Clinical Trials

Date: 2015-11-16

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the American Academy of Ophthalmology Annual Meeting 2015 in Las Vegas

Company: Alimera Sciences (USA - GA)

Product: Iluvien®

Action mechanism:

corticosteroid. Iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant that releases sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic diabetic macular edema . The implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. Iluvien® is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.

Disease: diabetic macular edema

Therapeutic area: Ophtalmological diseases

Country:

Trial details:

The FAME Study consisted of two three-year, Phase 3 pivotal clinical trials, Trial A and Trial B, to assess the safety and efficacy of Iluvien® in the treatment of DME. Statistically significant differences between Iluvien®-treated eyes and sham-treated eyes were seen in both progression to PDR and the time to progression to PDR in both Trial A and Trial B. Patients in the FAME Study received a mean of 1.3 Iluvien® injections.

Latest news:

• On November 16, 2015, Alimera Sciences announced that a new analysis of patients from the FAME™ Study demonstrated a significant slowing of the progression of diabetic retinopathy (DR) in patients with diabetic macular edema (DME) treated with Iluvien®. "Analysis of Diabetic Retinopathy Progression in Patients Treated with 0.2 micrograms/day Fluocinolone Acetonide Over 36 Months" was presented by Charles C. Wykoff , M.D., Ph.D., Retina Consultants of Houston , as a Late Breaking Development during the Retina Subspecialty Day at the American Academy of Ophthalmology Annual Meeting 2015 in Las Vegas . In this analysis, continuous, low dose therapy with Iluvien® (0.2 micrograms/day Fluocinolone Acetonide) in the FAME Study was evaluated to determine its effect on progression to proliferative diabetic retinopathy (PDR), and the worsening of PDR, in DME patients. Along with the development of DME, these represent the most clinically significant measures of worsening of DR. At month 36, statistically significantly fewer Iluvien®-treated eyes experienced progression of PDR (17%) versus sham-treated eyes (31%) (p < 0.001). Progression of PDR in the FAME Study was determined based on fundus photographs that were graded by a masked, certified reading center, and by the incidence of the use of pan-retinal photocoagulation and the incidence of vitrectomy to treat PDR.