A second Phase III clinical study of the investigational drug Lucentis ( Ranibizumab ) met its one-year primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration ( AMD ).

Approximately 94 percent of patients treated with 0.3 mg of Lucentis and 96 percent of those treated with 0.5 mg of Lucentis maintained vision ( defined as a loss of less than 15 letters in visual acuity ), or improved vision, compared to approximately 64 percent of those treated with Verteporfin ( Visudyne ) photodynamic therapy ( PDT ) ( p<0.0001 ) during the first year of the two-year study.

Patients treated with Lucentis had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry, an important secondary endpoint.
.
ANCHOR ( ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD ) is a Phase III randomized, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to PDT in 423 patients with predominantly classic wet AMD. Patients were randomized 2:1 to receive intravitreal Lucentis injections ( 0.3 mg or 0.5 mg dose ) once a month or PDT every three months for two years. Exclusion criteria included prior subfoveal laser treatment, PDT or experimental treatments for wet AMD.
Visual acuity was measured using the Early Treatment of Diabetic Retinopathy ( ETDRS ) chart, the standard method of quantifying visual acuity. The study is ongoing in the United States, Europe and Australia.

Preliminary safety findings were consistent with those observed in the other Phase III pivotal study of Lucentis, MARINA.
Common ocular adverse side effects that occurred more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain, increased intraocular pressure and vitreous floaters. Serious ocular adverse events that occurred more frequently in the Lucentis-treated arms were uncommon and included endophthalmitis ( approximately 1 percent ).
Among non-ocular serious adverse events, the frequency of cerebral vascular events was equal across all three arms. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis than in the other two arms, although this difference was not statistically significant.

Lucentis ( Ranibizumab ) is a humanized monoclonal antibody fragment designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis ( the formation of new blood vessels ). Consequently Lucentis blocks new blood vessel growth and leakiness which leads to wet AMD disease progression and vision loss.

Source: Novartis, 2005


XagenaMedicine2005