UNION CITY, Calif., Aug. 8 /PRNewswire/ -- MacuSight, Inc., a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced that the United States Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for its proprietary formulation of sirolimus (rapamycin). The IND covers the compound’s development as a treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), a manifestation of diabetic retinopathy. MacuSight intends to initiate a Phase I clinical trial of its lead product candidate in DME during the third quarter of 2006 and a Phase I trial in wet AMD during the fourth quarter of 2006.
“We are pleased with the rapid progress of our ongoing efforts to develop our proprietary sirolimus drug candidate for the treatment of serious ocular diseases and conditions such as wet AMD and DME,” said David A. Weber, Ph.D., MacuSight’s president and chief executive officer. “The therapeutic potential for this product is very exciting and we are eager to initiate our Phase I clinical trials.”
Sirolimus, originally known as rapamycin, is a highly-potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti- migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases and conditions.
“Sirolimus is a very interesting ocular drug candidate due to the fact that this broadly active compound’s mechanisms of action, not unlike steroids, are relevant to the treatment of proliferative and hyperpermeability linked diseases such as wet AMD and diabetic retinopathy,” said Mark Blumenkranz, M.D., chairman of MacuSight’s scientific advisory board and professor and chairman of the department of ophthalmology, Stanford University School of Medicine. “Additionally, the compound directly inhibits the mammalian target of rapamycin (mTOR), directly impacting immunomodulation, as well as proliferation, survival, mobility and angiogenesis. As a result, we believe that sirolimus may have great potential as a next-generation agent for several severe ocular diseases, not only as a front-line therapy of active disease but prophylaxis as well.”
To date, MacuSight has compiled preclinical data that demonstrates sirolimus’ ability to inhibit choroidal neovascularization (CNV), a hallmark of wet AMD, in both mice and rats.
As the active pharmaceutical ingredient in the FDA-approved therapeutics Rapamune(R) and the CYPHER(R) Sirolimus-eluting Coronary Stent, sirolimus has been safely administered to humans for more than six years. MacuSight has developed a proprietary minimally-invasive, extended-release administration approach for its novel liquid sirolimus formulation which it believes will provide the product with significant competitive advantages related to convenience, ease-of-use, compliance and safety.
About MacuSight
MacuSight is a privately-held pharmaceutical company focused on developing innovative therapeutics for the treatment of severe ocular diseases and conditions. The company is dedicated to preserving patients’ vision by identifying known, highly-potent and broad-acting small molecule drug compounds that may possess efficacy in treating and/or preventing diseases or conditions of the eye. At the same time, MacuSight focuses on the optimal delivery of these compounds into the eye. By combining its compounds with innovative delivery approaches, the company strives to optimize the efficacy, safety, convenience and cost-effectiveness of its product candidates.
The company’s lead development program is focused on advancing sirolimus (rapamycin) as a potential next-generation therapeutic for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), a manifestation of diabetic retinopathy, as well as the prevention of wet AMD.
MacuSight, Inc.
CONTACT: Investors, Stephanie Diaz, +1-415-675-7400, orsdiaz@vidacommunication.com, or Media, Tim Brons, +1-415-675-7402, ortbrons@vidacommunication.com, both of Vida Communication, for MacuSight
