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Bausch + Lomb recently purchased the assets and U.S. rights for ganciclovir ophthalmic gel 0.15% from Sirion Therapeutics.
Rochester, NY-Bausch + Lomb recently purchased the assets and U.S. rights for ganciclovir ophthalmic gel 0.15% (Zirgan) from Sirion Therapeutics. The acquisition was announced June 3.
"We're pleased to offer our customers and their patients the first new topical ocular antiviral therapy approved in the United States in [more than] 30 years," said Brent Saunders, chief executive officer of Bausch + Lomb. "[Ganciclovir] is an innovative treatment for acute herpetic keratitis that effectively and precisely targets only virally infected cells, resulting in a favorable safety and tolerability profile established in 15 years of use in Europe. An added benefit for patients is the reduced frequency of administration compared [with] older non-specific antiviral drugs."
Sirion previously had obtained the license for the drug's product technology and trademark for the U.S. market from Laboratoires Théa in 2007. The ophthalmic gel became commercially available in the United States in April for the treatment of ocular herpes.
The agency previously granted orphan drug status to the product for acute herpetic keratitis in April 2007. This action conveys special status for rare diseases or conditions affecting fewer than 200,000 patients. The ophthalmic gel has been used to treat corneal ulcers, under the brand name Virgan, in Europe for more than 10 years.
Herpetic keratitis, caused by the herpes simplex virus (HSV), is a significant cause of corneal blindness and a leading indication for corneal transplants. About 50,000 new and recurrent cases are treated in the United States each year. After the initial outbreak, HSV becomes a latent infection in the trigeminal ganglion and possibly the cornea, with repeated recurrences that frequently lead to corneal scarring and ocular inflammation, increasing the risk of blindness.
Bausch + Lomb was not the first company to show an interest in the ophthalmic gel. On Jan. 18, Alcon Laboratories issued a press release announcing the company's intention to acquire the rights from Sirion to ganciclovir and difluprednate ophthalmic emulsion 0.05% (Durezol), a marketed ophthalmic corticosteroid approved to treat inflammation and pain associated with eye surgery.
The finalization of this agreement was expected to occur at the end of the first quarter, according to the statement, but finalization of the deal was contingent upon the customary closing conditions and required regulatory approvals.
Sirion spokesman Drey Coleman explained that upon the governmental review of the sale of ganciclovir to Alcon Laboratories, it was determined that because Alcon Laboratories had a generic drug that was similar, the option of purchasing the ophthalmic gel was removed from the initial agreement between the two companies pending further review. The drug then was put out by Sirion for competitive bids.
Alcon Laboratories said in an e-mail message to Ophthalmology Times that it had no comment beyond the Jan. 18 press release.
Sirion, a privately held biopharmaceutical company located in Tampa, FL, has divested itself of all its products, and the company is expected to close within the next few months, according to Coleman.