Alimera Sciences, Inc, a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported top-line results from the month 24 readout of the FAME Study.

The FAME Study consists of two phase-3 pivotal clinical trials (Trial A and Trial B) for the use of Iluvien in the treatment of diabetic macular edema (DME). The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups.

The month 24 analysis using the Full Analysis Set in Trial A demonstrated statistical significance with 26.8 per cent (p value 0.029) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 26.0 per cent (p value of 0.034) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline. In Trial B, the month 24 data demonstrated statistical significance with 30.6 per cent (p value of 0.030) of the low dose patients having an improvement in BCVA of 15 letters or greater over baseline and 31.2 per cent (p value of 0.027) of the high dose patients having an improvement in BCVA of 15 letters or greater from baseline.

The Full Analysis Set includes all 956 patients randomized into the FAME Study, with data imputation employed using last observation carried forward (LOCF) for data missing because of patients who discontinued the trial or are unavailable for follow up.

In addition, both the low and high dose Iluvien showed greater numerical efficacy at month 24 than at month 18, a requirement for submission with 24 month data in the United States.

Safety was assessed for all patients treated in the study. Intraocular pressure (IOP) increases of 30 millimeters of mercury (mmHg) or greater at any time point, a key adverse event studied in the trial, were seen in 16.3 per cent of the low dose patients and 21.6 per cent of the high dose patients. Over the 24 month period, 2.1 per cent of patients receiving the low dose and 5.1 per cent of the patients receiving the high dose had undergone a trabeculectomy (filtration procedure) to reduce their eye pressure.

Based on these and other data, Alimera plans to seek approval of the low dose of Iluvien for the treatment of DME in the second quarter of 2010, followed by registration filings in various European countries and Canada. Submission of the NDA will be based on the month 24 safety and efficacy data while the FAME Study will continue to month 36.

“I am very proud of the Alimera team for having completed trials which we believe demonstrate efficacy at the month 24 clinical readout and am confident that we will submit an NDA application for Iluvien in 2010 for the treatment of DME. If approved, we believe this would be the first drug approved for the treatment of this condition,” said Dan Myers, president and CEO of Alimera Sciences. “Additionally, we appreciate the efforts of our clinical sites around the world that have managed and continue to manage the patients in the FAME Study.”

In addition to the analysis described above, as prospectively planned in the protocol, Alimera also conducted several other analyses of the 24 month data. These included a) an All Randomized and Treated (ART) analysis of the 24 month data that includes data from all subjects randomized and treated with values imputed for all missing data using the LOCF method, and b) a Modified ART analysis that utilizes the ART population, but excludes data collected subsequent to the use of treatments prohibited by protocol (such as intravitreal injections of Avastin, Lucentis or triamcinolone acetonide) with the last observation prior to protocol violation imputed to month 24 using the LOCF method.

The results of these separate analyses were as follows: by the ART analysis, in Trial A, 26.8 per cent of low dose patients and 26.2 per cent of high dose patients gained 15 or more letters at 24 months compared with 14.7 per cent of control patients (p = 0.029 and 0.032, respectively). In Trial B of the ART analysis, 31.3 per cent of high dose and 30.8 per cent of low dose patients gained 15 or more letters compared with 17.8 per cent of control patients (p = 0.028 and 0.026 respectively). The results for both doses in both trials were statistically significant. By the Modified ART method, in Trial A 22.6 per cent of patients in the low dose and 24.1 per cent of patients in the high dose gained 15 or more letters compared with 12.6 per cent of control patients (p = 0.057 and 0.026, respectively). Trial A was not statistically significant for either dose. In Trial B by Modified ART, 29.7 per cent of patients in the low dose and 29.3 per cent of patients in the high dose gained 15 or more letters compared with 13.3 per cent of control patients (p = 0.004 and 0.005, respectively). The results for both doses were statistically significant.

The FAME study protocol provides that the primary assessment of efficacy will be based on the Modified ART dataset and that the other datasets will be considered secondary; the protocol did not specify the Full Analysis Set as a dataset for analyzing the study. However, consistent with the US FDA-adopted International Conference on Harmonization guidance, it is anticipated that the US FDA will consider the Full Analysis Set to be the most relevant population for determining safety and efficacy in Trials A and B.

A more detailed analysis will be presented in February 2010 at the Angiogenesis, Exudation and Degeneration 2010 Meeting in Miami, Florida.