Alimera predicts potential $2 billion global market for Iluvien brand

The Iluvien intravitreal implant will satisfy an unmet need among patients with diabetic macular edema and create sizeable new markets, Alimera Sciences officials said during a company-sponsored webcast.

Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg) is a non-bioerodable device designed to release fluocinolone acetonide at an initial 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, which was commercially launched in the U.S. on Feb. 23, is the only product of its kind, Dan Myers, president and CEO of Alimera, said.

“We are the only implant in the world that has this kind of long-term low-dose application,” Myers said.

The implant is approved in 16 European Union countries and is awaiting approval in Poland.

The Iluvien brand has a potential global market worth $2 billion, Myers said.

To date, Iluvien has been implanted in more than 1,500 eyes in the European Union, Myers said. He noted that, so far, only two patients who received the implant have required glaucoma surgery, attesting to the product’s safety profile.

Dave Holland, senior vice president of sales and marketing at Alimera, said that the number of DME patients with vision-threatening symptoms is expected to increase from about 575,000 in 2015 to about 646,000 in 2019.

Anti-VEGF agents, the current gold standard treatment for DME, typically do not yield expected visual outcomes, Holland said. For example, in the RIDE/RISE trials, 40% to 50% of patients treated with Lucentis (ranibizumab, Genentech) did not achieve visual acuity of 20/40, he said.

To fulfill the unmet need for a safe and effective treatment for DME, Alimera has created a senior sales and marketing team of 32 experienced representatives serving four regions and targeting about 2,500 retina specialists, Holland said.

Rick Eiswirth, chief operating officer and chief financial officer of Alimera, said that Medicare and private health insurance will reimburse patients and physicians for Iluvien.

“We’ve always felt very comfortable that Iluvien would be reimbursed pretty broadly and that’s because … it’s a significant unmet need,” Eiswirth said. “There’s a large number of patients out there that aren’t effectively treated with the current available therapies. We also believe that the pharmacoeconomic benefit is going to be a great opportunity for the insurance companies as well.”

Iluvien’s indication allows the agent to be used as a first-line therapy in the U.S., Eiswirth said.

“If you look at the cost of the other first-line therapies out there, the cost of Iluvien over 3 years vs. the cost of an anti-VEGF therapy or even Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) is much more cost-effective for the insurance companies,” he said.

Alimera officials expect 45% of reimbursement to come from Medicare, 45% from commercial carriers and the remainder from the Department of Veterans Affairs and Medicaid, Eiswirth said.

The cost of Iluvien is $8,800 per injection, Eiswirth said. Physicians will receive $473 per procedure, or $90 plus 4.5% of the cost of Iluvien. Physicians currently receive $142.50 for an average ranibizumab treatment, he noted.

Ken Green, PhD, chief scientific officer of Alimera, said that in two phase 3 clinical trials, Iluvien met the primary endpoint of the proportion of patients whose vision improved by 15 letters or more from baseline at 24 months. – by Matt Hasson

Disclosures: Alimera reports that Eiswirth is chief operating officer and chief financial officer, Ken Green is chief scientific officer, Holland is senior vice president of sales and marketing, and Myers is president and CEO.