美国Psivida
pSivida是一个发展中的小型化,注射,药物输送系统的领导。我们开发产品,以治疗严重或危及生命的疾病,单独或与其他公司合作。我们已经开发出的设备是如此之小,他们是FDA批准进入眼内的管理,一旦管理他们释放其药物的几个月甚至几年。
pSivida is a leader in the development of miniaturized, injectable, drug delivery systems. We develop products to treat serious or life threatening diseases alone or in partnership with other companies. We have developed devices that are so small they are FDA approved to be administered into the eye and once administered they release their drug for months and years.
pSivida's lead development product, ILUVIEN™, delivers fluocinolone acetonide (FA). It is designed to be injected into the eye to provide sustained release into the back of the eye for up to three years after a single injection. ILUVIEN has completed two three-year Phase III clinical trials in Diabetic Macular Edema, one of the leading causes of blindness in the developed world. The NDA was submitted to the FDA in May 2011 by our licensee Alimera Sciences and the review is expected to be completed by the end of 2011. ILUVIEN is also in Phase II clinical trials in dry age-related macular degeneration, wet age-related macular degeneration and retinal vein occlusion. These studies are being conducted by Alimera Sciences.
pSivida's two FDA approved sustained release products to treat chronic back of the eye diseases are Retisert® for the treatment of posterior uveitis and Vitrasert™ for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. Vitrasert and Retisert provide sustained release for six to nine months and two and a half years, respectively.
pSivida has a world wide collaborative Research and Development agreement with Pfizer Inc. to develop a long term sustained release implant to deliver latanoprost for patients with ocular hypertension and glaucoma. This collaboration is focused on developing a bioerodible version of pSivida's proprietary Durasert® technology designed to be injected into the subconjunctival space of the eye.
pSivida is developing a series of additional miniaturized, bioerodible sustained release technologies to deliver a range of proteins and small drug molecules to virtually any site in the body. One of these technologies is Tethadur®, a nanostructured bioerodible material.
pSivida's intellectual property portfolio consists of 180 patents either issued or granted for acceptance, over 150 pending applications and 60 patent families.