Novartis data at ARVO 2014 confirm transformational real world outcomes and highlight the safety profile of Lucentis® Freitag, 09. Mai 2014 - 07:17

• LUMINOUS, the largest ongoing trial in medical retina, presented 1-year results on the effectiveness and safety profile of Lucentis in patients with wet AMD[1]

• COMRADE-B study indicates BRVO patients treated with Lucentis had significantly higher vision gains at month 6 compared with dexamethasone[2]

• New real-world data demonstrates significant differences in rates of endophthalmitis with aflibercept and Lucentis[3]

Basel, May 9, 2014 - Novartis reports that considerable data on the eye drug Lucentis® (ranibizumab), first licensed in June 2006, have been presented at the 2014 Association for Research in Vision and Ophthalmology (ARVO) annual meeting this week. The work spans the five indications that Lucentis is licensed for (treatment of wet age-related macular degeneration (wet AMD), treatment of visual impairment due to diabetic macular edema (DME), branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and myopic choroidal neovascularization (myopic CNV)), and highlights the effectiveness and safety profile of Lucentis through both pivotal clinical trials and real-world observational studies. 

"Lucentis has already shown proven effectiveness in reducing vision loss across indications, and this is evident by the clinical trial findings presented at ARVO 2014," said Dr Timothy Wright, Global Head Development, Novartis Pharma AG. "What is key is that the efficacy and safety findings are also reflected in the real world clinical setting. The LUMINOUS 1-year interim results, for example, confirm the safety profile of Lucentis in patients with wet AMD."

Lucentis ARVO highlights include:

Real-world evidence: The LUMINOUS trial - the largest ongoing trial in medical retina to enroll 30,000 patients, is a 5-year prospective, multinational, observational study across all approved indications of Lucentis - presented 1-year results on the effectiveness and safety of Lucentis. Of the first 2,112 patients with wet AMD recruited, those prior treated patients, including those with more than 6 years of Lucentis treatment, maintained their vision in the first year of the LUMINOUS study. New Lucentis patients gained nearly a line of vision (+4.1 ETDRS letters from baseline). No new safety findings were identified[1]. [Paper session 335]  

Safety profile and efficacy: Results from the COMRADE-B study, which compared the efficacy and safety of Lucentis and dexamethasone in patients with BRVO, were reported. Patients treated with Lucentis (0.5 mg Lucentis intravitreal injections for 3 months followed by PRN dosing) compared to patients treated with dexamethasone (0.7mg implants for 6 months) had significantly higher vision gains at month 6. Both treatment groups exhibited low rates of ocular and non-ocular safety events, although there was a nine-fold higher incidence of increased intraocular pressure in the dexamethasone arm[2]. [Poster session 239]

Wet AMD: A retrospective cohort study of the injection number, associated costs and endophthalmitis rate in patients who received Lucentis or aflibercept for wet AMD in the US from November 2011 to July 2013 were reported. The US claims data showed that there was no significant difference between first-line Lucentis and aflibercept treatment for injection frequency (5.02 and 5.04, respectively), ophthalmologist visits (6.08 and 5.24, respectively) and annual costs (USD 9,894 and USD 10,288, respectively). However there was a significantly higher rate of endophthalmitis reported in association of aflibercept injections (0.17%) compared with Lucentis (0.08%), adjusted odds ratio=2.70[3]. [Poster session 507 - sponsored by Genentech]

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 age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME) and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO. Also, Lucentis is licensed in more than 60 countries, not including the US, for the treatment of patients with visual impairment due to choroidal neovascularization (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 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 2.4 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 words such as "indicates," "designed to," "goal," or similar terms, or by express or implied discussions regarding potential launches of Lucentis in additional markets, and potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Lucentis will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Lucentis will be commercially successful in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including ongoing pricing pressures; general economic and industry conditions; the company's ability to obtain or maintain proprietary intellectual property protection; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

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References

[1] Mitchell P. Ranibizumab in the real world clinical setting: results from the one year interim analysis of the LUMINOUS study. ARVO 2014.

[2] Hattenbach L-O. Efficacy and Safety of 0.5 mg Ranibizumab compared with 0.7 mg dexamethasone intravitreal implant in patients with branch retinal vein occlusion over 6 months: The COMRADE-B study. ARVO 2014.

[3] Kiss S, et al. Treatment Patterns and Associated Costs of Anti-VEGF Therapy for Neovascular Age-Related Macular Degeneration. ARVO 2014.

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