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April 2011 Newsletter

Lucentis Retreatment Criteria In The EU

If one needs evidence that universal, government-run health care programs place their citizen's well-being at jeopardy, one need only turn to the package insert for Lucentis.

For the countries of the European Union the Lucentis package insert approved by the European Medicines Agency recommends an as-needed ("PRN") injection regime, and directs that retreatment should occur only after the patient has experienced a visual acuity loss of 5 letters or more.

In the United States optical coherence tomography (OCT) is commonly used to monitor lesion activity in neovascular AMD. Using OCT, PRN retreatment can be initiated at the first sign of exudation and visual improvement can usually be maintained.

There is little evidence to support the idea that vision lost to recurrent activity of choroidal neovascularization (CNV) can be fully regained. Lesion activity associated with visual loss is associated with progressive and irreversible photoreceptor damage, even if lesion activity can be suppressed again by renewed anti-VEGF treatment. Consequently, re-treatment should precede visual loss.

Because recurrent visual acuity loss is not fully reversible, a responsible attitude to retreatment of neovascular AMD must prioritize morphological criteria (such as OCT findings) over visual acuity criteria as they are currently defined by the European Union Lucentis label.

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Avastin Increases Risk Of Blood Clots

Researchers found that the incidence of arterial thromboembolic events (ATEs, "blood clots") in patients treated with Avastin (bevacizumab) was significantly higher than patients treated with Lucentis for neovascular AMD.

VEGF-A is believed to function as a homeostatic factor for blood pressure (BP), and inhibition of this function is thought to increase vascular tension. For example, systemic inhibition of VEGF-A has been associated with an increased risk of ATEs in colorectal cancer patients treated with intravenous Avastin.

The charts of 378 patients treated with at least 1 intravitreal injection of Lucentis or Avastin were reviewed to calculate the incidence of arterial thromboembolic events (ATEs). Only patients under monotherapy were analyzed.

The researchers found that ATEs occurred in 15 patients: 12 (12/97) with Avastin (12.4%) and 3 (3/219) with Lucentis (1.4%) - odds ratio 10.16. ATEs in the Avastin and Lucentis cohorts included stroke, myocardial infarction, angina pectoris, peripheral thromboembolic disease, transient ischemic attack, sudden death and lethal stroke.

The investigators conclude that Avastin raised the risk of ATEs when compared to Lucentis.

WHAT IT MEANS TO YOU: Avastin and Lucentis are very different molecules with similar pharmacologic effects. Avastin have a longer half-life, which means it sticks around in the body longer before being broken down and excreted. The longer half-life may mean that it has a higher propensity to cause unwanted side effects than Lucentis. We have seen signs of this in the eye, with more reports of severe inflammation and glaucoma associated with Avastin use compared to Lucentis. Because we do not yet have a study evaluating the two drugs head-to-head, we can't say if one drug is safer than the other. However, results from the ongoing CATT study may help shed some light on this question. Until then, recipients of off-label intravitreal Avastin should be informed for the higher potential of both ocular and systemic adverse effects compared to Lucentis.

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Omega-3 Fatty Acid And Fish Intake Prevents AMD

Dietary intake of omega-3 fatty acids and fish decreases the risk of early age-related macular degeneration (AMD) in women, according to a new study.

A detailed food-frequency questionnaire was completed by 38,000 female health professionals (mean age: 54.6 years) without AMD. A total of 235 cases of AMD were confirmed during an average of 10 years of follow-up.

Women in the highest tertile of intake for docosahexaenoic acid (DHA), compared with those in the lowest, had a multivariate-adjusted relative risk of AMD of 0.62. For eicosapentaenoic acid (EPA), women in the highest tertile of intake had a relative risk of 0.66. Women who consumed 1 or more servings of fish per week, compared with those who consumed less than 1 serving per month, had a relative risk of AMD of 0.58.

In this study regular consumption of DHA and EPA and fish was associated with a 35% to 45% lower risk of visually significant AMD during 10 years of follow-up. This inverse association was independent of other AMD risk factors. The study population comprised women without a prior diagnosis of AMD. Thus, these findings suggest that dietary intake of DHA and EPA and fish may be beneficial in the primary prevention of AMD.

In summary, regular consumption of DHA and EPA and fish significantly reduced the risk of incident AMD. This study is the strongest evidence to date to support a role for omega-3 long-chain fatty acids in the primary prevention of AMD.

WHAT IT MEANS TO YOU: DHA and EPA are the "active ingredients" of fish oil. This study finds that greater dietary intake of fish oil, or eating fish at least once per week, can help prevent the onset of AMD. This finding is significant because most research focuses on ways to slow the progression of AMD among those that already have the disease. We have much less information regarding what can help prevent the onset of AMD among normal health individuals. This study provides strong support for the practice of recommending fish oil supplementation and/or fish consumption as a means of avoiding AMD.

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Depression Increases Recurrence Of Central Serous Chorioretinopathy

A history of psychiatric illness is associated with an increased risk of recurrence of serous macular detachment in untreated patients with central serous chorioretinopathy (CSC), according to a new study.

Seventy-three patients were included in this retrospective review of untreated CSC patients. At baseline, the mean logMAR best corrected visual acuity (BCVA) was 0.30 logMAR. After a mean follow-up of 72 months, the mean final logMAR BCVA was 0.32 logMAR. The difference between the final and baseline BCVAs was not statistically significant.

