Ohr Pharmaceutical CEO Dr Irach B. Taraporewala noted that the company is excited to be working with such a prestigious group of retina specialists in this important early study.
"Drs. Boyer, Roth, and Singerman are leaders in the field of retinal research and their DME study will provide valuable new insights into the broader clinical utility of Ohr’s Squalamine Eye Drop formulation for diabetic retinal disease," Dr Taraporewala added.
OHR-005 is a randomized, placebo controlled, investigator sponsored, multicenter Phase II clinical trial evaluating the effect of Squalamine Eye Drops in patients with DME. The primary endpoints will measure change in retinal thickness and change in Best Corrected Visual Acuity (BCVA) over 24 weeks.
Secondary objectives include additional BCVA measurements, change in foveal thickness, evaluation of the need for rescue injections of ranibizumab (Lucentis®) and an assessment of the safety and tolerability of Squalamine Eye Drops.
The trial is designed to enroll up to 30 subjects at three sites in the US. Patients will be randomized to receive a single injection of ranibizumab at baseline followed by treatment with either Squalamine lactate ophthalmic solution 0.2% or placebo ophthalmic solution, administered QID for 24 weeks.