Oakwood Laboratories, L.L.C. and Santen Pharmaceutical Co., Ltd., of Osaka, Japan, have entered into an agreement for the licensing of Oakwood’s drug delivery technology for use with Santen’s steroidal product (DE-102) to treat Diabetic Macular Edema (DME). Under the agreement, Oakwood will provide formulation and dosage form development, and manufacturing of clinical and commercial scale supplies of DE-102, using Oakwood’s Chroniject microsphere-based sustained release injectable technology.

DME is an ophthalmic disorder associated with swelling of the retina in diabetes mellitus due to leaking of fluid from blood vessels within the macula, which is in the central portion of the retina. The severe deterioration of DME can cause failing vision or vision loss. Currently, the major treatments for DME are endophotocoagulation or surgery.

“Santen is committed to improving the effectiveness of drugs to treat DME, utilizing enhanced drug delivery,” said Toshiaki Nishihata, Ph.D., Santen’s head of R&D. “DE-102 has demonstrated sustained efficacy when injected around the affected area. Producing sterile microspheres in commercial scale requires the technology and facilities that Oakwood will provide.”

“We are pleased to be entering into this important relationship with Japan’s premier ophthalmic company,” said Mark T. Smith, president and chief executive officer of Oakwood. “ It is a tribute to both the expertise of our personnel and the strength of our Chroniject drug delivery technology. Oakwood’s feasibility study provided Santen with robust proof-of-concept, and the confidence to move forward with us on the development of this exciting product.”