Lpath has initiated enrolment in Phase Ib/IIa trial of iSONEP, the company’s ocular drug candidate, in patients with retinal pigment epithelium detachment.
The Phase Ib/IIa trial will enrol 32 subjects with pigment epithelium detachment, who will receive up to three monthly intravitreal injections of iSONEP. Two dose levels will be evaluated.
The primary endpoint of the study is the tolerability of consecutive monthly injections, while the primary efficacy endpoint is the percentage of subjects that experience flattening of their pigment epithelium detachment.
In the company’s Phase I trial, subjects with wet age-related macular degeneration received only one injection of iSONEP.
The study met its primary endpoint of being well tolerated in all 15 patients and also met a key secondary endpoint of positive biological effect.
The company is planning to begin a Phase II human proof-of-concept trial of iSONEP in June 2011, which will evaluate the efficacy and safety of iSONEP in wet age-related macular degeneration patients that do not have pigment epithelium detachment.
Pigment epithelium detachment is a potentially serious condition that is often part of the pathology of wet age-related macular degeneration and polypoidal choroidal vasculopathy; no drug has yet been approved to treat this condition.