Yutiq’s continuous dosing can help control inflammation.
No driver enjoys hitting a bump on a smooth road. Likewise, you don’t want your patient with posterior segment uveitis to encounter a “bump” in inflammation that may result in vision loss. Luckily, Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg (EyePoint Pharmaceuticals) can help avoid such impacts.
Commercially launched in the U.S. in February 2019, Yutiq received FDA approval in October 2018 for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which, according to Prevent Blindness, causes approximately 30,000 new cases of blindness each year in the United States.
The Yutiq microinsert uses EyePoint’s Durasert technology, which allows for sustained-release delivery of small molecules for up to three years with one injection.
Yutiq offers continuous dosing that avoids the peaks and valleys of local corticosteroids, says the company. Besides this smoother dosing, other benefits include few side effects and convenient administration.
As a general concept, “it’s better to have more persistent control of inflammation,” says Thomas Albini, MD, professor of clinical ophthalmology at Bascom Palmer Eye Institute, Miami, Fla. “Whenever you have a depot steroid, you run the risk of inflammation returning as the steroid wears off.” The sustained delivery available with Yutiq can reduce the recurrence of inflammation.
Each time a patient experiences an inflammatory uveitis flare, damage to the eye starts to accumulate, says David Callanan, MD, Texas Retina Associates, Dallas, Tex., and clinical professor at University of Texas Southwestern Medical Center. “At some point, there’s damage to the ocular structures,” he notes. “Even though you control the inflammation, some of that damage is permanent. So, we’ve always wanted a treatment for these patients that’s continuous and keeps them under good control over extended periods of time. The advantage of Yutiq is that it delivers steroid over an extended period of time, so one implant lasts a long period of time for the patient.”
Dr. Callanan used Yutiq as part of its clinical trial and estimates he has administered it to about 10 patients so far. Several were in the clinical trial when they received Yutiq and were stable for three years without any flare ups, he says.
Besides more continuous control, Yutiq is well tolerated. Dr. Callanan notes that he typically treats the majority of his posterior segment-involving uveitis patients with systemic agents. However, with Yutiq, “you don’t have to worry about systemic side effects; any side effects are limited to the eye.”
Yutiq showed itself to be well tolerated In two Phase 3 clinical trials. For instance, in the second Phase 3 trial, Yutiq had a mean IOP elevation of 2.0 mm Hg compared to no change in the sham trial. Cataract surgeries were performed in 18% of patients receiving Yutiq compared to 8.6% for sham.
Yutiq can be injected in the physician’s office, eliminating the need for a surgical procedure. Using a 25-gauge needle, the physician will “push the plunger, and the little pellet, smaller than a grain of rice, just drops into the eye and stays in the vitreous,” says Dr. Albini.
What’s more, most uveitis patients with posterior segment involvement tend to be working-age adults, notes Dr. Callanan. Every time they experience an inflammatory flare, they have to visit the office for an examination and possible change in treatment. “Being under good control for a long time helps them carry on with their normal lives,” he says.
While Yutiq represents an advance in poster uveitis treatment, some unknowns exist. One question relates to its potency. Dr. Albini isn’t certain in what percent of his patients Yutiq can be used as a standalone treatment. He thinks “It may wind up that a lot of patients may need Yutiq plus something else, or that maybe some of my patients will still need to use Retisert [Bausch + Lomb].” For his most severe cases, he expects that Retisert will be most useful. Dr. Albini is a consultant for both EyePoint and B + L.
Compared with a systemic agent, there’s a risk with Yutiq of cataract and elevated IOP, says Dr. Callanan, which will require monitoring.
Another question involves how many doses of Yutiq a patient can tolerate before a potential visual disturbance occurs, because the implant is not completely biodegradable. So far, this has not posed an issue for Dr. Callanan’s patients.
“When it comes to uveitis, every single patient is different, so just having a brand new treatment modality helps us a lot,” says Dr. Callanan. “It’s a matter of trial and error to find what’s the best treatment with the fewest side effects for that particular patient. So, giving us one more arrow in the quiver, so to speak, helps us tailor the treatment for each patient.” Or, in other words, minimize the bumps in the road. OM