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FDA Approves Lucentis® (Ranibizumab Injection) For Treatment Of Diabetic Macular Edema (DME)

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.

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