FDA OKs Fluocinolone Intravitreal Implant (Yutiq) for Uveitis

Megan Brooks

Disclosures

October 17, 2018

The US Food and Drug Administration (FDA) has approved fluocinolone acetonide intravitreal implant (Yutiq, EyePoint Pharmaceuticals) for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, the company has announced.

Yutiq contains 0.18 mg fluocinolone acetonide, which is released consistently over 36 months. It comes in a sterile single-dose preloaded applicator that can be administered in a physician's office.

Chronic noninfectious uveitis affecting the posterior segment of the eye is the third-leading cause of blindness in the United States.

Yutiq was evaluated in two randomized, sham injection-controlled, double-masked phase 3 clinical trials with patient follow-up continuing for 3 years.

The first trial met its primary efficacy endpoint of prevention of recurrence of uveitis flares at 6 months, which was significant (P < .01 intent-to-treat analysis; recurrence, 18.4% with Yutiq vs 78.6% with control), with similar efficacy seen through 12 months (P < .01 intent-to-treat analysis; recurrence, 27.6% vs 85.7%, respectively).

The second trial also met its primary efficacy endpoint of prevention of recurrence of uveitis flares at 6 months, which was significant (P < .01, intent-to-treat analysis; recurrence of 21.8% vs 53.8%) and at 12 months compared with sham injection (P < .01, intent-to-treat analysis; recurrence 32.7% vs 59.6%).

In both trials, Yutiq was generally well tolerated. The most common adverse reactions were cataract development and an increase in intraocular pressure.

The 24-month patient follow-up data from the first phase 3 clinical trial is expected to be reported by the end of this year and the 36-month follow-up data in the first half of 2019, the company said.

In a company news release, Glenn Jaffe, MD, professor of ophthalmology at Duke University School of Medicine, Durham, North Carolina, said: "The approval of Yutiq is an advancement in the treatment of noninfectious posterior segment uveitis, as it delivers consistent dosing without the peaks and valleys of current local corticosteroids, the standard of care."

"The clinical data have demonstrated that Yutiq has a meaningful effect to lower recurrence rates at 6 and 12 months following treatment. I believe the effect on recurrence rates will be highly beneficial to help to prevent secondary complications that can lead to vision loss," added Jaffe.

Yutiq is contraindicated in patients with known hypersensitivity to any components of the product, and in patients with active or suspected ocular or periocular infections, including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

The company expects to launch Yutiq in the first quarter of 2019.

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