DOC News October 1, 2006
Volume 3 Number 10 p. 5
© 2006 American Diabetes Association
FDA Requests More Data on Retinopathy Drug
Elizabeth Thompson Beckley
The U.S. Food and Drug Administration (FDA) in August asked Eli Lilly for
additional data on ruboxistaurin (Arxxant) to support clinical evidence the
company presented in February in its new drug application for this
investigational oral therapy for diabetic retinopathy.
Lilly says it plans to meet with the FDA to determine if a new study is
required or if the agency's request can be satisfied with data from an ongoing
study.
"I think it's appropriate that the FDA asked for that
information," says ophthalmologist Victor H. Gonzalez, MD, of the Valley
Retina Institute in McAllen, Tex. "This is a systemically administered
drug. One needs to be very careful with that. [But] Eli Lilly's drug is one of
the first steps that has been taken in what I feel is the right direction,
which is moving toward a preventive rather than a reactive
strategy."
Ruboxistaurin is an inhibitor of the enzyme called protein kinase C-beta.
It works by blocking one of the pathways by which sustained excess glucose
causes microvascular complications, including eye and kidney disease.
Ruboxistaurin is the first of a new class of agents being studied to treat
moderate to severe nonproliferative diabetic retinopathy. If approved, it
could be used to prevent or treat retinopathy, and possibly nephropathy and
neuropathy.
In an analysis of two 3-year, multicenter, randomized phase III clinical
trials, 32 mg/day of ruboxistaurin reduced the risk of sustained moderate
vision loss by 41% compared with placebo in patients with moderate to severe
nonproliferative diabetic retinopathy. Vision loss occurred in 6.1% of
patients treated with ruboxistaurin compared with 10.2% of patients treated
with placebo. Lloyd Aiello, MD, PhD, director of Beetham Eye Institute and
Section on Eye Research at Joslin Diabetes Center in Boston, presented this
data in June in an oral session at the American Diabetes Association's 66th
Scientific
Sessions.1
Diabetic retinopathy is the leading cause of blindness among adults. It
affects an estimated 4.1 million Americans >40 years of age, threatening
the vision of almost 900,000 people.
The first line of treatment for diabetes and its complications, including
diabetic retinopathy, is managing the diabetes. Tight control of blood glucose
and blood pressure has been shown to help prevent and slow the progression of
diabetic eye disease. Laser surgery can be used to treat some forms of
diabetic retinopathy. If the bleeding is severe, a patient may need a
vitrectomy to remove the vitreous gel.
"The future of diabetic retinopathy, in terms of stabilization and
even potential improvement of the retinopathy, is huge because they're working
on using these drugs in a stage before the proliferative disease
develops," Gonzalez says. 
References
1. Aiello LP, Vignati L, Sheetz MJ, et al.: Effect of ruboxistaurin
(RBX) on diabetic macular edema (DME) and visual loss: Meta-analysis of the
PKC-DRS and PKC-DRS2 (Abstract). Diabetes 55 (Suppl. 1):A54
, 2006.
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