New Drug for Diabetes-Induced Vision Loss TGA-Approved for Australian Patients

Australian patients with diabetes-induced eye disease can now access a new treatment option that provides consistent and continuous treatment with long-lasting effect.

The Therapeutic Goods Administration has now approved the drug ILUVIEN® (fluocinolone acetonide intravitreal implant), which delivers fluocinolone acetonide via a sustained release implant and provides therapeutic effect for up to 36 months.

It is available to people who have vision impairment associated with chronic diabetic macular oedema (DME), and who have been previously treated with a course of corticosteroids and who have not experienced a clinically significant rise in intra-ocular pressure (IOP).

ILUVIEN will be supplied throughout Australia by independent biopharmaceutical company Specialised Therapeutics (ST), under exclusive license from US-based Alimera Sciences, Inc (NASDAQ: ALIM).

ST Chief Executive Officer Mr Carlo Montagner said ILUVIEN was the company's first ophthalmology candidate in an expanding therapeutic portfolio.

"We are delighted to make this important new therapy available to Australian patients affected by DME, after successfully navigating what has been a complex regulatory process," he said. "Our commercial teams will now work to ensure that all appropriate patients can access this therapy at the earliest opportunity."

DME is a primary cause of vision loss associated with diabetic retinopathy. The disease affects the macula, which is the part of the retina responsible for central vision. Diabetic retinopathy causes swelling in the macula due to blood vessel leakage, which leads to DME. Onset of the condition is painless and may go undetected until it manifests as blurred central vision, or vision loss.

Alimera President and CEO Rick Eiswirth said ILUVIEN was the only treatment providing CONTINUOUS MICRODOSING(TM) technology, and has demonstrated the ability to reduce oedema in the retina for up to 36 months with one intra-ocular injection, thereby enabling patients to maintain vision longer with fewer injections.

"We are thrilled that ILUVIEN can now be accessed by Australian patients, following on from its approval in other key healthcare markets, including the United States, Europe and Canada," he said.

STA will seek to have ILUVIEN reimbursed via the Pharmaceutical Benefits Scheme.

About Specialised Therapeutics

Specialised Therapeutics is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout Australia as well as in New Zealand and Southeast Asia.

ST and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care. 

About ILUVIEN

ILUVIEN (fluocinolone acetonide intravitreal implant) delivers 0.19 mg fluocinolone acetonide via a sustained release intravitreal implant indicated to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing delivery is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat this persistent disease consistently every day. ILUVIEN is contraindicated in the presence of pre-existing glaucoma or active or suspected ocular or periocular infection. The most frequently reported adverse drug reactions included cataract operation, cataract and increased intraocular pressure.

About Diabetic Macular Oedema (DME)

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. Diabetic retinopathy causes swelling in the macula due to blood vessel leakage, which leads to DME. The onset of DME is painless and may go unreported 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.

About Alimera Sciences, Inc.

Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. 

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