pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced month 36, top-line readout results for the FAME™ Study prepared by its licensee, Alimera Sciences, Inc. (Alimera).
Alimera previously presented the month 24, top-line results from the now completed FAME Study. The FAME Study consisted of two 3-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN in the treatment of DME. Patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups. Alimera presented data for both the low and high dose patient results at 24 months. Based on these data, Alimera submitted a New Drug Application (NDA) on June 29, 2010 for approval of only the low dose. Therefore, only the low dose data from the 36 month readout is being released by Alimera and is discussed in this release.
Alimera reported that data through month 36 for the Full Analysis Set in Trial A demonstrated statistically significant therapeutic effects of 28.9% at month 30.
Results from Trial B reported by Alimera were similar. Statistically significant therapeutic effects of 33.9% at month 30.
By comparison, in the month 24 data earlier reported by Alimera, 26.8% of ILUVIEN patients and 14.7% of control patients had gained 15 or more letters.
As reported by Alimera, Trial A and B data combined demonstrated a statistically significant effect at week three, and this effect was maintained throughout the 36 months. On a combined basis, 28.7% of ILUVIEN patients and 16.2% of control patients (p = 0.002) had an improvement in BCVA of 15 letters or greater over baseline at month 24, 31.4% versus 15.1% at month 30.
"We believe this data is very promising, and look forward to the response from the FDA. If approved, pSivida will be entitled to a $25.0 million milestone payment from Alimera and 20% of profits (as defined) on sales of ILUVIEN by Alimera," said Paul Ashton, president and CEO of pSivida.
The Full Analysis Set includes 376 patients in the ILUVIEN arm and 185 patients in the control arm with data imputation employed using last observation carried forward (LOCF) only for missing data. Data for the Full Analysis Set includes 190 patients in Trial A and 186 patients in Trial B randomized to the ILUVIEN arm.
Alimera reported safety data for all patients treated with ILUVIEN low dose and control group in the study. Increases in intraocular pressure (IOP) to 30 millimeters of mercury (mmHg) or greater at any time point were reported in 18.4% of the patients by month 36 compared to 16.3% by the month 24 readout. By month 36, 4.8% of patients had undergone an incisional surgical procedure to reduce elevated pressure versus 3.7% of patients by month 24. The incidence of cataract among patients with a natural lens in their eye at the start of the trial was 81.7% at month 36, with 80% undergoing a cataract operation, compared to 80% and 74.9%, respectively, by the time of the month 24 readout.
Alimera reported that the statistical significance observed in both trials at month 33 met the criteria for replication of two studies and that Alimera will provide the 36 month safety and efficacy data to the FDA in connection with the pending NDA for ILUVIEN.
Webcast slides prepared by Alimera containing more detailed information with respect to the 36 month data are being filed by pSivida with the Securities & Exchange Commission on Form 8-K. The information in this press release is qualified in its entirety by the more detailed information contained in those slides.