Posted by Michael Wonder on 15 Oct 2018
EyePoint Pharmaceuticals receives FDA approval of Yutiq (fluocinolone acetonide 0.18 mg intravitreal implant)
15 October 2018 - The first long-lasting, FDA approved micro-insert for up to three years of continuous control in chronic, non-infectious posterior segment uveitis, the third leading cause of blindness in the U.S.
EyePoint Pharmaceuticals announced today that the U. S. FDA has approved Yutiq (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Yutiq utilises the Company’s Durasert drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months.
Yutiq is supplied in a sterile single-dose preloaded applicator that can be administered in the physician’s office. In clinical trials, Yutiq significantly reduced the rate of recurrent uveitis flares versus sham, and the most common adverse reactions reported were cataract development and increase in intra-ocular pressure.
