Results from Phase 3b Studies with Durezol Dosed Prior to Surgery
TAMPA, Fla., Oct. 6 /PRNewswire/ -- Sirion Therapeutics, Inc., a
privately held ophthalmic-focused biopharmaceutical company, announced
today that Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% is now
commercially available. Durezol, which was approved by the U.S. Food and
Drug Administration in June 2008, is a topical ophthalmic corticosteroid
indicated for the treatment of inflammation and pain associated with ocular
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"We are excited to provide eye care professionals with a new and powerful topical steroid," said Susan Benton, Senior Vice President of Sales and Marketing for Sirion Therapeutics, Inc. "Because Durezol is the first and only steroid with an approval for both inflammation and pain, it is the first innovation in the strong steroid class in over 35 years. We believe Durezol will give patients and physicians a more comprehensive option for postoperative care."
Sirion Therapeutics has built a fully-staffed commercial infrastructure comprised of a national specialty sales force that will promote Durezol, a Medical Science Liaison team that will communicate clinical information to the medical community, and a managed markets group that will secure access to Durezol through pharmacies and insurance plans.
Other marketing and product support initiatives in progress include an extensive sampling program, direct mail communications to physicians and pharmacists, the Durezol web site (http://www.durezol.com), telemarketing, a reimbursement hotline, a patient-assistance program, and a customer support number (1-866-4SIRION).
Durezol Phase 3b Studies
Sirion also announced today the completion of two Phase 3b studies that evaluated Durezol for the management of postoperative inflammation in which treatment was initiated one day prior to surgery. The multicenter, randomized, double-masked, placebo-controlled, parallel-group trials were conducted in 245 patients undergoing unilateral ocular surgery. In the first study of 124 patients, Durezol or placebo was dosed 4 times daily (QID), while in the second study, 121 patients received Durezol or placebo twice daily (BID).
"The Phase 3b studies represent an approach to therapy that is most similar to the current standard of care, meaning most physicians treat inflammation prophylactically rather than waiting for it to occur," explained Steven Silverstein, M.D. of Silverstein Eye Centers. Dr. Silverstein was a principal investigator in the QID study and also serves as a clinical assistant professor of ophthalmology at the University of Missouri-Kansas City School of Medicine and the University of Health Sciences. "Overall, the results from these studies show that by any definition utilized, Durezol administered both BID and QID was more effective than placebo in treating postoperative ocular inflammation and relieving ocular pain/discomfort as early as Day 3/4."
A significantly greater percentage of patients receiving Durezol QID or BID achieved a clinical response (defined as less than or equal to 5 anterior chamber cells and no flare) by Day 14: 81.3% of the Durezol treated patients in the QID group had a clinical response versus 25.0% of the placebo QID group (P < 0.0001); 74.7% of the Durezol BID patients had a clinical response versus 42.5% of patients in the placebo BID group (P < 0.001). Both Durezol groups maintained superiority over the placebo groups through Day 28, demonstrating that efficacy was definitive and did not decrease or reverse over time.
Ocular pain/discomfort was measured using the Visual Analogue Scale (VAS) score of 0-100 with 0 equal to no pain and 100 equal to maximal pain. The percentage of patients who were free of ocular pain/discomfort, reflected by a VAS score of 0, was superior and statistically significant for the Durezol groups versus the placebo groups in both the QID and BID studies as early as Day 3/4 and throughout the study period.
Six percent of the Durezol QID patients and 3.7% of the Durezol BID patients experienced a criterion increase in intraocular pressure, defined as a pressure of greater than or equal to 21 mmHg and a change from baseline greater than or equal to 10 mmHg at the same visit, compared with 0% in both of the placebo groups.
"Durezol has shown efficacy across multiple endpoints, including pain reduction. I believe it provides a potent new treatment option with a favorable safety profile," commented Dr. Silverstein. "It is a welcome improvement to the armamentarium of ocular pharmaceuticals, particularly since ocular inflammation is common to the majority of conditions that ophthalmologists treat."
About Postoperative Inflammation
More than five million ophthalmic surgeries are performed each year in the United States. Postoperative inflammation and pain are common occurrences following these procedures and if left untreated, can interfere with a patient's visual rehabilitation or lead to further complications. Corticosteroids and non-steroidal anti-inflammatory drugs are commonly used by healthcare professionals following ophthalmic surgery.
Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic corticosteroid for the treatment of inflammation and pain associated with ocular surgery. Difluprednate, the active ingredient in Durezol, is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. Prior to U.S. approval, the efficacy and safety of difluprednate in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan. In two U.S. Phase 3 trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol effectively reduced inflammation and pain. Mean intraocular pressure for all study groups remained within the normal range throughout the study. Durezol is being studied in other ocular inflammatory diseases, including a U.S. Phase 3 study evaluating Durezol for the treatment of anterior uveitis.
Dosage and Administration
The recommended dosage and administration of Durezol is to instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and then continue throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week with tapering based on the response.
Important Safety Information
Durezol, like other corticosteroids, is contraindicated in patients with viral diseases of the cornea and conjunctiva, and also in fungal infections or mycobacterial infections of the eye or ocular structures. Prolonged use of corticosteroids may increase the hazard of secondary ocular infections, exacerbate the severity of ocular viral infections, and increase the development of fungal infections of the cornea. It is important to monitor intraocular pressure when using ophthalmic steroids. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with Durezol included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1-5% of patients included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse events occurring in < 1% of patients included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been the consequence of the surgical procedure.
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, and geographic atrophy associated with dry AMD. For more information, please visit http://www.siriontherapeutics.com.
|SOURCE Sirion Therapeutics, Inc.|
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