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Media releases

May 08, 2013 01:30 CET

Real-world data at ARVO highlight transformational outcomes seen with Lucentis®, including lower injection frequency than in original clinical trials

  • UK real world study shows 59% reduction of legal blindness attributable to wet AMD since introduction of Lucentis with 9.7 injections spread over 5 years
  • New one year REPAIR data shows visual acuity improvement of 14 letters with an average of 3.6 Lucentis injections in myopic CNV patients
  • Largest Lucentis meta-analysis, over 10,000 patients, confirms well-established safety profile reported from extensive clinical trials and real-world experience

Basel, May 8, 2013 - Novartis has reported that new data with the eye drug Lucentis® (ranibizumab), first licensed in June 2006, is highlighted in a total of 209 abstracts at the 2013 Association for Research in Vision and Ophthalmology (ARVO) annual meeting this week. This research across multiple retinal disease areas, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (CNV), demonstrates that Lucentis with a wealth of real world long term experience is the pioneering anti-VEGF ocular treatment with its transformational efficacy, individualized treatment regimen, and well established long-term safety profile.

"Lucentis was designed to save sight and this is further demonstrated by the wealth of data in multiple disease areas reported at ARVO this week. In patients with myopic CNV average VA gains were 14 letters with an average of 3.6 injections," said Dr Timothy Wright, Global Head Development, Novartis Pharma AG. "Real world evidence shows a lower number of injections and clinic visits than in the original studies with Lucentis, whilst achieving an over 50 percent reduction of blindness due to wet AMD."

Lucentis ARVO highlights include:
Real world evidence in wet AMD: One study looked at how Lucentis treatment impacted the rates of legal blindness secondary to wet AMD in Scotland, UK. Blind registration data from the Royal National Institute for the Blind was retrospectively analyzed. It was reported that since the commencement of treatment with Lucentis there was a 59% reduction in the incidence rate of legal blindness attributable to wet AMD. The mean number of clinic visits decreased by year, with 9.0 in year one, 5.8 in year two, 4.8 in year three, 2.3 in year four and 0.5 in year five; the average number of injections was 9.7 spread over 5 years. This study highlights how the transformational efficacy of Lucentis translates into clinical real-world practice[1]. [Oral session 118]

DME: The response rates were evaluated in patients with DME in the RESTORE trial. Patients were treated with Lucentis 0.5 mg (monotherapy or combined with laser) or laser alone for a duration of 12 months, at 12 months all patients were eligible for Lucentis 0.5mg as-needed and the study was extended to 36 months. The patients who responded better to Lucentis treatment were the ones who were more recently diagnosed with DME, highlighting the need for prompt therapy[2]. [Poster session 290]

Myopic CNV: In the prospective, multicenter trial of Lucentis in myopic CNV patients, the REPAIR study, the primary endpoint was the mean gain in letters from baseline visual acuity at 12 months. At month 12 the mean visual acuity gain was 13.8 letters, this was achieved with a low number of injections to month 12 (mean 3.6, median 3) with 21% patients requiring only the one baseline treatment[3]. [Poster session 314]

Safety profile of Lucentis: In the largest comprehensive evaluation of Lucentis safety data to date, a meta-analysis examining the systemic safety profile of Lucentis across 22 studies and 10,300 patients, the safety profile of was reported to be consistent with that from individual randomized, controlled clinical trials[4]. [Poster session 234]

LUMINOUS, a 5-year, global, prospective, observational, long-term study to evaluate the safety and effectiveness of Lucentis 0.5 mg across its licensed indications is being conducted. This global study, approximately 500 centers in 34 countries worldwide, aims to enroll 30,000 patients. The baseline characteristics of the first cohort of patients enrolled were as expected and are representative of patients from a real-world setting[5]. [Poster session 375]

About Lucentis® (ranibizumab)
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis was specifically designed for the eye, minimizing systemic exposure.

Lucentis is licensed for the treatment of wet AMD in more than 100 countries, in more than 90 countries for the treatment of visual impairment due to DME and in 90 countries for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. Novartis submitted regulatory approval for Lucentis for the treatment of myopic CNV in the European Union in the third quarter of 2012. In many countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

Novartis and Alcon sponsor the eXcellence in Ophthalmology Vision Award (XOVA). XOVA is an annual award launched in 2010 that provides funding to non-profit initiatives and projects that will have a positive impact on improving the quality of eye care and make a significant impact in addressing unmet needs in the fields of ophthalmology and optometry.

Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 1.7 million patient-treatment years of exposure since its launch in the United States in 2006.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "to evaluate," "aims" or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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References

[1] Cackett P et al. Intravitreal ranibizumab treatment of wet macular degeneration in SE Scotland - effect on blindness rates and 5 year follow up data. ARVO 2013.
[2] Mitchell P and Chong V. Baseline predictors of 3-year responses to ranibizumab and laser photocoagulation therapy in patients with visual impairment due to diabetic macular edema (DME): the RESTORE study. ARVO 2013.
[3] Yang Y. The REPAIR study: Prospective, multi-center trial of ranibizumab in choroidal neovascularization due to pathological myopia - the 12 month primary endpoint. ARVO 2013.
[4] Avery R et al. Meta-analysis examining the systemic safety profile of intravitreal ranibizumab injections in AMD, RVO and DME. ARVO 2013.
[5] Brand C. LUMINOUS: baseline characteristics of the first cohort of patients treated with ranibizumab 0.5 mg in routine clinical practice. ARVO 2013.

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