Article

NEW PRODUCT APPLICATIONS: Yutiq Implant for Chronic Noninfectious Posterior-Segment Uveitis

New uveitis treatment lasts longer, has fewer side effects.

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Chronic noninfectious intermediate, posterior, and panuveitis is the third leading cause of blindness in the United States. It affects between 55,000 to 120,000 people, resulting in approximately 30,000 cases of blindness annually.

The condition can be challenging to treat. “Many systemic medications are used to treat it, but none are universally effective, and their use may be complicated by systemic toxicity,” says Eric Suhler, MD, MPH, chief of ophthalmology at Portland VA Medical Center, and a professor of ophthalmology and public health at Oregon Health & Science University and OHSU-Portland State University of School of Public Health, which are both located in Portland, Oregon. Patients who progress to steroid-sparing therapy with systemic immune suppressants or biologics need to be monitored regularly and may experience systemic side effects, such as infections. For these reasons, local therapy may be preferred to systemic therapy for some patients.

Dr. Suhler, who has conducted clinical trials for the Yutiq fluocinolone acetonide implant (EyePoint Pharmaceuticals), says that currently available local therapies include injected corticosteroids, either with depot triamcinolone acetonide suspension or dexamethasone implant (Ozurdex; Allergan), which require a physician to administer them several times a year, or the surgically implanted Retisert (Bausch + Lomb), which has a longer duration of 2 to 3 years but requires an operation and can cause corticosteroid-associated intraocular pressure elevation and cataract formation. An ideal local intervention would last longer and would not present the risks of cataract formation and pressure elevation that are common side effects of local steroid therapies.

Yutiq injector.
IMAGE COURTESY OF EYEPOINT PHARMACEUTICALS, INC.

A NEW OPTION

EyePoint Pharmaceuticals’ Yutiq injectable implant should last about the same amount of time as the Retisert implant, and it uses the same corticosteroid found in Retisert at approximately one-third of the dose (0.18 mg vs 0.59 mg), Dr. Suhler says.1

Yutiq, which was FDA approved in October 2018, is supplied in a sterile single-dose preloaded applicator that is administered through an in-office procedure called pars plana intravitreal injection, says Dario Paggiarino, MD, chief medical officer of EyePoint Pharmaceuticals, Inc.

Yutiq is a nonbioerodible intravitreal microinsert that employs EyePoint Pharmaceuticals’ Durasert drug delivery technology. It allows for sustained-release delivery of small molecules for up to 3 years with a single local injection. The technology is already being used in 4 other FDA-approved products.

PROMISING OUTCOMES

The FDA granted approval to Yutiq based on clinical data from 2 randomized, sham injection-controlled, double-masked, phase 3 clinical trials with patient follow-up for 3 years, Dr. Paggiarino says. After 6 and 12 months, both clinical trials achieved the primary efficacy endpoint of preventing recurrent uveitis flares and demonstrated a P value of less than 0.01 between the treated and placebo groups.

Data from the 2 trials2 showed excellent evidence of effectiveness, with eyes implanted with Yutiq having significantly lower rates of inflammatory flares (37.2% at 1 year) than eyes that received sham injections (83.0% flaring at 1 year), Dr. Suhler says. As expected, cataract rates were higher in the treated group than the sham group, but pressure elevation in the 2 groups and rate of pressure-lowering surgery were similar based on 1-year results.

Data from Yutiq’s phase 3 clinical trials support that many patients achieved disease control without receiving additional treatment to control uveitis for more than 1 year,2 and when they do require additional treatment, they have fewer recurrences,3 Dr. Paggiarino says.

A BETTER ALTERNATIVE

The delivery of steroids locally in the eye eliminates the problem of systemic side effects from oral steroids. “The list of adverse side effects from oral steroids is quite lengthy,” says David Callanan, MD, partner at Texas Retina Associates in Dallas, Texas, who conducted clinical trials for Yutiq. Suppressing the immune system systemically can increase the risk of infection. Immunosuppressants also can cause adverse effects like fatigue or gastrointestinal issues.

“I had been looking for a product like Yutiq that is effective for a longer time with a lower adverse effect profile,” Dr. Callanan continues. “If you deliver steroids to the eye for a long enough period, most individuals will get a cataract, which is manageable. About one-third of patients who tried Yutiq in clinical trials needed cataract surgery, which is in the range of other short- to medium-duration products.4 The clinical trials of Yutiq showed that pressure increased in just 18% to 20% of patients.”4

“Patients with the Yutiq implant are more comfortable going back to their routine and not worrying about a flare-up,” Dr. Callanan says. “Any product that reduces inflammatory recurrences helps patients have a more normal life. They don’t have to take time off from work for doctors’ appointments and suffer for a few weeks until a flare-up is under control.” A smaller number of recurrence rates results in fewer secondary complications that can lead to vision loss. RP

REFERENCES

  1. Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection. Full Prescribing Information, October 2018.
  2. Suhler E. Fluocinolone acetonide intravitreal insert treatment for non-infectious posterior uveitis: 1-year pooled results. Paper presented at: the American Academy of Ophthalmology Annual Meeting; October 29, 2018; Chicago, Illinois.
  3. Nguyen QD. Controlling uveitic recurrences and avoiding cumulative damage. Results from a phase 3 study of 0.18 mg fluocinolone acetonide (Fai) in noninfectious posterior uveitis. Meeting of the American Society of Retina Specialists; July 25, 2018; Vancouver, BC, Canada.
  4. Cunningham Jr ET, de Smet MD, Yeh S, Albini TA, Zierhut M. Sustained-release corticosteroids for uveitis. Ocul Immunol Inflamm. 2015;23(6):421-424.