Eyes on New Product Development

• Alimera Sciences announced that the Spanish Agency of Drugs and Medical Devices has granted marketing authorization to Iluvien^® (fluocinolone acetonide) for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies (January 2013).

• Bausch+Lomb and Nicox announced that Bausch+Lomb has initiated its Phase 3 clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension (January 2013).

• Novartis' division, Alcon, recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Jetrea^® (ocriplasmin) for the treatment of vitreomacular traction, including instances where the macular hole diameter is ≤400 microns (January 2013).

• Santen Ltd. has entered into a research collaboration agreement for posterior ocular diseases with Clearside Biomedical, Inc., for CLS1001 and other products for the treatment of ocular choroidal neovascularization and inflammatory diseases of the posterior segment (January 2013).

• Bio-Light Israeli Life Science Investments announced an investment in D.E.S. Diagnostics Ltd., which is developing an innovative stick that enables diagnosis and monitoring of dry eye syndrome by examining various parameters in the tear fluid (January 2013).

• Gilead Sciences has asked the U.S. FDA to grant five years of exclusivity to its recently approved Stribild^™ (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection. The firm petitioned that exclusivity is warranted, because its fixed dose combination drug contains two so-called active moieties that have never before been approved in any other drug application (January 2013).

• The U.S. FDA said that the government would not appeal a decision that appears to limit the agency's regulation of pharmaceutical companies' off-label drug marketing. The officials said the FDA would not ask the U.S. Supreme Court to hear a case called U.S. v. Caronia (January 2013).

• The U.S. FDA today approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) from Sun Pharma Global FZE. Doxorubicin hydrochloride liposome injection is currently on the FDA's drug shortage list. “The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” said Capt. Valerie Jensen, R.Ph., Director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA. In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced that it would exercise enforcement discretion for temporary controlled importation of Lipodox^® (doxorubicin hydrochloride liposome injection), which was not approved in the United States (February 2013).

• A patient with chronic fatigue syndrome is fasting to protest an FDA decision regarding the availability of an investigational medication, rintatolimod (proposed trade name, Ampligen). The FDA issued a public response letter in which the regulatory actions were reviewed, including a refusal to file on a new drug application, a negative advisory committee, and most recently, a complete response to Hemispherx Biopharma stating that this application cannot be approved in its present form (www.fda.gov/Drugs/NewsEvents/ucm337750.htm, February 2013).