Ruboxistaurin shows promise for patients with diabetic retinopathy

WASHINGTON — In two phase 3 trials, ruboxistaurin reduced the risk of sustained moderate vision loss by 41% when compared with placebo in patients with diabetic retinopathy, the drug’s developer said in a news release.

The phase 3, 3-year trials of Eli Lilly and Company’s Arxxant (ruboxistaurin) involved 813 patients treated with 32 mg per day of Arxxant (412 patients) or placebo. Patients had moderate to severe nonproliferative diabetic retinopathy at baseline.

Vision loss occurred in 6.1% of the Arxxant group, compared with 10.2% of those in the placebo arm, the release said. Over a 3-year period, that equates to a 41% relative risk reduction, the company said.

Analysis from 11 other studies found the drug had a similar adverse event profile as placebo. Indigestion — the only treatment-emergent adverse event — occurred with a frequency of at least 2%. This event was significantly more common in the treatment group than the placebo group.

According to the release, ruboxistaurin limits protein kinase C beta overactivation. It is the first of a new class of compounds being investigated for the treatment of diabetic retinopathy.

Arxxant was submitted for U.S. regulatory approval in February, and has received priority review status, the company said. The release noted the drug did not prevent disease progression to proliferative diabetic retinopathy.