Lucentis Approved for Macular Degeneration

Lucentis is a genetically engineered drug derived from the cancer drug Avastin, which was the first targeted biologic treatment approved by the FDA.

The newer biologic was approved in June 2006 for the treatment of age-related macular degeneration, which is the leading cause of blindness in the elderly.

Bressler said the clear superiority of Lucentis with laser over laser alone in patients with diabetic macular edema should have an immediate impact on clinical practice, even though the biologic treatment is not approved for this indication.

“We expect the results of this study to have a major impact on how ophthalmologists treat macular edema in people with diabetes,” he says.

The study included 691 diabetic patients with macular edema in one or both eyes.

The patients received either standard laser treatment alone, Lucentis plus laser treatments in different dosing schedules, or the injectable steroid drug Trivaris with standard laser therapy.

Lucentis injections were limited to once a month, but most patients ended up having no more than eight or nine injections over the course of a year.

Few Complications, Better Outcomes

After one year, nearly 50% of the Lucentis-treated patients could read at least two additional lines on an eye chart or letters that were one-third smaller than could be recognized before treatment.

Vision loss, defined as loss of two or more lines on an eye chart, was seen in less than 5% of the patients treated with the biologic drug.

Patients treated with injections of the corticosteroid Trivaris and laser showed no greater improvement in vision than patients treated with laser alone.

These patients did have greater reduction in retina thickness, but they also experienced more treatment-related complications than other study participants.

About 30% developed potentially serious eye pressure requiring medication and 60% developed cataracts.

Few eye-related complications were reported in the Lucentis-treated patients, and these patients appeared to have no greater risk of heart attack or stroke.

Genentech: Long-Term Safety Unknown

The study results were published in the April 27 issue of Ophthalmology.

http://xml.apache.org/xalan">“These findings provide hope for a new treatment beyond laser for patients with diabetic macular edema, which may improve their chances of (maintaining) healthy vision,” says National Eye Institute (NEI) Clinical Director Frederick Ferris III, MD.

But a spokeswoman for Genentech tells WebMD the company has no plans to seek approval for Lucentis as a treatment for DME until its own phase III studies of the drug are complete.

Findings from two such studies are expected in the first half of 2011.

“While the results from this (newly published) study are very encouraging, we believe it is important to understand the long-term safety and efficacy of this drug and to study it in patients for longer than one year,” Nikki Levy of Genentech says.

It is also not clear if the company’s older and much cheaper biologic drug Avastin would be as effective as Lucentis for the treatment of diabetic macular edema, Ferris said. NEI is conducting a trial comparing Avastin to Lucentis in patients with age-related macular degeneration.

A dose of Lucentis costs about $2,000, compared to $50 to $200 for a dose of Avastin. Levy said the annual cost of Lucentis is about $15,500, assuming seven doses over the course of a year.