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New treatment for major cause of vision loss in diabetes more effective than current standard of care

Study shows ranibizumab significantly improves vision in patients with visual impairment due to diabetic macular edema compared to laser therapy alone

DORVAL, QC, June 7 /CNW Telbec/ - Results from a new major diabetes eye health study may have the potential to change the way vision loss due to diabetic macular edema (DME), a serious and devastating complication of diabetes, is treated(1). One year results from the RESTORE study show that 37 per cent of patients treated with ranibizumab only and 43 per cent of those treated with ranibizumab plus laser therapy, had a significant improvement in visual acuity of 10 letters or more on an eye chart, compared to 16 per cent of patients treated with laser alone - the current standard treatment for visual impairment due to DME.

These findings represent an important advancement in ophthalmology and add to the evidence that supports ranibizumab as the first treatment in 25 years to demonstrate benefit over the current standard of care for visual impairment caused by DME(2).

"The RESTORE results confirm what we've already seen in previous studies - the effectiveness of ranibizumab to rapidly improve visual acuity in patients with DME," says Dr. Peter Kertes, Retina Specialist at Sunnybrook Health Sciences Centre, Associate Professor of Ophthalmology and Vision Sciences at the University of Toronto, and clinical investigator at one of the seven Canadian trial sites involved in the RESTORE study. "The incidence of diabetes is on the rise and so are the long-term complications such as diabetic macular edema. These data reinforce that ranibizumab not only halts the progression of DME, but it is the first treatment that has been shown to improve vision in a meaningful way for patients with vision loss from DME, a benefit that may change the way this condition is treated."

Ranibizumab is approved in more than 80 countries, including Canada, for the treatment of wet age-related macular degeneration (AMD). It is not currently approved in any market for the treatment of visual impairment due to DME.

The RESTORE study

The randomized, double-masked, multicenter RESTORE study involved 345 DME patients with an average age of 63 years randomized into three treatment arms: ranibizumab 0.5 mg plus sham laser treatment, ranibizumab plus active laser treatment, and sham injection plus active laser treatment. The primary endpoint was the mean change in best corrected visual acuity (BCVA) from baseline to the average level from months one to 12. Key secondary endpoints were the mean change in BCVA over time, and safety.

The RESTORE study showed that over one year, patients treated with ranibizumab plus laser were able to read an additional 5.9 letters on a standard eye chart, while those treated with ranibizumab alone could read 6.1 letters more than at the start of the study. This compared with patients receiving laser therapy alone who could read an additional 0.8 letters. All figures are mean averages for the year. The study met its primary endpoint (both ranibizumab arms p(less than)0.0001 vs. laser alone).

The safety profile of ranibizumab in RESTORE was consistent with that previously observed in large controlled clinical trials, with no new safety risks observed. No cases of endophthalmitis were reported. Ranibizumab showed a low incidence (less than one per cent) of increased intra-ocular pressure (IOP). In terms of systemic safety, there was a low incidence of hypertension (five to eight per cent) and arterial thromboembolic events (three to four per cent) in all treatment groups

The results from RESTORE mirror a recent study conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) showing that after one year, nearly 50 per cent of eyes treated with ranibizumab and laser therapy demonstrated an improvement in vision of 10 letters or more on the eye chart, compared to 28 per cent with laser therapy alone(3).

Diabetes, diabetic retinopathy and diabetic macular edema (DME)

It is estimated that more than three million Canadians have diabetes(4), a disease associated with high levels of blood sugar which can damage many organs over time, including the eyes. Long-term diabetes can result in diabetic retinopathy, an eye disease characterized by changes in the blood vessels of the retina - the light-sensitive layer at the back of the eye.

Diabetic retinopathy is a leading cause of blindness in people under age 65, and almost all people with diabetes have some form of diabetic retinopathy(5).

While there are several forms of diabetic retinopathy, a number of people with the condition will develop DME, a serious eye condition which is caused by leakage of fluid in the central portion of the retina called the macula. The build-up of fluid causes swelling and thickening in the macula, distorting vision. Because this is the part of the eye responsible for sharp central vision, patients with visual impairment due to DME can find it hard to recognize faces and carry out everyday activities such as reading and driving. DME with visual impairment affects 1-3% of people with diabetes worldwide(6).

About ranibizumab

Ranibizumab is administered by intravitreal (in the eye) injection. Ranibizumab works by neutralizing a protein called vascular endothelial growth factor (VEGF), which is believed to cause abnormal blood vessel growth and leakage in the macula.

Ranibizumab is currently approved in Canada for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) and it is being explored for its potential in other ophthalmic diseases where there is an unmet medical need.

Ranibizumab was developed by Genentech and Novartis. Genentech has the commercial rights to ranibizumab in the United States, while Novartis has exclusive rights in the rest of the world.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "the first and only", "significant", "optimal", or similar expressions, or by express or implied discussions regarding potential new indications or labeling or regarding potential future revenues. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that ranibizumab will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that the drug will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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; 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 Pharmaceuticals Canada

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada Inc. conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, oncology, diabetes, cancer, ophthalmology and organ transplantation. In 2008, the Company invested close to $96 million in research and development. Novartis Pharmaceuticals Canada Inc. employs more than 750 people in Canada and its headquarters are located in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca<http://www.novartis.ca>.

 

References _____________________

(1) Lang, G. on behalf of the RESTORE study group. Safety and efficacy of ranibizumab as monotherapy or adjunctive to laser photocoagulation in diabetic macular edema: 12-month results of the RESTORE study. Late- breaker presentation at EASDec Meeting. May 22, 2010. (2) ETDRS Research Group (1985). Photocoagulation for diabetic macular edema. Archives of Ophthalmology 103: 1796-1806. (3) The Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmol 2010, in press. (4) Canadian Diabetes Association. Diabetes Fact Sheet. Located at: http://www.diabetes.ca/about-diabetes/what/facts/. Accessed on May 28, 2010. (5) Canadian Diabetes Association. Living with Diabetes: Vision health. Located at: www.diabetes.ca/about-diabetes/living/complications/vision-<http://www.diabetes.ca/about-diabetes/living/complications/vision-> health. Accessed on May 28, 2010. (6) Klein, R et al. (1984). The Wisconsin Epidemiologic Study of Diabetic Retinopathy: IV Diabetic Macular Edema. Ophthalmol 91:1464- 1474.

 

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For further information: Julie Holroyde, Hill and Knowlton Canada, (416) 413-4625, julie.holroyde@hillandknowlton.ca

Posted: June 2010

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