Hot Watch List (comments).
pSivida is a leader in the development of miniaturized, injectable, drug delivery systems. We develop products to treat serious or life threatening diseases alone or in partnership with other companies. We have developed devices that are so small they are FDA approved to be administered into the eye and once administered they release their drug for months and years.
pSivida’s lead development product, Iluvien™, delivers fluocinolone acetonide (FA). Formerly known as Medidur™ FA for DME, Iluvien is in fully recruited Phase III clinical trials for the treatment of diabetic macular edema (DME), one of the leading causes of blindness in the developed world. Iluvien is designed to provide sustained release of drug for up to three years after a single injection. It is also in Phase II clinical trials for the treatment of dry age-related macular degeneration (dry-AMD) and wet age- related macular degeneration (wet-AMD).
These studies are being conducted and fully funded by our licensee, Alimera Sciences (ALIM).
pSivida has licensed certain Medidur™ drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien™ and certain other ophthalmic products. Iluvien, fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), is pSivida’s lead development product and is in fully recruited Phase III clinical trials.
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 that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.
The NDA seeks approval to market ILUVIEN (fluocinolone acetonide intravitreal insert), an investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of DME. The ILUVIEN NDA was submitted to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA Priority Review status on August 30, 2010.
In the CRL, the FDA asked for analyses of safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of ILUVIEN. Alimera has completed month 36 of the FAME Study and has reported that it is preparing the analyses that the FDA has requested. Alimera further reported that it has requested a meeting with the FDA to clarify the path to regulatory approval. The FDA did not ask for any new clinical studies in the CRL.
In the CRL, the FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera reports it is in the process of compiling. Additionally, FDA indicated in the CRL that it had observed deficiencies in current good manufacturing practices (cGMP) during facility inspections of two of Alimera's third-party manufacturers, which were completed in August and September of 2010, and that all facilities and controls will need to comply with cGMP. Alimera reports that its third-party manufacturers are in the process of resolving these deficiencies.
Alimera Sciences to Hold Conference Call to Discuss Results From the Final Readout of the FAME(TM) Study of ILUVIEN(R)
ATLANTA, Jan. 27, 2011 Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it will release data from the final readout of the FAME Study after the market close on Thursday, February 3, 2011. The FAME Study consists of two 36-month Phase 3 pivotal clinical trials to assess the safety and efficacy of ILUVIEN(R) in the treatment of diabetic macular edema (DME).
So, this week we will know both safety and efficacy data through month 36 of the FAME Study. Exactly this data FDA asked in addition to those previously submitted in the NDA. If these data are impressive FDA should accept NDA. Other part of CRL (additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN) is also important but it needs a short time to resolve.
Disclosure: I opened both ALIM/PSDV positions today (short-term).
11.14.11 by BiotechInvest
FDA sent second CRL and crached both ALIM/PSDV to the ground.
"Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FAc), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose BCVA improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in September 2010 with the final patient visit at the three-year data point.
In February 2011, Alimera presented positive results from the full patient population.At month 36, the percentages of subjects with demonstrated improvement in BCVA of 15 letters or more from baseline were 28.4% and 29.0% for Trial A and Trial B respectively. Statistical significance was seen in both trials as late as month 33 with Trial A at 28.4% (p=0.042) and Trial B at 29.6% (p=0.046).
The FAME study results 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.
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.
The company said the Food and Drug Administration did not approve Iluvien because clinical trials of the drug did not prove it is safe and effective, and its benefits weren't strong enough to overcome its side effects, which can include cataracts and increased pressure inside the eye.
Iluvien is a tube that is injected into the eye and gradually releases a corticosteroid called fluocinolone acetonid.
The ALIM said it will request a meeting with the FDA to clarify its next steps. The company said it is considering its options in the U.S. and has funds to pursue approval in the European Union. It expects EU regulators to make a decision on the drug in in first half of 2012.
It seems like that FDA wants all new drugs and methods firstly to be tested on European patients.