FDA grants Genentech priority review for Lucentis for macular degeneration

By Lisa Kerner

Erie, Pa., Feb. 28 - Genentech, Inc. said that the Food and Drug Administration has accepted the Biologics License Application for the use of Lucentis (ranibizumab) in the treatment of neovascular wet age-related macular degeneration, a major cause of painless central visual loss and the leading cause of blindness for people over the age of 60.

Lucentis, a humanized therapeutic antibody fragment, is designed to block new blood vessel growth and leakiness, which lead to wet age-related macular degeneration disease progression and vision loss, according to a company news release.

Genentech requested and was granted six-month Priority Review. The FDA grants Priority Review to products that are considered potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease.

The FDA has until the end of June 2006 to take action on the filing.

The Genentech application submission for Lucentis was based on one-year clinical efficacy and safety data from two pivotal phase 3 trials, Anchor and Marina, and one-year clinical data from the phase 1/2 Focus trial.

Data from these studies demonstrate that Lucentis is the first investigational therapy to have improved vision in patients with wet macular degeneration in two pivotal phase 3 clinical trials, the company said.

Lucentis is also the first investigational therapy to have demonstrated a clinical benefit compared to verteporfin (Visudyne) photodynamic therapy in a head-to-head clinical study (Anchor), according to the release.

Preliminary two-year data from the phase 3 Marina study showed that the improvement in the Lucentis groups at year one was maintained at year two as measured by visual acuity endpoints. There was further deterioration of vision among patients in the control group, Genentech said.

At least 90% of patients treated with Lucentis maintained or improved vision compared to approximately 53% of those treated in the control arm at year two.

"The FDA's decision to grant Priority Review underscores the potential significant advancement of Lucentis in the treatment of wet AMD and puts us one step closer to making available a therapy that may change outcomes for people with this devastating disease," senior vice president of development and chief medical officer Hal Barron, said in the release.

"The new two-year phase 3 Marina results provide us with additional important data from an ongoing rigorous clinical trial program that has consistently shown Lucentis improved or maintained vision for the majority of patients who otherwise may have faced blindness."

Genentech will submit two-year data from the phase 3 Marina study to the FDA and will also present the data during the Annual Meeting of the Association for Research in Vision and Ophthalmology in May.

In November, Genentech began enrollment in a phase 3b study (Sailor) of Lucentis for patients with all subtypes of new or recurrent active subfoveal wet age-related macular degeneration. 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. Up to 5,000 patients will be studied at more than 100 U.S. sites.

Genentech discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. The company is based in South San Francisco, Calif.

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