The approval is based on data from two randomized, sham injection-controlled, double-masked phase 3 clinical trials with patient follow-up for 3 years.
The FDA has approved YUTIQ™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, announced the manufacturer, EyePoint Pharmaceuticals, Inc., in a press release. YUTIQ utilizes 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 intraocular pressure (IOP).
“Chronic non-infectious uveitis affecting the posterior segment of the eye is the third leading cause of blindness in the US,” said Nancy Lurker, EyePoint’s President and Chief Executive Officer. “We anticipate a product launch in the first quarter of calendar 2019 and look forward to bringing this innovative treatment to patients suffering from this disease.”
“The approval of YUTIQ is an advancement in the treatment of non-infectious 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 six and twelve-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. The approval of YUTIQ is an important step forward for patients and caregivers,” said Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine.
The FDA approved YUTIQ based on clinical data from two randomized, sham injection-controlled, double-masked Phase 3 clinical trials with patient follow-up continuing for three years. After six and 12 months, both clinical trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares. Although the p-value of less than 0.001 was reported in each clinical trial, the Company will be using a p-value of 0.01 which is reflected in YUTIQ’s label.
The first Phase 3 clinical trial met its primary efficacy endpoint at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 18.4% for YUTIQ versus 78.6% for control). This trial yielded similar efficacy through 12 months of follow-up (p < 0.01, intent-to-treat analysis; recurrence of 27.6% for YUTIQ versus 85.7% for control). YUTIQ was generally well tolerated through 12 months of follow-up with a mean IOP elevation of 1.3 mmHg compared to 0.2 mmHg in the sham. Cataract surgeries were performed in 33.3% of patients receiving YUTIQ compared to 4.8% for sham.
The second Phase 3 clinical trial also met its primary efficacy endpoint of prevention of recurrence of uveitis flares at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 21.8% for YUTIQ versus 53.8% for control). 12-month recurrence occurred in 32.7% of patients receiving YUTIQ and 59.6% of those receiving sham injection (p<0.01, intent-to-treat analysis). As observed in the first Phase 3 clinical trial, YUTIQ was well tolerated with a mean IOP elevation of 2.0 mmHg compared to no change in the sham. Cataract surgeries were performed in 18.0% of patients receiving YUTIQ compared to 8.6% for sham.
The 24-month and 36-month patient follow-up from the first Phase 3 clinical trial of YUTIQ is expected to be reported by the end of calendar 2018 and in the first half of calendar 2019, respectively.
EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg [press release]. Watertown, MA: Globe Newswire; October 15, 2018.