Alcon, Lilly to co-market investigational diabetic retinopathy drug

Eli Lilly and Co. and Alcon Inc. have signed a long-term agreement to jointly market an investigational drug for diabetic retinopathy in the United States and Puerto Rico, the companies announced.

Under the terms of the agreement, Alcon will have primary responsibility for marketing Arxxant (ruboxistaurin mesylate) to eye specialists, including retinal specialists and general ophthalmologists. Eli Lilly will assume primary responsibility for marketing to endocrinologists and primary care physicians, according to a press release.

The agreement is subject to the drug’s approval by the Food and Drug Administration (FDA). Eli Lilly is seeking approval for treatment of moderate to severe nonproliferative diabetic retinopathy.

Phase 3 trial data show Arxxant reduces the risk of sustained moderate vision loss by 41% compared to placebo at 3 years follow-up. Researchers found that only 6.1% of Arxxant-treated patients suffered sustained moderate vision loss, compared to 10.2% of placebo-treated patients (P = .011), according to an Eli Lilly press release.

Sustained moderate vision loss was defined as a three-line reduction in visual acuity for at least 6 months.

The data involved 813 patients treated with either 32 mg/day of ruboxistaurin (412 patients) or placebo (401 patients) as part of two multicenter, randomized, controlled and double-masked trials. All patients had moderate to severe nonproliferative diabetic retinopathy at baseline.

A separate analysis involving 2,804 patients with type 1 or type 2 diabetes also showed the drug was generally well tolerated. Among patients with at least one diabetic microvascular complication, researchers found an overall adverse event profile similar to placebo.

Serious adverse events occurred in 23.2% of placebo patients compared to 20.8% of ruboxistaurin-treated patients, according to Eli Lilly. Ruboxistaurin also had no effect on glucose or blood pressure control, the company noted.

Under the new marketing agreement, if the drug is approved Alcon will make milestone and marketing payments to Lilly and Alcon will be compensated based on product sales.