New data for Novartis drug Lucentis® reinforces transformational efficacy and well-established safety profile across four indications

GlobeNewswire Europe

  • Pivotal myopic CNV trials with Lucentis® (ranibizumab) show visual acuity improvement of nearly 14 letters with a median of two injections at one year[1]
  • New data suggest early treatment initiation with Lucentis results in better vision gains in DME patients[2]
  • Meta-analysis of 14 trials and 6504 patients confirms well-established Lucentis safety profile reported from real-world experience and extensive clinical trials[3]

Basel, September 27, 2013 - New clinical and real world data for Lucentis® (ranibizumab) presented in over 40 abstracts at this week`s EURETINA congress confirm its transformational and well-established safety profile in four retinal diseases. Designed for intraocular use, Lucentis is an antibody fragment with a short systemic half-life and was first launched in Europe in 2007. Lucentis is now indicated in many countries for the treatment of wet age-related macular degeneration (wet AMD), for visual impairment due to diabetic macular edema (DME), macular edema secondary to branch- and central-retinal vein occlusion (BRVO and CRVO), and choroidal neovascularization secondary to pathologic myopia (myopic CNV).

"The abundance and quality of new data presented at EURETINA, in addition to the real-world long-term experience with Lucentis, speak to the importance of this anti-VEGF treatment for providing vision gains to patients and affirms its role as the standard of care in retinal medicine," said Dr Timothy Wright, Global Head Development, Novartis Pharmaceuticals. "Further to its transformational patient outcomes in wet AMD, DME, and RVO, Lucentis has now established its superior efficacy in myopic CNV compared with verteporfin photodynamic therapy as well."

Lucentis study highlights at the 13th European Society of Retina Specialists (EURETINA) Congress in Hamburg, Germany include:
Myopic CNV: In the RADIANCE global, Phase III, 12-month study, Lucentis was superior to current standard of care and improved mean visual acuity by around 14 letters at one year with a median of two injections[1]. [Free paper session 6] In REPAIR, a Phase II, 12-month study, a mean visual acuity gain of 13.8 letters from a low number of injections to month 12 (mean 3.6, median 3) was demonstrated. Myopic CNV patients treated with Lucentis experienced high overall treatment satisfaction as measured using the Macular Disease Treatment Satisfaction Questionnaire. The overall score increased from 55.0 at month 1 to 64.9 at month 12 (p = 0.0001)[4]. [Free paper session 6]

Safety profile of Lucentis: In a meta-analysis of 14 Phase II/III trials and 6504 patients across three Lucentis licensed indications - treatment of adults with wet AMD, visual impairment due to DME and visual impairment due to macular edema secondary to BRVO or CRVO - the safety profile of Lucentis was reported to be consistent with that from individual randomized, controlled clinical trials[3]. [Free paper session 6]

The overall baseline characteristics of the first cohort of wet AMD patients included in LUMINOUS, a global long-term study being conducted in the routine clinical practice setting, were as expected and are representative of patients from a real-world setting[5]. [Poster session]

DME: It was reported in the pivotal RESTORE trial that baseline visual acuity and duration of both diabetes and DME are strong predictors of best-corrected visual acuity (BCVA) changes over 36 months. Patients with a shorter duration of DME had better visual acuity outcomes, which highlights the requirement for prompt treatment initiation[2]. [Poster session]

The RELIGHT study demonstrated that switching to bimonthly follow-up after the initial dosing maintains improvements in vision. Median visual acuity gains of 5 letters, consistent with those from RESTORE and DRCR.net studies, were achieved with reduced monitoring frequency[6]. [Free paper session 6]

About Lucentis® (ranibizumab)
Lucentis was designed to save sight and has demonstrated transformational efficacy with individualized dosing in its licensed indications. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.

Lucentis is licensed in more than 100 countries, for the treatment of wet AMD, visual impairment due to DME and for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. Also, Lucentis is licensed in more than 30 countries for the treatment of patients with visual impairment due to CNV secondary to pathologic myopia (myopic CNV). In most 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.

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.

Novartis sponsors 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.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "suggest," "being conducted," "will," 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 131,000 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] Wolf S. RADIANCE: Ranibizumab versus verteporfin photodynamic therapy in the treatment of visual impairment due to myopic choroidal neovascularization. EURETINA 2013.
[2] Mitchell P et al. Baseline predictors of 3-year responses to ranibizumab and laser therapy in patients with visual impairment due to diabetic macular edema - the RESTORE study predictors analysis. EURETINA 2013.
[3] Korobelnik JF et al. Safety profile of intravitreal ranibizumab in age-related macular degeneration, diabetic macular edema and retinal vein occlusion: A meta-analysis of 14 phase II/III clinical trials. EURETINA 2013.
[4] Amoaku W et al. Impact of ranibizumab treatment on patient-reported outcomes for individuals with myopic choroidal neovascularization participating in the REPAIR study. EURETINA 2013.
[5] Holz F. LUMINOUS: Ranibizumab in routine clinical practice - baseline characteristics of the first cohort of patients from the prospective part of the multinational study. EURETINA 2013.
[6] Pearce I. RELIGHT- ranibizumab treatment of diabetic macular oedema (DMO) with bimonthly monitoring after initial treatment. EURETINA 2013.

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