Alcon Buys Rights For Durezol and Zirgan

DurezolAlcon has bought rights for and Zirgan from Sirion Therapeutics Inc. for an undisclosed amount. While Durezol is an ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, Zirgan is an antiviral for the treatment of corneal ulcers. Both products have been approved by the Food and Drug Administration.

Alcon said it has acquired the global rights, excluding Latin America, for Zyclorin, which is being developed as a potential treatment for dry eyes and other diseases.

Alcon Buys Rights For Durezol and Zirgan

Alcon has bought rights for Durezol and Zirgan from Sirion Therapeutics Inc. for an undisclosed amount. While Durezol is an ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, Zirgan is an antiviral for the treatment of corneal ulcers. Both products have been approved by the Food and Drug Administration.

Alcon said it has acquired the global rights, excluding Latin America, for Zyclorin, which is being developed as a potential treatment for dry eyes and other diseases.

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.

Adverse events reported with the use of gentamicin ophthalmic ointment: FDA

AkornThe FDA and CDC officials announced that they have received reports of adverse events associated with the use of gentamicin ophthalmic ointment (0.3%) for prophylaxis against ophthalmia neonatorum or neonatal conjunctivitis. The product is marketed by Lake Forest, Ill.-based Akorn Inc as Gentak. The cases, which occurred in multiple locales and included product from several lots, have involved eyelid swelling and dermatitis that appears a few days after ointment application. Most cases have been mild and have not required additional treatment, but more severe cases have been associated with blistering of the skin.

Production of AzaSite increased by InSite Vision Inc and Inspire

AzasitePharmaceuticals are increasing for production of AzaSite (azithromycin ophthalmic solution) 1 percent in the US and Canada in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%). Erythromycin ophthalmic ointment is approved for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. The ointment was placed on the FDA’s Drug Shortage list.

Bepreve approved by the FDA

ISTAThe FDA has approved Ista Pharmaceuticals’ bepotastine besilate ophthalmic solution 1.5% as a twice-daily eye drop for treating ocular itching due to allergic conjunctivitis. Bepreve (bepotastine besilate ophthalmic solution 1.5%) is a non-sedating, highly selective histamine receptor antagonist that stabilizes mast cells and suppresses the migration of eosinophils through inflamed tissue.

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.

Acuvail receives FDA approval

AllerganAllergan Inc has received the FDA approval for its post-cataract surgery eye solution Acuvail (ketorolac tromethamine ophthalmic solution). The eye solution is aimed at treating pain and inflammation following cataract surgery. Allergan said that more than 3 million cataract surgeries are performed in the US every year. Acuvail is expected to reach the market in September.

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.

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