Eyes on New Product Development

• Bausch+Lomb submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for PROLENSA™ (bromfenac ophthalmic solution), for the treatment of ocular inflammation and pain after cataract surgery with a once-daily dosing regimen (June 2012).

• Genentech's Biological License Application (BLA) for Lucentis^® (ranibizumab) for the treatment of diabetic macular edema was recommended for approval by an U.S. FDA Advisory Committee (July 2012).

• InSite Vision initiated a Phase 3 clinical study of BromSite™ (ISV-303, bromfenac) for the reduction of pain and inflammation after cataract surgery (August 2012).

• Nicox announced that based upon results of a phase 2b study with BOL-303259-X, a novel nitric oxide-donating prostaglandin F2-alpha analog, they will initiate a global Phase 3 program. Nicox also announced an investment in Altacor (March 2012) and has entered into a licensing arrangement with Rapid Pathogen Screening to gain access to in-office diagnostic products (June 2012).

• NovaBay started enrollment in a Phase 2b study of topical NVC-422 for the treatment of adenoviral conjunctivitis (May 2012).

• Ophthotec completed a Phase 2b study of concomitant use of E10030, an anti-PDGF aptamer, with ranibizumab in the treatment of wet age-related macular degeneration (June 2012).

• pSivida Corp. announced the enrollment of the first patient in an investigator-sponsored clinical trial of its injectable sustained release device of fluocinolone acetonide in posterior uveitis (July 2012).

• Thrombogenics' BLA for Jetrea™ (ocriplasmin) for the treatment of symptomatic vitreomacular adhesions, including macular hole, was recommended for approval by a U.S. FDA Advisory Committee (July 2012).

• AARDEX Group SA, manufacturer of the MEMS^® electronic compliance monitor, has been acquired by MeadWestvaco Corporation (June 2012).

• Ocular Therapeutix, Inc. completed a study of a sustained release travoprost-loaded punctum plug in patients with elevated intraocular pressure (July 2012).

• The FDA announced a recall of all sterile products sold by Franck's Pharmacy since November 2011 due to the possibility of lack of sterility. Previously, products from this compounding pharmacy have been associated with fungal infections with Brilliant Blue G (May 2012).

• In continued U.S. discussions over a law to allow for biosimilars (generic biological products), there is a debate over whether the generic product would be allowed to use the same generic (USAN) name as the innovator (July 2012). ¹

• The Food and Drug Administration Safety and Innovation Act (FDASIA, S 3187), renewal of the Prescription Drug User Fee Act, has been signed into law. This act includes user fees for future potential biogenerics and an update on requirements for pediatric studies. www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm (July 2012)

• The U.S. Congress the Generic Drug User Fee Act (GDUFA) in an effort to get generic drugs to market in a timely manner. The Act authorizes the collection of user fees from generic drug-manufacturing companies for the first time in the industry's history (July 2012).