Ohr Pharmaceutical recently announced details of the planned Phase III registration trials for squalamine eye drops (OHR-102) in the treatment of wet age-related macular degeneration (AMD), which are being designed based on guidance provided by the U.S. Food and Drug Administration (FDA) at a recent "end of Phase II" meeting.
New York-Ohr Pharmaceutical recently announced details of the planned Phase III registration trials for squalamine eye drops (OHR-102) in the treatment of wet age-related macular degeneration (AMD), which are being designed based on guidance provided by the U.S. Food and Drug Administration (FDA) at a recent "end of Phase II" meeting.
Ohr and the FDA has agreed on a nine-month primary efficacy endpoint based on the proportion of patients achieving a three or more line gain in visual acuity. In the interim analysis of the ongoing Phase II IMPACT study, more than twice the proportion of patients achieved three or more line gains in visual acuity at nine months with the combination of OHR-102 eye drops and Lucentis (ranibizumab, Genentech) as compared to the Lucentis monotherapy group (overall p=0.025, classic lesions p=0.007).
“Our recent meeting has provided us with valuable input to formulate a clear regulatory strategy for OHR-102," says Dr. Irach Taraporewala, president and CEO of Ohr. "Importantly, the Agency has agreed with our plan to use visual acuity, as defined by gains of three or more lines at nine months, as the primary endpoint in Phase III trials. Visual acuity is the most clinically relevant endpoint for retinal disease.”
Two identical Phase III studies will be performed. Ohr plans to initiate the Phase III trials in the first half of 2015 with the goal of submitting a New Drug Application (NDA) following collection and analysis of the nine-month primary efficacy data.
The Phase III trials for squalamine eye drops are being designed to measure the efficacy of combination therapy with OHR-102 eye drops plus Lucentis injections vs. Lucentis monotherapy at nine months. All patients will be followed for safety for two years. The primary endpoint will be a measure of improvement in visual acuity, as defined by the proportion of patients achieving gains of three or more lines on the early treatment diabetic retinopathy study chart.
During the first year of the study, patients will be randomized one-to-one to receive monthly Lucentis plus OHR-102 (squalamine eye drops) twice a day or Lucentis plus placebo. During the second year they will receive Lucentis PRN (as needed) plus OHR-102 or placebo twice a day.