“This is not your father’s steroid,” Alimera Sciences’ CEO Dan Myers told the Posterior Segment Company Showcase at OIS@AAO 2016 in discussing new evidence that the company’s lead product, Iluvien, has minimal effect on intraocular pressure (IOP) even though its active ingredient is fluocinolone acetonide. That should position the company well for 2017 when it will seek additional indications for the microdosing implant, Myers said.
He cited these follow-up data analyses of two large European trials that validated the minimal IOP side effects of Iluvien:
- Medisoft trial of 290 eyes that showed 6.6% of eyes had IOP >30 mm HG, 14.8% needed emergent IOP-lowering drops, and none had trabeculoplasty or incisional surgery.
- IRISS trial of 328 eyes that showed 8.2% had IOP >30 mm HG, 18.4% required emergent IOP therapy, and 0% and 0.6% required laser trabeculopalsty and incisional surgery, respectively.
Iluvien contains 190 μm of fluocinolone acetonide and releases 0.2 μm daily over three years. “This is by far the lowest dose of daily steroid over the longest period of time that’s available in ophthalmology,” Myers asserted. “As a result of that we think the mitigation of the IOP side effect is greatly reduced.”
He also added that in real-world experience, “the management of intraocular pressure is a much less concerning issue for physicians.”
Since the FDA approved Iluvien for treatment of diabetic macular edema in 2014, its market has grown significantly. Between the first and second quarters of this year, overall revenues increased 64% to $9.5 million.
Alimera has $42 million cash on hand and $35 million in outstanding debt, Myers said. “We think we have ample runway to achieve profitability in the first half of next year, when we’ll begin to look at expanded indications for Iluvien for retinal vein occlusion and nonproliferative diabetic retinopathy,” he said.
Under Dan’s leadership Alimera has commercially launched ILUVIEN®, Alimera’s lead product, in the US, UK, Germany and Portugal with Marketing Authorizations in an additional 14 countries throughout the EU.