Ophthalmology Product Guide » Inflammation

Alcon Buys Rights For Durezol and Zirgan

Jim Marino — Thu, 28 Jan 2010 05:07:18 +0000

Alcon 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.

Bepreve approved by the FDA

Jim Marino — Thu, 24 Sep 2009 04:26:09 +0000

The 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

Jim Marino — Thu, 17 Sep 2009 03:55:36 +0000

The 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

Jim Marino — Thu, 10 Sep 2009 04:42:16 +0000

ISTA 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

Jim Marino — Thu, 30 Jul 2009 04:41:56 +0000

Allergan 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.

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

Jim Marino — Tue, 09 Dec 2008 07:08:51 +0000

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.

Data from comparative trial involving Durezol and Pred Forte

Jim Marino — Fri, 17 Oct 2008 10:08:07 +0000

Sirion Therapeutics, Inc. has released results of a comparative trial evaluating the efficacy of Durezol(TM) 0.05% dosed four times daily against Allergan’s Pred Forte(R) 1%, dosed eight times daily. A topical ophthalmic corticosteroid, Durezol was indicated by the FDA in June 2008 for treating pain and inflammation related to ocular surgery. At the end of two weeks, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, showing the potential of Durezol as a steroid.

Akorn gets FDA nod for generic Ophthalmic Solution

Jim Marino — Mon, 28 Apr 2008 19:02:46 +0000

Akorn announced that it has received FDA approval for its Ofloxacin Ophthalmic Solution USP, 0.3%. Ofloxacin Ophthalmic Solution USP, 0.3%, is the generic version of Ophthalmic Solution to treat infections caused by bacteria in conjunctivitis and corneal ulcers. The branded drug had generated sales of approximately $7.5 million in 2007. Akorn plans to manufacture the generic drug in its Decatur, Illinois, facility, and expects to launch the drug in the third quarter of 2008.

FDA grants Durezol priority review status

Jim Marino — Fri, 07 Mar 2008 16:15:50 +0000

Sirion Therapeutics Inc. has received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.