DSMB backs Medidur

The treatment for diabetic macular edema (DME) involves injecting a non-erodible intravitreal device into the back of the eye to deliver a constant supply of the drug over a duration of between 18 an 36 months. There is currently no FDA approved drug therapy for DME, a condition with approximately 500,000 treatable cases of in the United States every year, and consequently Medidur has been granted fast track status by the FDA. This latest approval means that Medidur is on track for regulatory submissions in early 2010, according to Alimera CEO Dan Myers. He went on to say: "Alimera is pleased with the response from the DSMB that they have once again recommended that our investigative efforts around this treatment continue without change to the current protocol." ​ The treatment is to combat DME, which causes a breakdown of the blood-retinal barrier and a subsequent leakage of plasma elements into surrounding tissue. As this affects the back of the eye it is difficult to supply therapeutic concentrations of a drug to the affected area over a prolonged period of time. Laser photocoagulation, eye drops and injections directly into the eye have all been investigated to treat diseases affecting the back of the eye but each face unique difficulties which prevent widespread use. The Medidur technology is a tiny injectable device 3mm long and 0.37mm in diameter which delivers 0.2 or 0.5 micrograms of drug (fluocinolone acetonide, a corticosteroid to treat DME) each day. Medidur was acquired by Australian bio-nanotech company pSivida when it purchased US drug delivery firm, Control Delivery Systems (CDS). The acquisition also brought pSivida a commercial partnership with Alimera Sciences, who the technology underlying Medidur is licensed to for use in treating DME. The license agreement was recently amended, meaning Alimera cover the costs of the trials and give pSivida approximately $58m of funding in exchange for increasing their share of Medidur's profits from 50 to 80 per cent. pSivida also recently received its first payment from Pfizer, as part of the $165m agreement struck in April 2007. As part of the agreement Pfizer funds joint research into other ophthalmic applications for Medidur and in doing so gains exclusive license to market all products developed as part of the partnership.