Iluvien regulatory update

pSivida said the U.K.'s NICE rescheduled the second appraisal committee meeting to discuss chronic diabetic macular edema (DME) drug Iluvien fluocinolone acetonide intravitreal implant after the agency accepted additional data for review from a subgroup of DME patients. NICE issued draft guidance last month recommending against the use of Iluvien in the indication (see BioCentury, Aug. 13). pSivida said the data are related to a subgroup of pseudophakic patients - those who had already had cataract surgery and received an artificial lens when they were enrolled in the Phase III FAME trial. The new date is Oct. 11; it was Sept. 11. pSivida said that according to partner Alimera, the agency's committee needed "adequate time to thoroughly review" the data.

pSivida said partner Alimera determined that Iluvien was more cost effective in the subgroup because patients with artificial lenses cannot develop another cataract in the treated eye due to their exposure to the corticosteroid delivered by Iluvien. As a result, these patients will not experience a transient reduction in visual acuity due to cataract development, a problem that was seen in some patients during the first 2 years of FAME. pSivida added that pseudophakic patients will not incur the cost of cataract surgery. ...