Bausch and Lomn and the drug delivery specialists Control Delivery Systems announced promising results to a clinical trial of an ophthalmic implant for the treatment of diabetic macular oedema.
Patients receiving the implant in the phase III randomised controlled clinical trial showed a reduction in macular oedema and in the severity of their diabetic retinopathy, and they also showed improved or stabalised visual acuity. There was no difference in serious adverse events between implant treated patients and those receiving standard procedures care. The device which is implanted in the back of the eye holds a tiny drug reservoir enabling sustained, consistant delivery of the drug fluocinolone acetonide directly to the affected area for up to three years.

The results of these trials are expected to lead to a new drug application to be filed next year under the USA Food and Drug Administration accelerated approval proccess

     Listing # 25 May 2002