Microplasmin may satiate the need for a simpler Vitrectomy!
Jan 19, 2005 - 3:12:00 PM
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By Akanksha,Pharmacology Correspondent,
[RxPG] Vitrectomy is a surgical procedure during which the vitreous is separated from the retina, inducing a posterior vitreous detachment (PVD).This technique is considered beneficial in patients with numerous retinal conditions, including diabetic retinopathy and macular edema.
More than 500,000 vitrectomies are performed annually worldwide (more than 200,000 in the U.S.), most commonly for complications related to diabetic retinopathy. Diabetic retinopathy affects more than 5.4 million Americans, and is the leading cause of blindness in the working-age population. Vitrectomy is also performed to treat macular edema, which affects 1.6 million people worldwide, including 650,000 Americans.
Microplasmin is a truncated form of the human protein plasmin & research has shown that it has the potential to simplify vitrectomy by inducing posterior vitreous detachment (PVD).
ThromboGenics Ltd. has announced the start of a Phase II trial evaluating recombinant microplasmin in patients with vitreoretinal disorders.
The difficulties involved in inducing a PVD by surgical vitrectomy is well known.In this setting,a drug given prior to vitrectomy that could facilitate this process may lead to more rapid surgery with fewer complications.It could also lead to treatment in an office-based setting for conditions that otherwise would have required surgery.
The breakthrough procedure using plasmin for induction of PVD was invented by Drs. Michael Trese and George Williams, the founders of NuVue Technologies, which owns exclusive rights for the use of plasmin in ophthalmic applications. A formal licensing agreement between ThromboGenics and NuVue brings into a single portfolio all intellectual property relating to plasmin-based compounds for treatment of eye diseases.
This Phase II trial is primarily designed to provide valuable safety information on the use of microplasmin in this setting, on which dose selection for future clinical trials can be based. Subject to interim results from this trial, ThromboGenics plans to submit an Investigational New Drug (IND) application to FDA to allow for initiation of a U.S. clinical trial with microplasmin in 2005.
ThromboGenics has performed extensive pre-clinical work with microplasmin, including toxicology and pharmacology studies, in the laboratories of several prominent researchers in the vitreoretinal field. A Phase I trial for systemic administration of microplasmin has also been successfully completed.
Advancement of this program into Phase II is an exciting milestone for our company, stated Désiré Collen, M.D., Ph.D., Chairman and CEO of ThromboGenics, adding The potential of microplasmin to fill a significant unmet need, both as an adjunct to vitrectomy and as an agent that could allow office-based treatment, continues to generate substantial excitement in the ophthalmic community.
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ThromboGenics Ltd. is a privately held company founded in Dublin, Ireland, focused on biotherapeutics for the prevention and treatment of heart attack, stroke, peripheral artery disease, eye disease, and cancer.More information can be found at the company's web site.
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