Genentech's phase 3 data shows Lucentis improved vision in patients with macular degeneration

By Lisa Kerner

Erie, Pa., Jan. 17 - Genentech, Inc. announced positive one-year results from its second pivotal phase 3 study, known as Anchor, of the investigational drug Lucentis (ranibizumab) in patients with wet age-related macular degeneration, according to a company news release.

Lucentis, a humanized therapeutic antibody fragment developed at Genentech, is designed to bind and inhibit VEGF-A, a protein believed to play a critical role in the formation of new blood vessels.

The randomized, multi-center, double-masked, active-treatment controlled study compared Lucentis to verteporfin (Visudyne) photodynamic therapy in 423 patients with predominantly classic wet age-related macular degeneration.

Patients received intravitreal Lucentis injections (0.3 mg or 0.5 mg dose) once a month or photodynamic therapy every three months for two years.

Data from the Anchor study showed a difference in mean change in visual acuity of 18 letters for patients treated with 0.3 mg of Lucentis and 21 letters for patients treated with 0.5 mg of Lucentis from study entry compared to those treated with photodynamic therapy at 12 months.

Specifically, patients treated with Lucentis gained an average of 8.5 letters in the 0.3 mg dose group and 11 letters in the 0.5 mg dose group within the first year, compared to patients treated with photodynamic therapy, who lost an average of 9.5 letters.

In November, Genentech announced that the phase 3 Anchor study met its primary efficacy endpoint of maintaining vision (defined as a loss of less than 15 letters in visual acuity) in patients with wet age-related macular degeneration.

Adverse events were similar to those found in earlier trials of Lucentis. Common ocular mild to moderate adverse side effects included conjuctival hemorrhage, increased intraocular pressure, eye pain and vitreous floaters. Serious ocular adverse events included endophthalmitis and intraocular inflammation. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis (2.1%) than in the other two arms (0.7%).

Lucentis is being developed by Genentech and the Novartis Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains commercial rights in the United States and Canada, while Novartis has exclusive commercial rights for the rest of the world.

Age-related macular degeneration is a major cause of painless central visual loss and the leading

cause of blindness for people over the age of 60. It is estimated that by 2020, close to 3 million people in the United States will be afflicted with the condition, said the release.

In December, Genentech submitted a biologics license application to the U.S. Food and Drug Administration (FDA) for the use of Lucentis in the treatment of neovascular wet age-related macular degeneration. The submission included a request for priority (six-month) review based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal phase 3 trials, Anchor and Marina, and one-year clinical data from the phase 1/2 Focus trial.

In November, Genentech began enrollment in a phase 3b study, known as Sailor. The one-year study is designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for three months and thereafter as needed based on re-treatment criteria. The study will be conducted at more than 100 sites in the United States and will enroll up to 5,000 patients.

Genentech announced in July positive preliminary one-year results from the pivotal phase 3 Marina trial, a randomized, two-year, multi-center, double-masked, sham-injection controlled study evaluating the safety and efficacy of two different doses of Lucentis in 716 patients with minimally classic or occult wet age-related macular degeneration. Nearly 95% of patients treated with Lucentis maintained or improved vision at 12 months.

Genentech is also conducting Pier, a double-masked, sham injection-controlled study of the efficacy of Ranibizumab in subjects with subfoveal choroidal neovascularization, secondary to age-related macular degeneration. In this trial of 184 patients in the United States, Lucentis is administered once per month for the first three months followed by doses once every three months for a total of 24 months. Enrollment in this study is complete, with preliminary results expected in the second quarter.

Genentech is a South San Francisco, Calif. biotechnology company.

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