Alimera Sciences, Inc. (Alimera), a pharmaceutical company that specializes in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, has signed an exclusive agreement with Knight Therapeutics Inc. (Knight), a leading Canadian specialty pharmaceutical company, for the distribution of Iluvien in Canada which is Alimera's sustained release intravitreal implant for the treatment of diabetic macular edema.
Under the terms of this agreement, Knight will also handle all regulatory and commercial activities for Iluvien in Canada. Iluvien currently is not approved for sale in Canada.
"We are excited to be working with Knight, which we believe is well-positioned to assist us in obtaining regulatory approval for Iluvien in Canada and subsequently launching the product there," said Dan Myers, president and chief executive officer of Alimera.
"They are adept at introducing innovative products to the Canadian market, and we look forward to developing a successful partnership."
It is estimated that there are more than two million Canadians who have diabetes, approximately 2.5 per cent of whom suffer from visual impairment due to diabetic macular edema.
"We are pleased to partner with Alimera to bring Iluvien to Canada," said Jonathan Ross Goodman, president and chief executive officer of Knight. "Iluvien is a unique product that addresses a clear unmet need for patients suffering from diabetic macular edema, and we are very excited about the prospect of making it available to Canadian patients."
Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the US to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each Iluvien implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
Corticosteroids have a history of effective use in treating ocular disease inflammation. Iluvien is injected in the back of the patient's eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, a phase 3 clinical study of Iluvien, the primary endpoint of improvement in vision of 15 letters or more was demonstrated at 24 months and the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
Iluvien is approved for marketing in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Kingdom, and the United States, and is commercially available in the United States, the United Kingdom, Germany and Portugal.