US ophthalmic drug specialist Alimera Sciences (Nasdaq: ALIM) says that the US Food and Drug Administration has approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME).
The approval is for use in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Alimera currently intends to begin selling Iluvien Lin the U.S. in the first quarter of 2015. A single injection of the Iluvien micro-insert provides sustained treatment of DME for 36 months, according to the company.
Around 560,000 people in the USA are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries.
Approval triggers $25 million milestone for pSivida
FDA approval of Iluvien entitles development partner pSivida (Nasdaq: PSVD) to a $25 million milestone from its licensee Alimera Sciences. pSivida will also be entitled to 20% of the net profits from sales of Iluvien in the USA. pSivida’s shares rose 12.1$ to $4.81 in post-market trading.
“FDA approval of Iluvien, our third FDA-approved product for retinal disease, provides an important treatment option for DME patients in the USA, the majority of whose DME, despite anti-VEGF intra-ocular injections as frequently as monthly, is not optimally managed. Iluvien’s clinical trials showed that Iluvien can actually reverse vision loss in many DME patients. Another advantage of Iluvien over existing therapies is that a single injection provides sustained therapy for three years,” said Paul Ashton, president and chief executive of pSivida.
Milestone will finance other development programs
“The $25 million milestone will help finance our ongoing product development program, including Medidur for posterior uveitis and Tethadur for the sustained delivery of biologics,” added Dr Ashton.
pSivida is independently developing Medidur, an injectable, sustained release micro-insert of the same design and delivering the same drug as Iluvien, for the treatment of chronic posterior uveitis, the third largest cause of blindness in the USA. The company plans to seek FDA approval of this product on the basis of its ongoing single Phase III clinical trial. Enrollment of this study is expected to be completed by the end of the first quarter of calendar 2015.
Iluvien is already commercially available in the UK and Germany, and has received or is pending marketing approval in seventeen other European Union countries, for the treatment of patients with the chronic DME insufficiently responsive to available therapies.
“We are very pleased that the FDA’s approval of Iluvien is not limited, as in the EU, to the subset of patients with chronic DME, patients who have failed other therapies, or patients who have had cataract surgery,” continued Dr Ashton.
Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the United States to treat 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 most frequently reported adverse drug reactions included cataract development and increased ocular pressure.