Results from a three-year phase 3 clinical trial in which ruboxistaurin mesylate (proposed brand name Arxxant™, pronounced ark-ZONT) reduced the risk of sustained moderate vision loss by 40% vs. placebo in patients with moderate to severe non-proliferative diabetic retinopathy (DR) (1), have recently been announced by Eli Lilly & Co. (NYSE: LLY).
Once diabetes damages the small blood vessels in the retina (a part of the eye that is needed for vision), diabetic retinopathy occurs (DR). Such damage can lead to loss of vision 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)
Eli Lilly and Co. is leading the search for anti-diabetes drugs. Ruboxistaurin is its investigational therapy for the treatment of moderate to severe non-proliferative diabetic retinopathy.
Ruboxistaurin works by limiting the overactivation of protein kinase C beta (PKC beta) - a naturally occurring enzyme that has been linked to the development of diabetic retinopathy – and the first of a new class of compounds being investigated for the treatment of moderate to severe non proliferative diabetic retinopathy.
Eli Lilly is still awaiting USFDA approval of this product.
Find more details of the clinical data from the press release.
(1) Aiello, L, et al. Effect of Ruboxistaurin (RBX) on Visual Loss in Patients with Diabetic Retinopathy: Ruboxistaurin Treatment of Diabetic Visual Loss.
(2) Kempen, et al: The Prevalence of Diabetic Retinopathy Among Adults in the . Arch Ophthalmol, 122:552-563 (2004).
(3) Fong, et al: Retinopathy in Diabetes. Diabetes Care, 27:584-587(2004)
(4) Wulsin, et al: Psychosocial Correlates of Mild Visual Loss. Psychomatic Medicine, 53:109-117 (1991).
(5) Coyne et al: The impact of diabetic retinopathy: perspectives from patient focus groups. Family Practice, 21:445-451 (2004).
(6) Legood et al: Are We Blind to Injuries in the Visually Impaired? A Review of the Literature. Injury Prevention 8:155-160 (2002).
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