Iluvien finds niche for treating DME
The low-dose fluocinolone acetonide-eluting device satisfies the need for an alternative to anti-VEGF and other corticosteroid injections.
Backed by solid clinical trial data, Iluvien has become an invaluable third-level treatment option for chronic diabetic macular edema, according to one clinician.
Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) is a non-bioerodible device designed to release fluocinolone acetonide at a rate of 0.25 µm per day for 36 months.
In September 2014, the FDA approved Iluvien for the treatment of DME in patients previously treated with corticosteroids who did not have a significant increase in IOP.
Iluvien was commercially launched in the U.S. on Feb. 23.
“We live in an era where there are more treatments than ever for DME, and we’re very fortunate,” Nancy Holekamp, MD, told Ocular Surgery News. “[Iluvien] is not first line. Anti-VEGF is first line. Corticosteroids are second line. Iluvien is a corticosteroid, but even then, a patient has to have prior corticosteroid exposure before receiving Iluvien. Because of its ability to deliver corticosteroid continuously over 3 years, Iluvien has its niche.”
Anti-VEGF therapy remains the primary treatment option for DME, Holekamp said.
“We live in the anti-VEGF era, and it’s well established that anti-VEGF therapy is the first line for center-involved diabetic macular edema,” she said.
In various anti-VEGF clinical trials, about 40% to 45% of eyes gained three or more lines of vision, Holekamp said.
“The flipside of that is about 55% to 60% of eyes are not achieving that gain, even with monthly anti-VEGF injections, as was done in the clinical trials or according to the DRCR protocol. We know that in the real world, people are getting far fewer injections than they did in those clinical trials. So, there’s a need for something above and beyond anti-VEGF therapy,” she said.
Some clinicians use off-label corticosteroids such as Triesence (triamcinolone acetonide suspension 40 mg/mL, Alcon) and Kenalog (triamcinolone acetonide, Bristol-Myers Squibb), Holekamp said.
Currently, there are two approved corticosteroids for DME: Iluvien and Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan). The FDA approved Ozurdex in June 2014 for the treatment of DME.
Iluvien may be a better option than other corticosteroids because it reduces the treatment burden for patients who do not respond to repeated anti-VEGF and only respond to repeated corticosteroid injections. Triesence and Kenalog last about 2 to 3 months, and Ozurdex lasts about 3 to 4 months, Holekamp said.
“If you find yourself giving these diabetic patients repeated corticosteroids injections, you might as well give them Iluvien because it’s one injection that lasts for 3 years,” she said. “Patients like it. They don’t want to have a needle stuck in their eye every time they come to the office.”
Holekamp noted that in the FAME study, no patients who met the current FDA label for Iluvien required incisional surgery to reduce IOP after Iluvien implantation.
However, DME patients who receive the implant should still have their IOP checked at least every 3 months, Holekamp said.
Although the Iluvien implant is not biodegradable and remains in the eye, patients do not see it, Holekamp said. Also, it is safe for patients to receive more than one implant.
“There has been some concern because the Iluvien implant is not biodegradable. It’s smaller than a grain of rice, but once you put it in the eye, it never goes away. It sits there permanently,” she said. “That’s OK because the material is the same material that is used for the haptics of some lens implants, and they stay in the eye permanently. So, there’s no trouble.”
Diabetes management plays a vital role in managing DME, Holekamp said. She cited results of the RIDE and RISE trials, in which patients who received extended DME treatment had stabilization of visual acuity. It is likely that they also gained better control of their diabetes during the 3-year studies.
“The patient, over time, gets their diabetes under better control because their vision is threatened, so for the first time in their life, they’re motivated,” Holekamp said.
However, the DRCR.net Protocol M study showed that intensive diabetes education and counseling did not improve HbA1c levels or blood sugar control at 1 year.
“I don’t think it’s a 1-year battle. I think it’s a 3-year battle,” Holekamp said. “That said, there are still going to be patients with chronic diabetic macular edema who have problems beyond 3 years. These patients are good candidates for Iluvien injections.” – by Matt Hasson
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- Nancy Holekamp, MD, can be reached at Pepose Vision Institute, 1815 Clarkson Road, Chesterfield, MO 63017; email: firstname.lastname@example.org.
Disclosure: Holekamp reports she is a consultant for Alimera Sciences, Allergan, Genentech and Regeneron.