Novartis (NVS) Updates on Lucentis; Shows Encouraging Results in DME Patients
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Research on Novartis' (NYSE: NVS) Lucentis (ranibizumab) is highlighted in more than 200 abstracts this week at the 2012 Association for Research in Vision and Ophthalmology (ARVO) annual meeting. Lucentis research across multiple retinal disease areas continues to further advance our understanding of the long-term efficacy and safety profile of Lucentis as well as the benefits of an individualized treatment regimen.
“The research presented on Lucentis this week at ARVO highlights the benefit of an individualized approach to treating patients rather than a fixed, inflexible regimen,” said Tim Wright, Global Head of Development, Novartis Pharma. “With an individualized ‘as needed’ dosing regimen, the goal is for patients to achieve and maintain maximum vision gains without undergoing more injections than necessary, which brings benefit to the patient and economic value to the health system. Several studies presented at ARVO demonstrate how successful an individualized Lucentis treatment approach can be for patients with wet AMD and DME.”
Lucentis ARVO highlights include:
The RESTORE extension study: In RESTORE, patients with diabetic macular edema (DME) were treated with Lucentis 0.5 mg (monotherapy or combined with laser) or laser alone for a duration of 12 months. Lucentis-treated patients received a mean of seven injections and, on average, achieved a gain in vision of seven letters at one year. Of the 303 patients who completed the core RESTORE, 240 entered the extension study, all of whom were eligible for individualized treatment with Lucentis according to a regimen consistent with the European Union label. Results showed that an average of 3.7 injections in the second year and 2.7 in the third year of treatment were sufficient to fully maintain the mean visual acuity gained in the core study. The safety profile was consistent with previous studies across different indications. There were no cases of endophthalmitis reported through the RESTORE core and extension studies. [Paper session 4667]
Three Year Results of Visual Outcome with Disease-Activity-Guided Ranibizumab Algorithm for the Treatment of Exudative Age-Related Macular Degeneration: There were 316 wet AMD patients in a Swiss clinic evaluated following treatment with Lucentis 0.5 mg administered either monthly or quarterly on a pro re nata (PRN, or ‘as needed’) basis according to a disease-activity-guided monitoring and treatment algorithm. This independent, retrospective, interventional case series showed that at 36 months, patients had achieved a mean gain of approximately eight letters in visual acuity with a mean total of 16 Lucentis injections over the three years. [Poster session 438/D1115]
“The vision gains seen at the end of three years of Lucentis treatment in wet AMD patients were favorable and similar when compared to the pivotal Phase III trials — MARINA and ANCHOR” said Prof. Sebastian Wolf, University of Bern, Switzerland. “However the number of injections, a mean of 16 during three years, is significantly less than the monthly regimen used in those studies. This data confirms that an individualized treatment regimen, now standard of care in Europe, is best for patients.”
LUMINOUS: Data on nearly 4,500 patients with wet age related macular degeneration (AMD) treated with Lucentis were pooled for the retrospective part of Luminous, one of the largest observational studies in ophthalmology that is expected to provide additional long-term evidence on the effectiveness and safety profile of Lucentis in its licensed indications and real-world settings. The retrospective pooled analysis of European registries shows no new safety risks with Lucentis and confirmed its well characterized safety profile. The prospective arm of Luminous is ongoing and currently has more than 3,000 patients. It is expected to recruit more than 30,000 patients in all licensed indications from clinics across Asia, Australia, Europe, North and South America. [Poster session 2031/D1049].
“The research presented on Lucentis this week at ARVO highlights the benefit of an individualized approach to treating patients rather than a fixed, inflexible regimen,” said Tim Wright, Global Head of Development, Novartis Pharma. “With an individualized ‘as needed’ dosing regimen, the goal is for patients to achieve and maintain maximum vision gains without undergoing more injections than necessary, which brings benefit to the patient and economic value to the health system. Several studies presented at ARVO demonstrate how successful an individualized Lucentis treatment approach can be for patients with wet AMD and DME.”
Lucentis ARVO highlights include:
The RESTORE extension study: In RESTORE, patients with diabetic macular edema (DME) were treated with Lucentis 0.5 mg (monotherapy or combined with laser) or laser alone for a duration of 12 months. Lucentis-treated patients received a mean of seven injections and, on average, achieved a gain in vision of seven letters at one year. Of the 303 patients who completed the core RESTORE, 240 entered the extension study, all of whom were eligible for individualized treatment with Lucentis according to a regimen consistent with the European Union label. Results showed that an average of 3.7 injections in the second year and 2.7 in the third year of treatment were sufficient to fully maintain the mean visual acuity gained in the core study. The safety profile was consistent with previous studies across different indications. There were no cases of endophthalmitis reported through the RESTORE core and extension studies. [Paper session 4667]
Three Year Results of Visual Outcome with Disease-Activity-Guided Ranibizumab Algorithm for the Treatment of Exudative Age-Related Macular Degeneration: There were 316 wet AMD patients in a Swiss clinic evaluated following treatment with Lucentis 0.5 mg administered either monthly or quarterly on a pro re nata (PRN, or ‘as needed’) basis according to a disease-activity-guided monitoring and treatment algorithm. This independent, retrospective, interventional case series showed that at 36 months, patients had achieved a mean gain of approximately eight letters in visual acuity with a mean total of 16 Lucentis injections over the three years. [Poster session 438/D1115]
“The vision gains seen at the end of three years of Lucentis treatment in wet AMD patients were favorable and similar when compared to the pivotal Phase III trials — MARINA and ANCHOR” said Prof. Sebastian Wolf, University of Bern, Switzerland. “However the number of injections, a mean of 16 during three years, is significantly less than the monthly regimen used in those studies. This data confirms that an individualized treatment regimen, now standard of care in Europe, is best for patients.”
LUMINOUS: Data on nearly 4,500 patients with wet age related macular degeneration (AMD) treated with Lucentis were pooled for the retrospective part of Luminous, one of the largest observational studies in ophthalmology that is expected to provide additional long-term evidence on the effectiveness and safety profile of Lucentis in its licensed indications and real-world settings. The retrospective pooled analysis of European registries shows no new safety risks with Lucentis and confirmed its well characterized safety profile. The prospective arm of Luminous is ongoing and currently has more than 3,000 patients. It is expected to recruit more than 30,000 patients in all licensed indications from clinics across Asia, Australia, Europe, North and South America. [Poster session 2031/D1049].
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