Diabetic retinopathy blindness drug Iluvien (fluocinolone) improves vision: Alimera

Iluvien (fluocinolone) is inserted in the back of the patient’s eye with a device

Iluvien (fluocinolone), an investigational drug to treat blindness associated with diabetic macular edema by Alimera Sciences, Inc. has been found improving vision in clinical studies.

For the patients treated with the low dose of Iluvien, 26.8% to 30.6% demonstrated improvement in best corrected visual acuity (BCVA) of 15 letters from baseline, and for patients receiving the high dose of Iluvien, 26.0% to 31.2% demonstrated improvement of 15 or more letters in BCVA from baseline, both at 2 years, according to press release by Alimera.

Iluvien (fluocinolone) is an extended release intravitreal insert. Each Iluvien insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FA).

Iluvien is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics.

Iluvien is inserted with a device that employs a 25-gauge needle, which allows for a self-sealing wound.

Alimera’s 24-month FAME Study consisted of two Phase 3 pivotal clinical trials (Trial A and Trial B) for the use of Iluvien in the treatment of diabetic macular edema (DME).

Analysis Trial A data demonstrated statistical significance with 26.8% of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0%  of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline.

In Trial B, the vision improvement was even more – up by 30.6% of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 31.2%  of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline.

Data from a total of 956 patients from the randomised FAME trial were analysed.

Iluvien, both in low and high doses, showed greater numerical efficacy at month 24 than at month 18, a requirement for submission with 24 month data in the United States.

Alimera plans to seek approval of the low dose of Iluvien for the treatment of DME in the second quarter of 2010, followed by registration filings in various European countries and Canada.

Submission of Iluvien (fluocinolone) NDA will be based on the month 24 safety and efficacy data while the FAME Study will continue to month 36.

“If approved, we believe this [Iluvien] would be the first drug approved for the treatment of this [DME] condition,” stated Dan Myers, president and CEO of Alimera Sciences.

Diabetic macular edema or DME is the primary cause of vision loss associated with diabetic retinopathy. DME affects the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME.

The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision.

Over a 10-year period approximately 19% of diabetics studied were diagnosed with DME, according to the Wisconsin Epidemiologic Study of Diabetic Retinopathy.

Based on this study and the current U.S. diabetic population, there will be an incidence of approximately 340,000 cases of DME annually in the United States, Alimera estimates.

As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase as well.

Alimera Sciences is a biopharmaceutical company focused on diseases affecting the back of the eye, or retina.

Alimera has entered into agreements with Emory University, where by it acquired exclusive, worldwide rights under patent applications covering two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors.

Alimera’s initial focus is on the use of NADPH oxidase inhibitors in the treatment of the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy.

Alimera plans to evaluate the use of NADPH oxidase inhibitors in the treatment of other diseases of the eye, including the wet form of AMD and diabetic retinopathy.