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news.Japan-based Santen Pharmaceutical has commenced Phase I/IIa human trials of steroidal treatment for macular edema, DE-102, using Oakwood’s Chroniject sustained release delivery technology.
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The product’s microsphere formulation as well as sterile filling was accomplished at Oakwood’s Cleveland manufacturing facility.
Oakwood Laboratories’ proprietary Chroniject technology has been shown to offer an adaptable and easily scaleable system for the development and manufacture of injectable sustained release dosage forms of multiple drug classes. A distinct benefit of the technology is its ability to offer customizable release profiles as well as control of the duration of delivery. It can also be used to target therapy to specific areas of the body.
The company expects DE-102 will improve patients’ quality of life, as well as enhance its pipeline of products in this area.
Mark Smith, president of Oakwood, said: “Oakwood is very pleased to have been able to solve some difficult technical issues in order to bring this product to commercial manufacturing scale, and to the point of clinical use. We look forward to the continued development of this product.”