Peak Efficacy of 33.6% of Patients in Trial A, (p< 0.001) and 42.4% of Patients in Trial B (p<0.001) Achieving Significant Visual Improvements Was Observed at Month 30 Among an Identifiable Subgroup. Statistical Significance Was Maintained Through Month 36
Alimera Plans to Submit This New Data to the
The FAME Study consisted of two three-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN® in the treatment of DME. The 956 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 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.
As previously reported, the pre-specified primary endpoint for the FAME Study was met for the low dose ILUVIEN in both Trial A and Trial B. Based on these data, Alimera submitted a New Drug Application (NDA) to the
Dr. Antoszyk's ARVO presentation today included additional data from a subgroup of study patients that was identifiable prior to administration of ILUVIEN. This subgroup reflected the duration of DME at baseline and across all patients randomized, with a median duration of DME at baseline of three years.
Of the patients diagnosed with DME for three years or more who were treated with ILUVIEN, 31.8% (p=0.010) in Trial A and 36.4% (p= 0.004) in Trial B experienced BCVA improvement of 15 letters or more from baseline at 36 months. Of the patients in the subgroup who received the control treatment, 13.6% in Trial A and 13.2% in Trial B experienced BCVA improvement of 15 letters or more from baseline at 36 months. Consistent with the full patient population, approximately 75% of the patients who were treated with ILUVIEN received only one ILUVIEN insert over the 36 month study. No statistical significance in BCVA improvement was found in the subgroup of patients with less than three years duration of DME.
"Throughout the FAME Study, ILUVIEN has shown significant potential for patients suffering with DME. This new data is particularly exciting with 34% of patients who've had DME for three years or more gaining three lines of vision after therapy," said Dr. Antoszyk. "If regulatory approval of ILUVIEN is obtained, we will be able to offer an additional option in the form of a long-term treatment to our patients who are dealing with this devastating disease."
Data for the subgroup was gathered from 536 patients who had been diagnosed with DME for three years or more and 416 patients who had been diagnosed with DME for less than three years. Alimera will provide these additional data in its response to the Complete Response Letter issued by the
Safety was assessed among those patients within the subgroup who were treated with ILUVIEN in the study. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 14.8% of these patients by month 36, compared to 18.3% in the full ILUVIEN treated patient population. By month 36, 5.3% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 86% at month 36, with 85% undergoing a cataract operation, compared to 80% and 74.9%, respectively, in the full patient population.
"We are pleased that this identifiable subgroup shows even greater benefit to risk than the full patient population through month 36 of the study, thereby further improving ILUVIEN's profile," said
About the FAME Study
Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across
Following its NDA submission to the
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
ILUVIEN is an investigational, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. ILUVIEN is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.
Forward Looking Statements
This press release contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's future results of operations and financial position, business strategy and plans and objectives of management for Alimera's future operations. Words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "contemplate," "predict," "project," "target," "likely," "potential," "continue," "will," "would," "should," "could," or the negative of these terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The events and circumstances reflected in Alimera's forward-looking statements may not occur and actual results could differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, delay in or failure to obtain regulatory approval of Alimera's product candidates, uncertainty as to Alimera's ability to commercialize, and market acceptance of, its product candidates, the extent of government regulations, uncertainty as to relationship between the benefits of Alimera's product candidates and the risks of their side-effect profiles, dependence on third-party manufacturers to manufacture Alimera's product candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited sales and marketing infrastructure, inability of Alimera's outside sales force to successfully sell and market ILUVIEN in the U.S. following regulatory approval and Alimera's ability to operate its business in compliance with the covenants and restrictions that it is subject to under its credit facility, as well as other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Alimera's annual report on Form 10-K for the year ended
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