US-based biopharmaceutical company Inspire Pharmaceuticals has announced that the standard 30-day review period by the FDA relating to the company's investigational new drug application for INS117548 ophthalmic solution for the treatment of glaucoma has concluded and clinical testing can proceed.
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Inspire is currently targeting the initiation of a Phase I clinical trial by the end of 2008 to evaluate the tolerability and efficacy of this product candidate in subjects with early stage glaucoma or ocular hypertension.
According to the company, INS117548 is a rho kinase inhibitor designed to lower intraocular pressure in glaucoma patients by disrupting the actin cytoskeleton (cellular skeleton) of the trabecular meshwork, an ocular tissue responsible for most of the outflow of aqueous humor.
The technology platform that led to the discovery of INS117548 is based on a license agreement with the Wisconsin Alumni Research Foundation for use in developing and commercializing new therapies to treat glaucoma. Inspire has an additional compound, INS115644, related to this platform that is also in Phase I clinical testing.
Paul Kaufman, professor and chair, department of ophthalmology and visual sciences of the University of Wisconsin-Madison, said: “For many patients, current treatments have limited benefit or multiple eye drops must be used to keep the disease under control. Inspire has made excellent progress in moving this program from the preclinical stage to human clinical testing with multiple compounds being studied to provide critical information about this targeted approach.”
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