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Intravitreal drug delivery insert for DME proves safe, effective in phase 3 clinical trials
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WATERTOWN, Mass. — Iluvien for diabetic macular edema significantly improved visual acuity in two phase 3 pivotal clinical trials, manufacturer pSivida announced in a press release.
Alimera Sciences, pSivida's collaborative partner, plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration in the second quarter of 2010, according to a release from the company.
Iluvien is an extended-release intravitreal insert designed to deliver sustained sub-microgram therapeutic doses of fluocinolone acetonide for up to 36 months. The insert is injected into the eye with a 25-gauge needle.
The FAME (Fluocinolone acetonide in diabetic macular edema) study comprised two multicenter, randomized, double-masked clinical trials conducted in the U.S., Canada, Europe and India. The study included 956 patients randomized 2:2:1 to receive high-dose Iluvien (0.45 µg daily), a low-dose regimen (0.23 µg daily) or placebo. The primary efficacy endpoint was a change in percentage of patients whose ETDRS best corrected visual acuity improved by 15 letters or more at 24 months.
According to the Alimera Sciences release, 24-month data from trial A showed that 26.8% of patients receiving the low dose and 26% of those receiving the high dose had an improvement in BCVA of 15 letters or more. Both improvements were statistically significant (P = .029 and P = .034, respectively).
In trial B, 30.6% of low-dose patients and 31.2% of high-dose patients had an improvement in BCVA of 15 letters or more. These improvements were also statistically significant (P = .03 and P = .027, respectively).
Safety data showed that, overall, IOP increases to 30 mm Hg occurred in 21.6% of high-dose patients and 16.3% of low-dose patients. The results showed that 5.1% of high-dose patients and 2.1% of low-dose patients underwent trabeculectomy to reduce IOP during the 24-month period.
"We are very encouraged by these data and look forward to our collaborative partner Alimera filing the NDA for potentially the first ophthalmic drug therapy approved for DME," Paul Ashton, MD, pSivida president and CEO, said in the pSivida release.
The NDA submission will be based on 24-month safety and efficacy data. The FAME study is scheduled to proceed to 36 months.