Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections

Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections

  • Lucentis recommended for approval in EU to treat patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia
  • Lucentis superior to current standard of care and improves mean visual acuity by around 14 letters at one year with a median of a total of two injections
  • Untreated, 90 % of patients with myopic choroidal neovascularization suffer severe visual loss

Basel, May 31, 2013 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis® (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).

CNV is the most common vision-threatening complication of high myopia[1]. Myopic CNV usually affects patients younger than 50 years old so any associated vision loss can have not only a significant impact on their quality of life but also on their productivity and to society[2]. In patients with untreated myopic CNV the long-term prognosis is poor with approximately 90% of affected patients developing severe vision loss after five years[3].

"Lucentis has already transformed the management of wet AMD, and we are very hopeful that if Lucentis receives approval in a fourth major ocular indication that patients with myopic CNV will benefit from this medicine," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Currently, all we hope to do for these patients is to stabilize vision and prevent further vision loss, so a treatment with the long-term safety profile of Lucentis that actually improves and maintains vision with just a few injections would be of great benefit."

The submission was supported by data from the Novartis-sponsored clinical trial, RADIANCE, that showed Lucentis provides superior improvement in visual acuity compared with the current licensed standard of care, Visudyne® (verteporfin PDT), in patients with myopic CNV. These new data showed around 40% of Lucentis treated patients compared with 15% of Visudyne treated patients gained 15 or more letters of visual acuity at month three[4]. Mean visual acuity gains of approximately 14 letters at one year were demonstrated with Lucentis; this was with a median of 2.0 injections.

In this pivotal Phase III study patients were randomized to one of three treatment arms: Lucentis treatment based on visual acuity stability (group 1) or disease activity (group 2); or Visudyne treatment (group 3). Subjects randomized to Visudyne could be given Lucentis after three months based on persistent disease activity. The primary endpoint was Lucentis superiority to Visudyne based on the mean visual acuity change from baseline to month three. Patients were followed for twelve months.

Both the Lucentis treatment groups were statistically superior (p<0.00001) to the Visudyne treatment group. Mean letter gains at month three from baseline in the two Lucentis groups (groups 1 and 2) were 12.1 and 12.5 letters, respectively, compared to a 1.4 letter gain in the Visudyne treatment arm (group 3). At twelve months, the mean letter gains from baseline were 13.8 (group 1), 14.4 (group 2) and 9.3 (group 3).

The safety profile of Lucentis was consistent with that observed in other studies as well as real-world experience and no new ocular/non-ocular safety risks were identified. The most common adverse events occurring in more than ten percent of patients, at twelve months, were conjunctival hemorrhage (ocular) and nasopharyngitis (non-ocular).

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. 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.

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 "recommended," "hopeful," "will," "hope," "would be," "could," 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; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; 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. Neelam K et al. Choroidal neovascularization in pathological myopia. Prog Retin Eye Res 2012;31:495-525.
2. Rose K et al. Quality of life in myopia. Br J Ophthalmol 2000;84:1031-1034.
3. Yoshida T et al. Myopic choroidal neovascularization: a 10-year follow-up. Ophthalmology 2003;110:1297-1305.
4. Wolf S et al. Ranibizumab vs verteporfin PDT for choroidal neovascularization secondary to pathologic myopia: a Phase III study. Asia Pacific Academy of Ophthalmology 2013.

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