New Eli Lilly diabetic eye drug approved

Eli Lilly has announced that it has been granted approval for a new drug aimed for the treatment of a diabetic eye disease.

Arxxant, a ruboxistaurin mesylate, was approved by the FDA and is an investigational oral therapy used for the treatment of diabetic retinopathy.
This disease occurs when diabetes damages small blood vessels in the retina, which can lead to vision loss and in some cases blindness.

An approvable letter sent by the FDA to Eli Lilly asked for more data to support the clinical evidence currently offered by the company in support of the drug. The pharmaceutical states it will meet with the FDA to determine whether such a request can be granted.

Dr. Timothy R. Franson, vice president of global regulatory affairs, Eli Lilly and Company: “We will be working closely with the FDA to address issues outlined in the approvable letter and to define the pathway forward.”

Arxxant functions by limiting protein kinase C beta, which is linked to the development of diabetic retinopathy. Novartis states it is the first of a new class of drugs to be used for the treatment of non-proliferative diabetic retinopathy.

Analysts, such as Scott Henry at Oppenheimer, have suggested that the drug will now be delayed for approximately two years, since compound products normally will require two clinical trials before they are granted approval.

Occurring in around 4.1 million adults, diabetic retinopathy is the leading cause of blindness among adults of a working age. Around 899,000 adults over the age of 40 are affected by the disease in America alone.

© Adfero Ltd