MONTREAL, Nov. 26, 2018 — Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, today announced that Health Canada has approved ILUVIEN® for the treatment of diabetic macular edema (DME). ILUVIEN is a fluocinolone acetonide sustained release non-biodegradable intravitreal implant used 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. Knight entered into an exclusive Canadian agreement for ILUVIEN with Alimera Sciences, Inc. (“Alimera”) in July 2015.
“The approval of ILUVIEN is great news for Canadian DME patients, payors and healthcare providers. ILUVIEN represents a well-studied, proven effective treatment for DME patients who can benefit from CONTINUOUS MICRODOSING without the burden of frequent injections,” said Jonathan Ross Goodman, CEO of Knight. “We are eager to work with all payors and stakeholders across Canada to make ILUVIEN available to Canadian patients.”
“We are excited that ILUVIEN has received approval by Health Canada,” said Dan Myers, CEO of Alimera. “ILUVIEN is the only treatment approved in Canada with CONTINUOUS MICRODOSING that can treat DME every day for up to three years with a single implant. We look forward to working with Knight to make ILUVIEN available to Canadian patients.”
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. and Canada 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, a corticosteroid, for 36 months to treat DME.
ILUVIEN has also received marketing authorization approvals in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. ILUVIEN is available commercially in the U.S., Germany, the U.K., Austria, Ireland, Portugal, Spain, Italy, and the U.A.E.
About Diabetic Macular Edema (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. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called 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. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight’s shares trade on TSX under the symbol GUD. For more information about Knight, please visit the company’s web site at www.gud-knight.com or www.sedar.com.
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.’s Annual Report and in Knight Therapeutics Inc.’s Annual Information Form for the year ended December 31, 2017. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.