FDA Approves Lucentis

for the Treatment of Wet AMD

San Francisco, June 30, 2006 � The U.S. Food and Drug Administration (FDA) today approved Lucentis� (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Nearly all patients (95 percent) treated with Lucentis maintained their vision in Phase III clinical trials. Vision improved by a least three lines (or 15 letters) on the study eye chart in up to 40 percent of these patients at one year. Lucentis is designed to inhibit the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with this disease.

�Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients,� said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. �We are proud that the seminal work in angiogenesis conducted at Genentech, years of clinical study, and the dedication and commitment of thousands of patients and retina specialists have all contributed to this important approval.�

�In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD,� said Eugene de Juan, M.D., president, American Society of Retina Specialists. �We are pleased that Lucentis has been approved by the FDA and look forward to working with Genentech to provide retina specialists in the United States with access to Lucentis for patients as quickly and smoothly as possible.�

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.

In addition to data from the two pivotal studies, data from the Phase l/ll FOCUS and Phase lllb PIER studies were included in the FDA review.

Lucentis 0.5 mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections. Compared to continued monthly dosing, dosing every three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly.

�Now that Lucentis is approved, we will continue to work with the retina community to evaluate how patients may be able to benefit from less frequent dosing, as emerging clinical data indicate that dosing may need to be tailored to individual patient needs,� said Levinson.

In clinical trials, the most common adverse reactions among patients treated with Lucentis (reported in at least 6 percent more patients 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 (ATEs) observed in the Lucentis clinical trials that was not statistically different between the Lucentis and control groups, there is a theoretical risk of ATEs following intravitreal use of inhibitors of VEGF (Vascular Endothelial Growth Factor). Serious adverse events related to the injections 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 the Lucentis-treated patients (that occurred in less than 2 percent of patients) included intraocular inflammation and increased intraocular pressure. Lucentis is contraindicated in patients with hypersensitivity and ocular or periocular infections.

Vision Connection July 2006

Founded by Lighthouse International

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