Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, resubmitted a new drug application (NDA) to the Food & Drug Administration. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.
The companies received a rejection letter from the FDA for the drug-device combination last December. The new application, submitted 11 months after the companies’ first NDA, addressed questions raised in the agency’s rejection, also known as a complete response letter (CRL), pSivida said. The FDA requested additional analysis of safety and efficacy data from the companies’ FAME study along with additional information on specifications on the manufacturing, packaging and sterilization of the drug by third-party manufacturers, the pSivida said.
"We believe the additional data we recently released will help the FDA further evaluate the safety and efficacy of Iluvien. In addition, the third-party manufacturing deficiencies identified in the CRL have been resolved and this information, along with the new safety and efficacy data, [was] included in our response to the FDA’s CRL…" in remarks that Alimera CEO Dan Myers prepared for the company’s first quarter earnings report.
pSivida expects the resubmission to be completed within a six months.
Alimera, which went public one year ago, currently has no revenues. The company reported losses of $4.7 million, or 15 cents per diluted share, for the three months ended March 31. Operations accounted for $4.4 million of those losses. For the same period last year, Alimera had comparable operating expenses of $4.2 million, but for 2011, the company allocated funding from research & development to general and marketing expenses. The increases were “primarily due to pre-marketing expenditures related to the commercial launch of Iluvien,” which was previously expected in the first half of 2011, the company said in its earnings statement.
pSivida did not fair much better. The company reported a loss of $2.7 million, or 13 cents per diluted share, on revenue of $360,000 during the three months ended March 31. That compares with a loss of $2.7 million, or 15 cents per diluted share, on revenue of $515,000 during the same period last year.
Upon approval of Iluvien, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits of the drug, the company said.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- iCAD wins Chinese regulatory approval for digital mammography technology
iCAD Inc. (NSDQ:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, announces that it has secured regulatory approval for its SecondLook Digital by the State Food and Drug Administration (SFDA) in the People’s Republic of China. The approval allows iCAD’s SecondLook Digital computer-aided detection (CAD) technology to be sold with GE Digital Mammography Systems in order to assist radiologists in distinguishing potential cancers from other anomalies on a mammogram.
- Avinger wins CE Mark approval for chronic total occlusion treatment
Avinger Inc. announced that it has received CE Mark approval for Wildcat – an innovative, next-generation catheter used in endovascular procedures for the treatment of peripheral artery disease (PAD). In Europe, Wildcat is intended to create a channel in totally occluded peripheral vessels. The device may also be used to facilitate the placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions, or CTO) in the peripheral vasculature prior to further percutaneous intervention.
- Insys announces NDA acceptance for Fentanyl SL spray
Insys Therapeutics Inc. (formerly NeoPharm Inc.) (OTC:NEOL.PK) announced that the FDA accepted its NDA for Fentanyl SL Spray. The FDA will notify Insys of its PDUFA date in the 74-day letter which is expected in the upcoming weeks.
- Medtronic wins Health Canada approval for cryoballoon ablation
Medtronic of Canada Ltd. announced that Health Canada has approved its Arctic Front® Cardiac CryoAblation Catheter System, the first and only Cryoballoon in Canada indicated for the treatment of patients suffering from paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.
- Bioness Inc. wins FDA 510(k) for NESS L300 Plus system
Bioness Inc. announced that it has received 510(k) clearance from the FDA for its NESS L300® Plus System. The device combines the Company’s NESS L300® Foot Drop System with a thigh stimulation cuff, to provide knee flexion and extension in addition to ankle dorsiflexion during gait. The NESS L300 Plus is intended for persons with upper motor neuron injury or disease resulting from stroke, multiple sclerosis, traumatic brain injury and spinal cord injury. The device also may facilitate muscle re-education, prevent/retard muscle atrophy, maintain or increase range of motion and increase local blood flow.
- FDA licenses Sanofi Pasteur’s influenza vaccine with new delivery device
Sanofi Pasteur, the vaccines division of Sanofi (NYSE:SNY), announced the FDA has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone Intradermal (Influenza Virus Vaccine). Fluzone Intradermal vaccine is indicated for active immunization of adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. The new formulation of Fluzone Intradermal vaccine is the first influenza vaccine licensed in the U.S. that uses a novel microinjection system for intradermal delivery.
- Abbott wins CE Mark for Insulinx glucose monitor
Abbott announced that it has received CE Mark (Conformité Européenne) for its new FreeStyle InsuLinx Blood Glucose Monitoring System, the first blood glucose monitoring device from Abbott that includes a mealtime (bolus) insulin calculator for calculating suggested insulin doses. The new FreeStyle InsuLinx System also offers several additional user-friendly features, including a touch screen interface, automated logbook, personalization preferences and USB connectivity for plug-and-play reports via the new FreeStyle Auto-Assist data management software.
- Valor Medical wins CE Mark for cerebral aneurysms treatment
Valor Medical announced that it has received CE Mark approval for Neucrylate AN for treating cerebral aneurysms. Neucrylate AN is a liquid embolic device that is injected through a microinfusion catheter into the aneurysm. When Neucrylate AN comes in contact with the blood in the aneurysm it immediately changes from a liquid into a porous, elastic, sponge like material. Unlike conventional micro-coils used for treating cerebral aneurysms Neucrylate AN fills the entire aneurysm – regardless of its size or shape.
- Brainlab wins 510(k) for HybridArc software for radiosurgery
Brainlab has received 510(k) clearance from the FDA for its HybridArc radiosurgery planning solution. This innovative software package will enable healthcare professionals to increase the efficiency of existing Linac (linear accelerator) radiosurgery hardware and offer fast, high precision volumetric arc radiosurgery treatment without the need for costly hardware upgrades.
- Meridian Bioscience lands 510(k) for Premier C. difficile GDH assay
Meridian Bioscience Inc. (NSDQ:VIVO) announced that it has received clearance from the FDA for a Clostridium difficile immunoassay named Premier(TM) C. difficile GDH. This product expands the Company’s existing portfolio of C. difficile tests and has been available in Europe and the rest of world since October of 2010. The assay detects a common antigen produced by toxigenic and non-toxigenic forms of C. difficile bacteria.