ThromboGenics, a company specializing in biotherapeutics for vascular diseases, cancer, and eye diseases, has announced the start of a Phase II trial of microplasmin to treat age-related wet macular degeneration (AMD).
Wet AMD occurs when abnormal blood vessels behind the retina begin to grow under the macula, the part of the eye responsible for seeing detail. These blood vessels tend to be fragile and often leak blood and fluid, causing the macula to become raised from its normal position at the back of the eye. Damage to the macula may result, leading to vision loss.
It was recently discovered that one-third of patients with AMD have focal vitreomacular adhesion, a condition in which the vitreous gel in the center of the eye has an abnormally strong adhesion to the retina at the back of the eye. The same adhesion occurs in patients with wet AMD. Microplasmin is designed to treat vitreomacular adhesion by separating the vitreous gel from the retina, potentially preventing the progression of wet AMD.
The MIVI5 (Microplasmin for IntraVitreous Injection) trial will enroll approximately 100 patients across up to 20 European medical centers. The goal is the non-surgical resolution of vitreomacular adhesion. Safety and efficacy will also be evaluated during a one-year follow-up period.
Belgium-based ThromboGenics is also testing microplasmin as a treatment for diabetic retinopathy and diabetic macular edema, vision problems related to diabetes. AMD is the most common cause of vision loss in patients 50 or older. It represents an estimated $1 billion annual market. Other companies working in this sphere include ScyFix, NeoVista, VisionCare Ophthalmic Technologies and Oraya Therapeutics.