Basel, 14 February 2011
Lucentis Phase III study meets primary endpoint for improving vision in patients with diabetic macular edema (DME)
Patients with DME who received Lucentis were more likely to achieve a significant improvement in vision after 24 months compared to control group
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.
The study, known as RISE, showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group who received a placebo (sham) injection. BCVA is best-corrected visual acuity, the best possible vision a person can achieve with corrective lenses, as measured by reading the eye chart. A preliminary analysis of the data did not reveal any unexpected safety signals and further analyses are ongoing. Topline results from the RISE study will be presented at the 34th Annual Macula Society Meeting, on March 10, 2011 in Boca Raton, Florida.
“DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”
Lucentis was recently approved for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis. In the United States (U.S.), Lucentis was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006 and more recently for treatment of macular edema following retinal vein occlusion (RVO) in June 2010. RISE and RIDE are two identical, parallel confirmatory studies designed to support application to the U.S. Food & Drug Administration (FDA) for a potential new indication for Lucentis for DME.
About RISE (FVF4170g)
RISE is a multicenter, randomized, double-masked, sham injection-controlled, 36- month Phase III study designed to assess the safety and efficacy profile of Lucentis in 377 patients with DME. The primary endpoint compared the proportion of Lucentis and sham-treated patients who gained at least 15 letters in BCVA at month 24, relative to baseline. Patients were randomized to receive monthly injections of either 0.3 mg Lucentis (n=125), 0.5 mg Lucentis (n=125), or monthly sham injections (n=127). The study was not designed to compare the two doses of Lucentis, but each dose against the control group.
At three months, rescue laser treatment was made available to all patients, if needed based on pre-specified criteria. Laser treatment is the current standard of care for DME.
Secondary endpoints included other measures of visual acuity, need for laser treatments and changes in retinal anatomy. After month 24, patients in the control group are eligible to receive monthly injections of 0.5 mg Lucentis and all patients will continue to be followed for 36 months.
DME is swelling of the retina that occurs in people with diabetes, who suffer from a complication called diabetic retinopathy. Diabetic retinopathy is the most common diabetic eye disease and is characterized by damage to the blood vessels of the retina, the nerve layer at the back of the eye. 1 It can manifest in a number of ways. In DME, the damaged blood vessels leak fluid into the central portion of the retina, called the macula, causing it to swell. The macula is the part of the eye responsible for sharp central vision.1
Approximately 26 million people in the U.S. have diabetes and 1.9 million new cases are diagnosed in people aged 20 and older each year.2 Between 40 and 45 percent of Americans diagnosed with diabetes have some stage of diabetic retinopathy. 1 Up to 10 percent of all people with diabetes will develop DME during their lifetime and up to 75,000 new cases of DME are estimated to develop each year.3
The current standard of care for DME is laser surgery that helps seal the leaky blood vessels to slow the leakage of fluid and reduce the amount of fluid in the retina.1,4 According to the National Eye Institute (NEI), a patient may need multiple laser treatments to control the leaking fluid caused by DME.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the FDA for the treatment of neovascular (wet) age-related macular degeneration (AMD) in June 2006. Lucentis was also approved by the FDA for macular edema following retinal vein occlusion (RVO) on June 22, 2010.
Lucentis is designed to bind to and inhibit VEGF, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula, the portion of the eye responsible for fine, detailed central vision. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula.
In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.
In two Phase III clinical trials studying macular edema following RVO, both studies showed that Lucentis administered monthly demonstrated an early (day seven) and sustained vision improvement of three lines or more on the study eye chart during the six-month study.
Lucentis is a prescription medication given by injection into the eye, and it has side effects. Some Lucentis patients have had detached retinas and serious infections inside the eye. Lucentis should not be used in patients who have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.
Although not common, Lucentis patients have had eye- and non–eye-related blood clots (heart attacks, strokes and death). Some patients have increases in eye pressure within one hour of an injection.
Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure, such as developing a cataract. These can make a patient’s vision worse.
The most common side effects to the eye are increased redness in the whites of the eye, eye pain, small specks in vision and the feeling that something is in the eye. The most common non–eye-related side effects are nose and throat infections, headache and respiratory (lung) infections.
If a patient’s eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their eye doctor right away.
Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1 National Eye Institute. Health Information. Available at: http://www.nei.nih.gov/health/diabetic/retinopathy.asp.
2 American Diabetes Association. Statistics. Available at: http://www.diabetes.org/diabetes-statistics.jsp.
3 Ali, F.A. A review of diabetic macular edema. Digital Journal of Ophthalmology, vol. 3, no. 6, 1997. Available at: http://www.djo.harvard.edu/site.php?url=/physicians/oa/387.
4 Kamjoo, S. et al, New Therapeutic Approaches to DME, Advanced Ocular Care, Dec 2010, Available at: http://bmctoday.net/advancedocularcare/2010/12/article.asp?f=new-therapeutic-approaches-to-dme