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Ruboxistaurin Reduces Vision Loss

Nov 21, 2006

Once daily, oral investigational therapy reduced sustained Moderate vision loss by 40% over three-year period for patients with moderate to severe non-proliferative diabetic retinopathy. Ruboxistaurin mesylate (proposed brand name Arxxant(TM), pronounced ark-ZONT) reduced the risk of sustained moderate vision loss by 40 percent when compared to placebo in patients with moderate to severe non-proliferative diabetic retinopathy (DR).

Diabetic retinopathy (DR) occurs when diabetes damages the small blood vessels in the retina, a part of the eye that is needed for vision. This damage can lead to vision loss and possible blindness. DR affects an estimated 4.1 million Americans age 40 and older, with 899,000 having a vision-threatening form of the disease,(2) and it is the leading cause of blindness among working-age adults.(3) Yet blindness is only a part of the story. Even moderate vision loss can lead to difficulties in reading, driving, employment, and mobility as well as an increased risk of accidental injuries.(4,5,6)


The recent study showed that vision loss (measured in the study as sustained moderate vision loss or SMVL) occurred in only 5.5 percent of patients treated with ruboxistaurin compared to 9.1 percent of patients treated with placebo, equaling a 40 percent relative risk reduction (P=0.034) over three years.(1) Vision loss (SMVL) was defined as a three-line loss on a standard eye chart that was sustained for at least 6 months.(1)

The study findings were recently published online in the in press version of Ophthalmology [http://www.ophsource.org/periodicals/ophtha/inpress] and will be published in the print version of the December 2006 issue of Ophthalmology.


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