At the last follow-up, 9 (12.3%) eyes showed improved vision of at least 2 lines, and 12 (16.4%) showed a worsening of at least 2 lines. During the study period, 38 (52.1%) patients experienced at least 1 episode of CSC recurrence. Multivariate Cox regression analysis showed that patients with a history of psychiatric illness (adjustment disorder and depression) were associated with an increased risk of CSC recurrence (hazard ratio = 3.5).

The investigators conclude that a history of psychiatric illness is associated with an increased risk of CSC recurrence.

WHAT IT MEANS TO YOU: It has long been recognized that CSC is associated with certain personality types - "Type-A", highly strung, highly stressed individuals. The results of this study are consistent with the view that CSC is associated with certain mental traits. It has been suggested that higher levels of endogenous steroids, such as cortisol, may be responsible for the observed association. Cortisol, often called "the stress hormone", is produced by the body in response to stress. Like all steroids, cortisol has been found to exacerbate CSC. However, the literature on depression and cortisol is mixed, with some studies finding an association between depression and elevated cortisol levels and others not. However, in light of this research it would be prudent for any person with a history of recurrent CSC to tightly manage depression and other psychiatric disorders.

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Lucentis Improves Vision In Diabetic Macular Edema

Genentech announced last month that a Phase III study evaluating monthly Lucentis (ranibizumab) 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 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.

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. Results from the RISE study will be presented at the Macula Society Meeting.

"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 Dr Hal Barron of Genentech.

Lucentis was recently approved for treatment of visual impairment due to DME in Europe. In the United States, Lucentis was approved for treatment of neovascular AMD in 2006 and for treatment of macular edema following retinal vein occlusion in 2010.

WHAT IT MEANS TO YOU: The treatment options for diabetic macular edema continues to grow. Anti-VEGF therapies appear to be very effective, but suffer from short-term benefit and the need for continual retreatment. Sustained release steroid implants (Iluvien) is another recent development for DME. The advantage Iluvien has over Lucentis is that it is administered as a 2-3 year intravitreal implant, rather than repeated intravitreal injections. On the downside, steroid therapy carries a risk of glaucoma and cataract. And there is still the laser photocoagulation option, which has a proven track record of stabilizing vision in patients with DME.

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Electroretinogram Responses To Lucentis Therapy Of Wet AMD

In patients with neovascular AMD retinal function, as measured using multifocal electroretinography (mfERG), improved following treatment with intravitreal Lucentis. The electroretinogram (ERG) is a recording of the electrical activity of the retinal cells located at the back of the eye when stimulated by light. Fifteen eyes with choroidal neovascularization due to AMD were studied with OCT and mfERG before, during and at the end of the treatment with Lucentis. This study's results showed a significant increase in the visual acuity and the retinal response density of the foveal area during treatment. The visual acuity and the mfERG retinal response density of the foveal area seemed to have little relationship with the foveal thickness measured using OCT. These findings may be explained by the fact that macular edema is only one parameter that can affect visual acuity. There are numerous other possible factors that can affect macular function, including the chronicity of the disease. mfERG results correlate better with visual acuity than foveal thickness measured with OCT. This study was published online in the journal Clinical and Experimental Optometry.

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Improving Intravitreal Injection Results

Use of smaller gauge needles and a beveled injection technique during intravitreal delivery of Avastin provides in superior results, according to a study published in the February edition of the Journal of Ocular Pharmacology and Therapeutics. This was a study conducted in 205 eyes of 205 patients. Intravitreal injection (IVT) of Avastin was performed with 6 types of needles and 5 techniques of scleral incision. The severity of subjectively evaluated pain (0-10) and the width of the subconjunctival bleb arising from the vitreal reflux were evaluated. The straight technique caused greater vitreal reflux than the beveled approaches. No difference in the severity of pain was found among all 5 types of incisions. There was greater reflux with larger (26- and 27-gauge) needles in comparison to smaller (29- and 30-gauge) needles; however, the width of the needle significantly affected the degree of reflux only when using the nonbeveled incision. The patients injected with the larger needles experienced more pain than those injected with smaller needles.

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Elevated Cholesterol And C-reactive Protein Associated With AMD

Patients with elevated concentration of plasma lipoproteins and C-reactive protein (CRP) have a higher risk of developing AMD, according to a study published in the February edition of Ophthalmic Research. This study involved 79 patients with AMD, average aged 71 years, and 84 aged-matched control subjects. The concentration of serum lipoproteins and C-reactive protein (CRP) were assessed in each patient. Statistical analysis of the data revealed significantly higher total, LDL, non-HDL cholesterol and CRP values in AMD patients compared to control subjects. The investigators conclude that that lipid status disorder and inflammation could play an important role in the development of AMD.

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NICE Rejects Lucentis For Diabetic Macular Edema

In draft guidance issued last month, the National Institute for Health and Clinical Excellence (NICE) in Britain has not recommended use of Lucentis for treating diabetic macular edema (DME). Commenting on the draft recommendations, Sir Andrew Dillon, Chief Executive at NICE said: "Although ranibizumab has been shown to be an effective treatment for DME... the Appraisal Committee was unable to recommend the drug for this condition because the economic analysis provided by the manufacturer did not reflect clinical practice in a number of respects." Lucentis costs 742 British Pounds per injection. Treatment is given monthly and continued until a patient achieves maximum vision. Treatment may then be resumed when monitoring indicates a loss of visual acuity. The Committee concluded that a more realistic analysis combining all of its preferred assumptions would be certain to produce cost-utility estimates that substantially exceeded the range it could consider to represent an effective use of NHS resources.

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