Acucela launches phase 2 clinical trial of oral dry AMD therapy Acucela announced the launch of its ENVISION Clarity Trial, a Phase 2 clinical trial of ACU-4429, an investigational oral treatment for dry age-related macular degeneration (AMD).

ACU-4429 utilizes Acucela's proprietary visual cycle modulation (VCM) technology, and is designed to prevent or inhibit the generation of toxic by-products of the visual cycle that can lead to degenerative eye conditions like dry AMD.

Preclinical data indicate that ACU-4429 slows the rod visual cycle, resulting in decreased accumulation of a toxic by-product that is the precursor of lipofuscin, which are deposits of toxic substances. The chronic accumulation of lipofuscin has been implicated in degenerative retinal diseases. ACU-4429 is administered to patients as an oral, daily pill rather than by injection into the eye, which is typical of many current eye therapeutics.

The ENVISION (Evaluating a Novel VISION treatment for AMD) Clarity Trial is part of Acucela's clinical program evaluating the investigational oral treatment ACU-4429 in patients with dry AMD. This Phase 2 trial is a randomized, double-masked, placebo-controlled study of three planned escalating dose levels of ACU-4429 and up to two additional dose levels in subjects with dry AMD. Patients will receive either ACU-4429 or placebo orally once daily for three months. The trial will be conducted at multiple sites throughout the U.S. and is overseen by an independent Data Monitoring Committee that will approve each escalation in dose. It is anticipated that a minimum of 56 patients with dry AMD will be enrolled.

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