Date: 2012-09-05
Type of information: Presentation of results at a congress
phase:
Announcement: results presented at the 12th European Society of Retina Specialists (EURETINA) Congress in Milan, Italy
Company: Novartis (Switzerland)
Product: Lucentis® (ranibizumab)
Action
mechanism: Lucentis® is a recombinant humanized monoclonal antibody fragment (lacking a Fc region). Lucentis® is the first VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
In wet AMD, these new blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. Lucentis® administered monthly in wet AMD clinical trials demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.
In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula. Lucentis administered at 0.5 mg monthly in RVO clinical trials demonstrated the following average vision gains for patients at six months: Patients with branch-RVO experienced an average gain of 18.3 letters on the study eye chart (compared to 7.3 letters for the control group) and patients with central-RVO experienced an average gain of 14.9 letters on the study eye chart (compared to 0.8 letters for the control group).
Disease: wet age-related macular degeneration (wet AMD)
diabetic macular edema (DME)
visual impairment due to macular edema secondary to retinal vein occlusion (RVO)
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: Novartis has announced that new data for drug Lucentis® show that individualized treatment with Lucentis provides sustained improvement in vision with a low number of injections. It is estimated that over 80% of visual impairment is preventable when due to conditions such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO). These conditions can eventually lead to blindness if left untreated.
Lucentis® also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathological myopia (PM). Novartis will submit for regulatory approval in this indication in the European Union in the third quarter of this year and in Japan by the end of 2012.
Lucentis® study highlights at the 12th European Society of Retina Specialists (EURETINA) Congress in Milan, Italy include:
REPAIR
This one year study performed in twelve centers in the United Kingdom explored the efficacy and safety profile of 0.5 mg Lucentis® administered on an individualized basis in 65 patients with myopic CNV. After six months of treatment, mean visual acuity improved by twelve letters. Patients received an average of three Lucentis injections with 29 % requiring no further treatment beyond the first injection. This analysis shows that Lucentis therapy leads to improvement in visual acuity in patients with this condition. The six month interim results and the full one year data will be presented at Euretina. Currently, photodynamic therapy with Visudyne® (verteporfin) is the only approved medical treatment for this condition.
RESTORE
In the RESTORE extension study, 240 patients with DME received individualized treatment with Lucentis® according to a regimen consistent with the European Union label. Results showed that patients who were originally treated with Lucentis received an average of 13.9 injections over three years. 19-25% of patients across all study arms did not require any Lucentis injections during years two and three. An average of 3.7 injections in the second year and 2.7 in the third year were sufficient to fully maintain the mean of seven letters of visual acuity gained in the RESTORE core study. The safety profile was consistent with previous studies conducted in other indications. There were no cases of endophthalmitis reported within the RESTORE core and extension studies.
LUMINOUS
The Luminous program is one of the largest observational studies in ophthalmology and consists of two parts launched in 2011. The retrospective part comprises pooled data from four European registries of nearly 4,500 patients with wet AMD treated with Lucentis®. These data showed no new safety signals for Lucentis® and reinforces its well-characterized safety profile. The registries revealed low incidences of key adverse events at 12-months. Additionally, a low number of Lucentis injections were observed during the first year. The mean number of Lucentis® injections over twelve months ranged from 4.3 to 5.0 (based on all patients) and 4.7 to 5.5 (based on patients completing one year).
The prospective part of Luminous is expected to provide important long-term evidence on the real-world effectiveness and safety profile of Lucentis® in its licensed indications. This 5-year study is ongoing and currently has more than 5,500 patients enrolled. It is expected to recruit more than 30,000 patients from clinics across Asia, Australia, Europe, North and South America.
