Australian and New Zealand patients suffering from vision impairment due to a type of diabetes-induced eye disease will have access to a new treatment, following a license deal between Australian biopharmaceutical company Specialised Therapeutics Australia (STA) and Alimera Sciences (NASDAQ: ALIM).
The exclusive agreement enables STA to distribute ILUVIEN® (190 micrograms fluocinolone acetonide intravitreal implant in applicator) - a sustained release intravitreal implant used to treat vision impairment associated with chronic diabetic macular oedema (DMO), when the condition is deemed insufficiently responsive to current available therapies.
Under the terms of the license arrangement, STA will be responsible for all regulatory and commercial activities for ILUVIEN in Australia and New Zealand. The agreement includes a milestone payment to Alimera Sciences on achievement of a Pharmaceutical Benefits Scheme (PBS) listing, as well as an increasing royalty payment based upon a specific sales target.
Australian Ophthalmologist Professor Mark Gillies from the Department of Clinical Ophthalmology and Eye Health, University of Sydney, said ILUVIEN was a welcome treatment option for patients with DMO who no longer respond to conventional therapies and who face progression to loss of vision.
"ILUVIEN provides a new treatment option for those patients for whom other current therapies are unsuitable," Professor Gillies commented. "All people with diabetes, even those with well-managed conditions, face an increased risk of loss of vision from retinal disease."
"While there may be some side effects of ILUVIEN, these are treatable and a large clinical trial has demonstrated that many patients with advanced retinal disease will experience sustained improvement in their vision after receiving the implant in their eye which may last for up to three years. Some drugs that are currently injected into the eye may only last four weeks."
Each ILUVIEN implant provides a therapeutic effect for up to 36 months by delivering sustained sub-microgram levels of the corticosteroid, fluocinolone acetonide (FAc)1-3. ILUVIEN is injected into the back of the patient's eye to take advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound1.
DMO is a primary cause of vision loss associated with diabetic retinopathy. The disease 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 has progressed to DMO. Onset of the condition is painless and may go undetected until it manifests as blurred central vision, or vision loss.
STA Chief Executive Officer, Mr Carlo Montagner, said as the population of people with diabetes increases, it is anticipated the annual incidence of diagnosed DMO will also rise.
He said ILUVIEN was not yet approved for sale in Australia and New Zealand but would be made available to patients via the Special Access Scheme until it is approved by the Therapeutic Goods Administration (TGA) and Medsafe.
"We look forward to ILUVIEN providing benefit to thousands of diabetic patients who suffer vision impairment as a result of type 1 or type 2 diabetes," Mr Montagner said.
"We will seek regulatory approval from the TGA and Medsafe as well as reimbursement through the PBS to enable wider availability of this important ophthalmic treatment."
The National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK) has issued final guidance recommending ILUVIEN as an option for patients with chronic DMO.
President and Chief Executive Officer of Alimera Sciences, Mr Dan Myers, commented, "Not only does STA have a proven track record of successful product launches, STA has also consistently topped the IMS physicians surveys for having the most highly qualified and experienced sales force. We look forward to ILUVIEN making a difference to patients in Australia and New Zealand."
Specialised Therapeutics Australia