Genentech's one-year results from its second pivotal phase III study of the investigational drug Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD) were positive.

According to a Genentech release, data from the ANCHOR study comparing Lucentis to verteporfin (Visudyne) photodynamic therapy (PDT) 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 PDT at 12 months. In the first year of this two-year study, 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 compared to patients treated with PDT, who lost an average of 9.5 letters. In November 2005, the phase III 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 AMD.

"Lucentis is the first investigational therapy that has shown improved vision, not just a slowing of vision loss, in patients with all types of wet AMD. As a result, physicians may be one step closer to being able to set a new expectation for the future treatment of this condition," said Peter K. Kaiser, director, clinical research centre, The Cleveland Clinic Cole Eye Institute.

An analysis of the one-year data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common ocular adverse side effects occurred more frequently in the Lucentis arms than in the control group were mild to moderate and included conjuctival haemorrhage, increased intraocular pressure, eye pain and vitreous floaters. Serious ocular adverse events that occurred more frequently in the Lucentis-treated arms were uncommon and included endophthalmitis and intraocular inflammation (each reported in less than 1 per cent of patients per group). Among non-ocular serious adverse events, the frequency of cerebral vascular events was less than 1 per cent of patients per group. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis (2.1 per cent) than in the other two arms (0.7 per cent).

"Through the extensive clinical study program for Lucentis we have now shown a significant improvement in vision compared to Visudyne and in patients with all types of wet AMD. We look forward to working with the FDA on our BLA submission and priority review request. Given the existing unmet medical need for patients with wet AMD, we are providing access to Lucentis for eligible patients through SAILOR, a phase IIIb safety study," said Hal Barron, Genentech senior vice president, development and chief medical officer.

In December 2005, Genentech had submitted a biologics license application (BLA) to the US FDA for the use of Lucentis in the treatment of neovascular wet AMD. The BLA submission, which included a request for priority (six-month) review, is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal phase III trials, ANCHOR and MARINA, as well as one-year clinical data from the phase I/II FOCUS trial.

AMD is a major cause of painless central visual loss and is the leading cause of blindness for people over the age of 60. The National Eye Institute estimates that there are 1.6 million people with AMD in the United States alone and that this prevalence will grow to 2.95 million by 2020

Lucentis (ranibizumab) is a humanised therapeutic antibody fragment developed at Genentech and 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).

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercialises bio-therapeutics for significant unmet medical needs.