The FDA ( Food and Drug Administration ) has approved Lucentis ( Ranibizumab ) for the treatment of patients with neovascular ( wet ) age-related macular degeneration ( AMD ).

The FDA approval of Lucentis is based on data from two large Phase III clinical trials ( MARINA and ANCHOR ). In these studies:

Nearly all patients ( approximately 95 percent ) treated with Lucentis ( 0.5 mg ) maintained ( defined as the loss of less than 15 letters in visual acuity ) and up to 40 percent improved ( defined as the gain of 15 letters or more in visual acuity ) vision at one year, as measured on the Early Treatment of Diabetic Retinopathy ( ETDRS ) eye chart.

On average, patients treated with Lucentis in the MARINA study experienced an improvement from baseline of 6.6 letters at two years compared to a loss of 14.9 letters in the sham group.

In the ANCHOR study, patients treated with Lucentis, on average, experienced an 11.3 letter gain from baseline at one year compared to a loss of 9.5 letters in the Visudyne photodynamic therapy ( PDT ) control group.
Up to 40 percent of patients treated with Lucentis achieved vision of 20/40 or better.

Lucentis is contraindicated in patients with hypersensitivity and ocular or periocular infections. In clinical trials, the most common adverse reactions among patients treated with Lucentis ( reported in at least 6 percent more patients than in the control groups in at least one study ) included conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure and intraocular inflammation.

Although there was a low rate ( less than 4 percent ) of arterial thromboembolic events observed in the Lucentis clinical trials that was not statistically different between the Lucentis and control groups, there is a theoretical risk of arterial thromboembolic events following intravitreal use of inhibitors of VEGF.

Serious adverse events related to the injection procedure occurred in less than 0.1 percent of intravitreal injections, including endophthalmitis, retinal detachments and traumatic cataracts.

Other serious ocular adverse events observed among Lucentis-treated patients ( that occurred in less than 2 percent of patients ) included intraocular inflammation and increased intraocular pressure.

Lucentis is designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid causing rapid damage to the macula.

Age-related macular degeneration, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 55 years. Untreated, the majority of eyes affected with wet AMD may become functionally impaired. Wet AMD, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.

The vision loss in wet AMD is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision.

Source: FDA, 2006


XagenaMedicine2006