PHARMACY

Clinical study finds Iluvien may improve conditions of diabetic macular edema

BY Alaric DeArment

ATLANTA An investigational drug for treating one of the main causes of blindness in diabetes patients improved patients’ best corrected visual acuity after two years, according to results of a two-trial clinical study.

Alimera Sciences announced Wednesday results of a phase 3 study of Iluvien (fluocinolone acetonide) in 1,900 patients with the diabetic macular edema, which is the primary cause of vision loss associated with diabetic retinopathy. The drug is delivered as an insert in the back of the patient’s eye to take advantage of the eye’s natural fluid dynamics.

In one trial, 26.8% of patients receiving a low dose of the drug had improvements in best corrected visual acuity, as measured by an ability to read at least 15 more letters on a vision-testing chart than before, as did 26% of those receiving the high dose. In the second trial, the figures were 30.6% for low-dose patients and 31.2% for high-dose patients.

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CDC director notes strong demand for H1N1 vaccination by consumers

BY Michael Johnsen

ATLANTA Now is the time for Americans to get their H1N1 vaccines, noted Anne Schuchat, director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, during a press conference with journalists last week. As of Dec. 12, “about 46 million people had been vaccinated with the H1N1 vaccine,” Schuchat said.

According to a CDC poll, about half of Americans have expressed interest in getting vaccinated, but only 1-in-3 have actually gotten the vaccine, suggesting that there still is a strong demand. More and more H1N1 vaccines have become available lately, including distribution through retail pharmacy channels.

Of the 46 million inoculation doses dispensed to date, 40% of those doses have gone to children, Schuchat said, though CDC estimates that 2 million children have received a recommended second vaccination. “We do think there are a lot of children that need their second dose in the weeks ahead,” she said.

CDC recommends that children get two doses of H1N1 vaccine, about four weeks apart.

H1N1 still dominates incidence of influenza, Schuchat noted, adding that while incidence of H1N1 is dropping, it’s still very prevalent. There are still 11 states reporting widespread activity, Schuchat added, and seasonal strains of influenza have yet to really predominate over H1N1.

The CDC consumer poll was conducted Dec. 6 through Dec. 12, and includes information culled from 1,368 adults and 3,243 children.

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Shire submits regulatory approval application for Fabry disease treatment

BY Alaric DeArment

CAMBRIDGE, Mass. Shire has submitted a regulatory approval application to the Food and Drug Administration for a biotech drug for treating a fatal genetic disease that affects approximately 10,000 people in the world, the company announced Tuesday.

The British drug maker is seeking approval for Replagal (agalsidase alfa), designed to treat Fabry disease. Fabry is a lysosomal storage disorder that causes deficiency of the enzyme alpha-galactosidase A, causing accumulation of the fatty substance Gb3 and resulting in symptoms such as cardiovascular and kidney dysfunction, pain, skin lesions and hearing and eye problems. The disease reduces the average patient’s lifespan by 15 to 20 years.

“We continue to deliver on our commitment to the Fabry community by filing a [biologics license application] to support long-term access to Replagal in the United States,” Shire Human Genetic Therapies president Sylvie Gregoire said. “We understand that this has been a difficult time for patients, and we remain committed to doing all we can to support the Fabry community during the supply shortage and for the long term.”

Replagal won approval in the European Union in 2001 and is available to Fabry patients in the United States under a limited FDA-approved treatment protocol.

In other news, Shire has also submitted approval applications in the United States, Canada and the European Union for velaglucerase alfa, a treatment for Gaucher disease, also a lysosomal disorder.

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