FDA clears Roche eye drug
pharmafile | February 9, 2015 | News story | Sales and Marketing | AMD, DME, FDA, Lucentis, Retina, Roche, eyes, ranibizumab
The US Food and Drug Administration has shown Roche’s eye-condition drug Lucentis the green light to treat patients with diabetic retinopathy (DR) – damage to the retina caused by diabetes.
Lucentis (ranibizumab) is the first approved injection for the disease caused by diabetic macular edema (DME), the most common cause of visual loss which occurs when fluid deposits collect under the macula of the eye.
The treatment which was granted a breakthrough therapy designation by the FDA, works as a protein inhibitor, binding to molecules that are believed to play a critical role in the formation of new blood vessels.
“While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy,” comments Sandra Horning, who is the chief medical officer and head of global product development at Roche.
“With today’s approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”
Approval was based on the efficacy outcomes from a three-year study which included patients with baseline DR. Results demonstrated that a higher proportion of participants observed improvement of their disease compared to placebo treatment.
DME affects around 750,000 people in the US, it is caused by elevated blood sugar levels damaging the blood vessels of the retina which is the light-sensitive tissue at the back of the eye necessary for good vision.
The longer people have diabetes, especially if it is poorly managed, the higher their risk for developing DR. The eye disease is a leading cause of blindness in US adults under 55.
Aside from DR caused by DME, Lucentis is also approved for the treatment of wet age-related macular degeneration (AMD) – in which new tiny blood vessels grow from the blood vessels in the choroid – and macular edema following cataract surgery.
Tom Robinson
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