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FDA approves Lucentis for DME treatment

August 14, 2012

Genentech announced the approval of Lucentis® (ranibizumab injection) by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME). According to the Centers for Disease Control and Prevention, diabetes is now the leading cause of new cases of blindness in American adults, and DME is estimated to affect more than 560,000 Americans with the disease.


Lucentis is the first and only FDA-approved medicine for DME. To date, the standard of care in the United States for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.

“For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes.”

“This approval is an important advancement in the fight against blindness for people with diabetes,” said David M. Brown M.D., retinal specialist at The Methodist Hospital, Houston, Texas, and clinical trial investigator. “Now that it will be available, Lucentis therapy can begin to make a difference in the lives of our patients with DME.”

Lucentis 0.5 mg once monthly was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010. Lucentis 0.3 mg once monthly was approved for DME, and physicians can order immediately with shipments expected to begin Aug. 15.

Lucentis Efficacy in DME

The approval of Lucentis in DME was based on Genentech’s Phase III trials, RIDE and RISE, two identically-designed, parallel, double-masked, three-year clinical trials, which were sham-treatment controlled for 24 months. A total of 759 patients were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis (n=250), 0.5 mg Lucentis (n=252) or sham injection (control group, n=257). Primary outcomes were evaluated at 24 months and have been published in Ophthalmology.

In the studies, treatment with Lucentis demonstrated improved clinical outcomes including substantial visual gain for many DME patients. Results showed patients who received 0.3 mg Lucentis experienced significant, early (Day 7) and sustained (24 months) improvements in vision:

  • More patients who received Lucentis were able to read at least three additional lines (15 letters) on the eye chart at 24 months: RIDE: 34 percent in the 0.3 mg group versus 12 percent in the control group; RISE: 45 percent, 0.3 mg versus 18 percent, control (primary endpoint)
  • Patients who received Lucentis had average vision gains exceeding two lines (10 letters) on the eye chart at 24 months: RIDE: 10.9 letters, 0.3 mg versus 2.3 letters, control; RISE: 12.5 letters, 0.3 mg versus 2.6 letters, control
  • Significant gains in average vision were observed 7 days after the first treatment
  • Patients who received Lucentis were significantly more likely to maintain their vision (lose < 15 letters on the eye chart) at 24 months: RIDE: 98 percent, 0.3 mg versus 92 percent, control; RISE: 98 percent, 0.3 mg versus 90 percent, control

For all time points comparing 0.3 mg Lucentis to control through Month 24 p < 0.01.

Vision improvements observed in patients treated with Lucentis at 24 months were maintained with continued treatment through 36 months.

Lucentis Safety in DME

The benefit/risk profile of Lucentis was favorable in patients with DME through 36 months in the clinical trials. Pooled safety analysis of RIDE and RISE at 24 months showed:

  • The ocular safety of Lucentis in patients with DME was generally consistent with that established in patients with wet AMD and RVO (through 36 months).
  • The most common ocular events occurring at a higher rate in patients receiving 0.3 mg Lucentis compared to the control groups included conjunctival hemorrhage (bleeding under the lining of the eye): 47 percent, 0.3 mg versus 32 percent, control; eye pain: 17 percent, 0.3 mg versus 13 percent, control; foreign body sensation in eyes: 10 percent, 0.3 mg versus 5 percent, control; vitreous floaters: 10 percent, 0.3 mg versus 4 percent, control; and increased eye pressure: 18 percent, 0.3 mg versus 7 percent, control.

Although uncommon, trends toward increased rates of arteriothromboembolic events (ATEs) such as vascular death, deaths of unknown cause, nonfatal heart attacks and nonfatal strokes, have been observed in prior studies of Lucentis in other diseases.

  • Rates of these events were similar among DME patients receiving 0.3 mg Lucentis and the control groups at 24 months at 5.6 percent, 0.3 mg versus 5.2 percent, control. The rate of ATE events at 36 months was 10.8 percent for patients in the 0.3 mg treatment group (control period ended at 24 months).
  • The rate of stroke in DME patients at 24 months was 1.2 percent, 0.3 mg versus 1.6 percent, control. The rate of stroke at 36 months was 2.0 percent for patients in the 0.3 mg treatment group.

Pooled analyses also showed the rate of fatal events (death from any cause) in patients treated in the DME trials was low, and many causes of death were not unusual for patients with advanced diabetes complications. However, a potential relationship between the events and intravitreal use of VEGF inhibitors cannot be excluded. The rate of fatalities at 24 months was 2.8 percent, 0.3 mg versus 1.2 percent, control. The rate of fatalities at 36 months was 4.4 percent for patients in the 0.3 mg treatment group.

For additional safety information, visit http://www.lucentis.com for the Lucentis full prescribing information.

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