects newly diagnosed with wet AMD.
The double-masked, placebo-controlled, multicenter, international study will be administered twice in combination with Lucentis® injections. The primary endpoint will be a measurement of visual acuity gains at nine months, with subjects followed to two years for safety. The eligibility criteria will include subjects with choroidal neovascularization (CNV) secondary to AMD.
More information about Squalamine.
More information about the trial from clinical trials.gov. (NCT02727881).