The U.S. Food and Drug Administration (FDA) has approved dexamethasone intravitreal implant (OZURDEX®) at a dose of 0.7 mg for treating diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). OZURDEX® is a sustained-release biodegradable steroid implant that demonstrated long-term efficacy without the need for monthly injections. It is a prescription medicine that is an implant injected into the eye (vitreous).

DME currently impacts more than 560,000 Americans. It is an eye condition that can occur in people with diabetes (types 1 and 2) and causes fluid to leak into the part of the eye where focusing occurs (macula), causing blurred vision, vision loss and eventual blindness. The OZURDEX® implant uses the proprietary NOVADUR® solid polymer delivery system – a biodegradable implant that releases medicine over an extended period of time – to suppress inflammation, which plays a key role in the development of DME.

OZURDEX® is also used:

To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
To treat adults with non-infectious inflammation of the uvea (uveitis) affecting the back segment of the eye
To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).

Source: MarketWatch

Aflibercept (EYLEA) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.

EYLEA was approved in the United States for the treatment of wet Age-related Macular Degeneration (AMD) in 2011, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, and for DME in July 2014. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and the EU for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

About Diabetic Macular Edema (DME)

Diabetic Macular Edema (DME) or “swelling of the macula” is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.(1,2) Visual impairment due to DME is estimated to affect 3-4 percent of people with diabetes and is therefore the most frequent cause of blindness in young and middle-aged adults in most developed countries. As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow.

DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness. The macula is the part of the retina responsible for central fine vision.

Vascular endothelial growth factor (VEGF), a member of a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME. Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME, as well as the formation of new blood vessels (a process known as angiogenesis).

About EYLEA(R) (aflibercept) Injection for Intravitreal Injection

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. EYLEA is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. EYLEA helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.

Source: WSJ

The U.S. Food and Drug Administration (FDA) has approved aflibercept (EYLEA®) Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
 
“Diabetic macular edema is a leading cause of vision loss among working-age adults in the U.S., and we are pleased to be able to offer a new treatment option to these patients,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “Our clinical studies have demonstrated that treatment with EYLEA can help improve and maintain vision with every 8 week dosing after 5 initial monthly doses. EYLEA is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME.”
 
The approval of EYLEA in DME was based on the one-year data from the Phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared EYLEA 2 mg given monthly, EYLEA 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, after one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month EYLEA groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both EYLEA dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.
 

In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTA-DME and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
 

EYLEA is available as a single, 2-mg strength intravitreal injection for all approved indications. EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in 2011, and for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of Diabetic Macular Edema. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and EU for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).
 

About Diabetic Macular Edema (DME) 

Diabetic Macular Edema (DME) or “swelling of the macula” is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. It is estimated that of the 29.1 million American adults living with diabetes, 1.5 million have been diagnosed with DME, and approximately another million cases are undiagnosed.
 

DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes. This allows fluid from blood vessels to leak into the retina, causing macular swelling. Fluid in the macula can cause severe vision loss or blindness. The macula is the part of the retina responsible for central, fine vision.
 

Vascular endothelial growth factor (VEGF), a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME. Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME, as well as the formation of new blood vessels (a process known as angiogenesis).
 

About EYLEA® (aflibercept) Injection forvitreal Injection 

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. EYLEA is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in angiogenesis. EYLEA helps prevent VEGF-A and PlGF from interacting with their natural VEGF receptors as shown in preclinical studies.
 

Source: Yahoo

Aflibercept (EYLEA®) injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014.
 

“Diabetes is a growing health concern worldwide and this milestone brings us one step closer to being able to offer patients and physicians in the European Union a new therapeutic option for the treatment of diabetic macular edema,” said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.
 

The European Union (EU) submission is based on positive data from the Phase 3 VIVID-DME and VISTA-DME studies.
 

In the Phase 3 VIVID-DME and VISTA-DME trials, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) both achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. In these trials, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across the treatment groups and the laser control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.
 

One-year data from the VIVID-DME and VISTA-DME trials and two-year data from the VISTA-DME trial have been presented at medical congresses. Two-year data from the similarly designed VIVID-DME trial are expected later in 2014. Each of the VISTA-DME and the VIVID-DME trials is expected to continue as planned up to 148 weeks.
 

EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have been made in Japan, Asia Pacific, Latin America and the U.S., for the treatment of Diabetic Macular Edema. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Regulatory submissions have been made in the U.S. and the EU for EYLEA for the treatment of DME. A regulatory submission has been made in the U.S. for EYLEA for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO).
 

Source: MarketWatch

Swiss pharma giant Novartis AG announced that Lucentis (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: to treat patients with diabetic macular edema or DME, a main cause of vision loss among patients with diabetes. Laser therapy, the current standard of care in Japan, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve vision in Asian patients with visual impairment due to DME.
 
Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said: “Lucentis has previously been shown to be an effective treatment, improving vision loss and vision-related quality of life for patients with DME.” He continued, “Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications.”
 
The Lucentis approval as based on the REVEAL trial results, the first randomized study designed specifically to evaluate the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians.
 
At 12 months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. The safety results demonstrated that Lucentis was well tolerated in patients with DME both as monotherapy or when administered with laser.
 
Source: RTTNews

Figures showing that for the first time in more than half a century diabetic eye disease is no longer the leading cause of blindness in adults of working age have been welcomed by health authorities.
 
Public Health England says the fall can be partly attributed to better screening.
 
The figures are drawn from a study published in BMJ Open which examined the causes of blindness in people aged 16 to 64 living in England and Wales.
 
The study compared the number of people registered as blind in the year 2009 to 2010 with the same period 10 years earlier. This showed that inherited retinal disorders had overtaken diabetes as the main cause of blindness.
 
Changes over 10 years
 
Between 1st April 1999 and 31st March 2000 the 3 leading causes of blindness were:
 
• Diabetic retinopathy/maculopathy (17.7%)
• Inherited retinal disorders (15.8%)
• Optic atrophy (10.1%)
 
Between 1st April 2009 and 31st March 2010 the 3 leading causes of blindness were:
 
• Hereditary retinal disorders (20.2%)
• Diabetic retinopathy/maculopathy (14.4%)
• Optic atrophy (14.1%)
 
These figures are based on 1,756 registrations filed in 2009 to 2010 and 1,637 filed in 1999 to 2000.
 

Significant change
 
The research team, led by Moorfields Eye Hospital in London, say the figures represent a marked change in the main causes of blindness, as diabetes had been the main cause of blindness among working adults in England and Wales since at least 1963.
 
The authors say that falling rates of blindness caused by diabetes is significant because available data suggests that diabetes rates have risen over the last few decades. They conclude that a nationwide programme of eye checks for people with diabetes (diabetic retinopathy screening) introduced between 2003 and 2008 may be responsible for the fall.
 
However, the authors say these results are speculative and should be read with caution.
 
‘A key role’
 
Public Health England is more upbeat on the underlying factors and says screening has “played a key role”. In a statement, Dr Anne Mackie, director of programmes for the UK National Screening Committee, part of Public Health England, says: “Before the launch of the diabetic eye programme, less than half of the people with diabetes had regular eye screening. Even where they did, the quality of the test varied from one place to another and many developed serious eye problems that could have been prevented.
 
“2.5 million people are invited for diabetic retinopathy screening every year. Last year more than 74,000 were referred to hospital eye services for further investigation which led to around 4,600 people with diabetes receiving treatment to help prevent sight loss.”
 
‘More work needed’
 
Commenting on the study in a statement, Simon O’Neill, Diabetes UK director of health intelligence, says: “The fact that hereditary disorders are now the main cause of sight loss in the working age population is partly because these disorders are being better recognised and diagnosed, but it may also be partly because the Diabetic Eye Screening programme has played an important role in ensuring diabetes-related eye problems are being picked up earlier before they become sight threatening. This highlights why it is so important that everyone with diabetes gets an eye check at least once a year.
 
“But while this news is partly because of the good progress made in the last decade, it is important to emphasise that diabetes remains the leading cause of preventable sight loss in working age people and sadly every year there are still too many people with diabetes who are losing their sight unnecessarily. We know, for example, that many people are still not having their annual eye checks. Also, while the rate of blindness has reduced, the rising number of people with diabetes means the actual number of people with diabetes who lose their sight has stayed about the same so there is still much work that needs to be done.”
 

Source: WebMD
 
Research Source: BMJ Open