Archive for the 'FDA Approval' Category

Alcon To Purchase Ophthalmic Pharmaceutical Assets From Sirion

AlconAlcon has announced that it will purchase the rights in the United States for two FDA-approved topical eye care products from Sirion Therapeutics, Inc. The two products purchased are Durezol™, a marketed ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, and Zirgan™, a recently approved antiviral for the treatment of acute herpetic keratitis (corneal ulcers).

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VisionCare to give presentations on its implantable telescope technology

visioncareVisionCare Ophthalmic Technologies Inc, a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), announced scientific and corporate presentations on its implantable telescope technology. VisionCare’s investigational telescope implant is the first medical device to be recommended for FDA approval by the FDA Ophthalmic Devices Advisory Panel for End-Stage AMD, a leading cause of untreatable blindness in the US.

ISTA Pharma won the FDA support for Bepreve eye drops

ISTAThe pharmaceutical company ISTA Pharmaceuticals won unanimous support from the FDA committee for the approval of Bepreve eye drops for the treatment of itchy eyes. The eye drops are designed to treat patients aged 2 years and more with itchy eyes due to allergies. The vote by the FDA was 7-0 as it believed that ISTA had proved the effectiveness and safety of Berpreve and the eye medication will be sold by prescription only.

ISTA planning on FDA approval for bromfenac label change

ISTAISTA Pharmaceuticals is planning to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution. It has obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery. The topical non-steroidal anti-inflammatory compound currently is labeled for twice-daily use beginning 24 hours after such surgeries.

CE approves IOPtima noninvasive treatment of glaucoma

IOptimaIOPtima has received CE approval for its laser based system for noninvasive treatment of glaucoma. IOPtima’s CO2 laser system, IOPtiMate OT-134, alleviates intra-ocular pressure through a fast, simplified, efficient and cost-effective filtration procedure. This intra-ocular pressure is the primary cause of damage to the optic nerve in glaucoma patients. The approach, says IOPtima, is expected to compete as the preferred first line of glaucoma treatment.

Allergan receives approval for Ozurdex

Multi-specialty healthcare company Allergan Inc announced that it has received approval from the FDA for Ozurdex 0.7 mg indicated for the treatment of the eye disease macular edema. Ozurdex is a first-of-its kind therapy dispensed by way of intravitreal injection delivering dexamethasone, a highly potent corticosteroid, through its proprietary and innovative Novadur solid polymer delivery system.

FDA approves Besivance for bacterial conjunctivitis

The FDA has approved a new antibacterial eyedrop called Besivance for the treatment of a contagious eye infection called bacterial conjunctivitis, commonly known as “pinkeye.” Symptoms of bacterial conjunctivitis include red eyes, swelling, eyelids sticking together, itching, watering, and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis generally runs its course in seven to 14 days. Although this infection is common among kids, it can also affect people of other ages.

Akorn Announces FDA Approval Of Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%

Akorn, Inc. has announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%. Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data. Akorn expects to launch Ciprofloxacin in 2009. Of the 20 product approvals received in 2008, 8 were launched in 2008 and 10 are scheduled for launch in the first half of 2009.

Bausch & Lomb’s pink eye drug likely to get FDA recommendation

Bausch & Lomb has announced that its pink eye drug besifloxacin is currently is likely to get recommended by the FDA. Its Dermatologic and Ophthalmic Drugs Advisory Committee voted to recommend approval for besifloxacin 0.6. The drug is required for treatment of bacterial conjunctivitis. Bausch & Lomb plans to start marketing besifloxacin in the U.S. in 2009, pending FDA approval. It can be added that Conjunctivitis is an inflammation of the conjunctiva most commonly due to an allergic reaction or an infection.

FDA approves Bausch & Lomb to market Akreos™ lens

The U.S. Food and Drug Administration (FDA) has approved Bausch & Lomb to commercially launch the Akreos™ Advanced Optics Aspheric Lens  (model AO60) (model AO60) in the market of United States. A foldable acrylic IOL, the lens is implanted with Bausch & Lomb’s single-use AI-28 inserter. This enables single-handed insertion through an un-enlarged standard phaco incision. The lens delivers quality vision, and enhanced contrast sensitivity. Its unique properties make Akreos lens a pathway to micro-incision cataract surgery. This will enable novel lens technologies that can be inserted through smaller incisions.

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