Navigation Links
Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes

TAMPA, Fla., Jan. 26 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.

(Logo: )

"Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States," explained Barry Butler, CEO of Sirion Therapeutics. "If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the U.S. in almost three decades. This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis."

To assess the efficacy and safety of ganciclovir, four randomized, multicenter trials compared ganciclovir gel, 0.15%, with acyclovir ointment, 3%, both of which are used as first-line therapies outside the U.S. to treat herpetic keratitis. The studies found that ganciclovir is as effective as acyclovir and that the tolerability of ganciclovir was superior to acyclovir, particularly with regard to blurring and stinging or burning sensations after instillation. Additionally, since ganciclovir is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface.

"Based upon its proven safety and efficacy, the introduction of a new topical antiviral agent with improved tolerability, such as ganciclovir ophthalmic gel, would clearly be a valuable treatment option for U.S. clinicians who treat herpetic keratitis," noted Herb Kaufman, M.D., Sirion Ophthalmologist Emeritus and renowned herpetic keratitis researcher and clinician.

About Herpetic Keratitis

Herpes simplex virus (HSV) infections are very common, with nearly 60% of the U.S. population showing evidence of infection by age five. Approximately 1% of infected patients develop ocular outbreaks, with 20,000 primary cases of ocular herpes diagnosed in the U.S. each year.

After the primary infection, ocular HSV typically becomes latent until triggers such as stress, UV radiation, and hormonal changes reactivate the virus and cause recurrent outbreaks. Those recurrences account for an additional 28,000 cases per year in the U.S. The risk of blindness increases with the number and severity of recurrences, making prompt treatment imperative to limit scarring and other more serious complications caused by herpetic epithelial ulcers.

About Ganciclovir Ophthalmic Gel, 0.15%

Sirion Therapeutics has an exclusive licensing agreement with Laboratoires Thea of France for the U.S. rights to develop and market ganciclovir ophthalmic gel, 0.15%. Available in Europe under the brand name Virgan(R), this topical ophthalmic antiviral gel has successfully treated herpetic viral infections for more than 10 years.

In 2007, Sirion received orphan drug designation from the FDA for ganciclovir ophthalmic gel. This designation is a special status for diseases or conditions that affect fewer than 200,000 patients in the United States.

About Sirion Therapeutics, Inc.

Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's diverse product portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, glaucoma and geographic atrophy associated with dry AMD. For more information, please visit

About Laboratoires Thea

Laboratoires Thea ( was founded in 1994 and is managed by Henri and Jean-Frederic Chibret. Laboratoires Thea is the leading independent ophthalmic group in Europe and is committed to the development and marketing of innovative ophthalmic drugs, medical devices and nutraceuticals.

SOURCE Sirion Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain
2. Sirion Therapeutics Preclinical Studies: Two New Potential Advances in Treatment of Retinal Diseases to be Presented at ARVO
3. Sirion Therapeutics Highlights Pivotal Trial Results of Durezol(TM) at the American Society of Cataract and Refractive Surgery Annual Symposium
4. Sirion Therapeutics Acquires Worldwide License to Develop New Treatment for Ocular Diseases
5. Sirion Therapeutics Supports Ophthalmic Education
6. Frost & Sullivan Recognizes ESBATechs Innovation in Developing Antibody Fragments for Biologic Therapeutics
7. Cell Therapeutics, Inc. (CTI) to Present at 11th Annual BIO CEO & Investor Conference
8. Cell Therapeutics, Inc. Provides Update on the Special Meeting of Shareholders
9. Nile Therapeutics Announces Focus on CD-NP for Acute Heart Failure and Termination of 2NTX-99 Program
10. Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009
11. Synvista Therapeutics Announces Progress in Phase 2 Clinical Trial Program for Alagebrium
Post Your Comments:
(Date:11/27/2015)... November 27, 2015 ... popularity of companion diagnostics is one of ... market with pharmaceutical companies and diagnostic manufacturers ... tests. . --> ... report on global cancer biomarkers market spread ...
(Date:11/25/2015)... India , November 26, 2015 ... The Global Biobanking Market 2016 - 2020 report ... by maintaining integrity and quality in long-term samples, ... enabling long-term cost-effectiveness. Automation minimizes manual errors such ... the technical efficiency. Further, it plays a vital ...
(Date:11/25/2015)... November 25, 2015 Studies reveal ... human plaque and pave the way for more effective treatment ... cats     --> ... diagnosed health problems in cats, yet relatively little was understood ... collaborative studies have been conducted by researchers from the WALTHAM ...
(Date:11/25/2015)... QUEBEC CITY , Nov. 25, 2015 /PRNewswire/ ... "Company"), affirms that its business and prospects remain ... , Zoptrex™ (zoptarelin doxorubicin) recently received DSMB ... program to completion following review of the final ... met Phase 2 Primary Endpoint in men with ...
Breaking Biology Technology:
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... Fingerprint Sensors - Technology and Patent Infringement Risk Analysis" ... --> --> Fingerprint sensors using capacitive ... The fingerprint sensor vendor Idex forecasts an increase of ... mobile devices and of the fingerprint sensor market between ...
(Date:11/20/2015)... November 20, 2015 NXTD ) ... on the growing mobile commerce market and creator of ... Pereira , was recently interviewed on The RedChip ... on this weekend on Bloomberg Europe , Bloomberg ... --> NXTD ) ("NXT-ID" or the "Company"), ...
(Date:11/19/2015)... , Nov. 19, 2015  Based on its ... & Sullivan recognizes BIO-key with the 2015 Global Frost ... year, Frost & Sullivan presents this award to the ... catering to the needs of the market it serves. ... line meets and expands on customer base demands, the ...
Breaking Biology News(10 mins):