UK regulators have issued a green light for a new treatment that helps improve sight in diabetic patients with vision loss.
The Medicines and Healthcare products Regulatory Agency has now granted marketing authorisation for Alimera Science’s Iluvien to treat vision impairment as a result of chronic diabetic macular oedema (DME) in patients failing to respond to other therapies.
Iluvien is an intravitreal implant - inserted in the back of the patient's eye - that delivers tiny levels of the active substance fluocinolone acetonide for up to three years.
Its approval was based on clinical trial data showing that in patients with chronic DME at month 30, 38% experienced a significant improvement in their visual acuity after receiving Iluvien. And at the completion of the 36-month study, 34% achieved the same result, a “highly significant” difference compared to the control group, the firm said.
It is estimated that three million people in the UK have diabetes, of which nearly 200,000 suffer from vision loss associated with DME, highlighting the need for new and effective therapies.
"Iluvien addresses a significant unmet need by offering potential relief to patients who suffer from chronic DME and are insufficiently responsive to available therapies," said Andrew Lotery, professor of Ophthalmology at the University of Southampton, adding that its approval in the UK “means that thousands of people with diabetes facing the loss of their eyesight now have a sustained release pharmaceutical treatment option”.
All eyes will now be on the National Institute for Health and Clinical Excellence as to whether it will give its all-important seal of approval for the use of Iluvien on the National Health Service.