New data for Novartis Lucentis confirms efficacy, safety profile of individualised treatment

New data for Novartis drug Lucentis (ranibizumab), the only anti-VEGF therapy licensed across three ocular indications, show that individualised treatment with Lucentis provides sustained improvement in vision with a low number of injections. It is estimated that over 80 per cent 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.

In a company release, Tim Wright, Global Head of Development, Novartis Pharma said, “Lucentis has become the standard of care in wet AMD and has helped to significantly improve vision in a majority of patients with this disease. These new data confirm that an individualised treatment approach can lead to optimal improvements in vision with a low average number of treatments, thus ensuring that patients with retinal diseases are not over- or under-treated. In addition, these data add to the well-characterised safety profile of Lucentis.”

Lucentis also demonstrated benefits in visual acuity outcomes in patients with visual impairment due to choroidal neovascularisation (CNV) secondary to pathological myopia (PM). Lucentis is currently not approved to treat this condition. 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.

The REPAIR study performed in 12 centres in the UK explored the efficacy and safety profile of 0.5 mg Lucentis administered on an individualised basis in 65 patients with myopic CNV. After six months of treatment, mean visual acuity improved by 12 letters. Patients received an average of three Lucentis injections with 29 per cent 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.

In the RESTORE extension study, 240 patients with DME received individualised 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 per cent 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.

“The results of this study show that individualised treatment with Lucentis can lead to a significant improvement in vision and that these improvements are sustained in the long term. It is important that we explore how these insights apply to real-world clinical practice to ensure that we are providing the best possible care for our patients,” said Professor Francesco Bandello, Department of Ophthalmology, Hospital San Raffaele, University Vita Salute San Raffaele, Milan, Italy and president elect of EURETINA.

The Luminous programme 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-characterised 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 five-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.

EP News Bureau