The Food and Drug Administration has approved Sirion Therapeutics' new drug application for Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review and makes Durezol the first ophthalmic steroid indicated for inflammation and pain.

"Durezol, our first product to be approved by the FDA, is a potent topical steroid that works rapidly and effectively to resolve postoperative inflammation and pain," said Barry Butler, president and CEO of Sirion.

"We look forward to launching the first innovation in the strong steroid class in more than 35 years, and the first steroid to have an indication for the treatment of postoperative pain. We believe that having access to a steroid that treats both inflammation and pain gives physicians a more complete treatment approach."

In two Phase III trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol rapidly reduced inflammation and pain. Mean intraocular pressure for all study groups remained within the normal range throughout the study. 

"Rapid resolution of inflammation and pain is very important following ocular surgery," said Michael Korenfeld, MD, assistant clinical professor of Ophthalmology and Visual Sciences at Washington University, St. Louis, and principal investigator for the Phase III trials. "It is important to point out that in these Phase III studies, patients were dosed for the first time after the ocular trauma from surgery had occurred.  The results from these studies, particularly the ability to eliminate postoperative pain demonstrate that Durezol is a powerful option for postoperative care."

The two U.S. Phase III multicenter studies evaluated the safety and efficacy of Durezol compared to placebo dosed b.i.d and q.i.d. beginning 24 hours after intraocular surgery. Treatment occurred over four weeks and included tapering. The studies included 438 subjects who presented with significant inflammation as evidenced by an anterior chamber cell grade 2 or higher (greater than 10 cells) the day after surgery.

Both regimens had similar overall efficacy in the reduction of anterior chamber cells two weeks following surgery (86 percent in b.i.d and 87 percent in q.i.d. The q.i.d. regimen had a small numerical advantage in the number of patients who were completely free of inflammation and pain at the one week time point. Because of this numerical advantage, and the desire to treat inflammation aggressively, the q.i.d. dosing regimen was chosen for recommendation to doctors.

Durezol was well-tolerated with few treatment-related adverse events. One of the most common side effects seen with steroids in ophthalmic use is a rise in IOP. Three percent of subjects in each of the b.i.d. and q.i.d. groups, and 1 percent of subjects in the placebo group met the criterion for a clinically significant rise in IOP, defined as an observed value of greater than or equal to 21 mmHg and a change from baseline of 10 mmHg. 

Durezol 0.05% is a topical ophthalmic corticosteroid for the treatment of postoperative inflammation and pain associated with ocular surgery. Durezol is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. Prior to U.S. approval, the efficacy and safety of Durezol in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan. Sirion Therapeutics plans to make Durezol commercially available in late 2008.

Two Phase IIIb studies evaluating Durezol for the management of inflammation and pain after intraocular surgery have been completed in which Durezol treatment was initiated one day prior to surgery. Durezol is also being studied in other ocular inflammatory diseases, including a U.S. Phase III study evaluating Durezol for the treatment of anterior uveitis.

Allergan Will Seek Bimatoprost NDA For Eyelash Growth

Allergan intends to file a New Drug Application by end of the third quarter of 2008 with the FDA for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth.

"Our exploration of bimatoprost as an eyelash growth enhancer reflects our continuing commitment to offer innovative medical aesthetic treatments that are science-based, with the clinically proven safety and efficacy that consumers have come to trust Allergan to provide," said Scott Whitcup, MD, Allergan's executive vice president, Research and Development. "We are pleased with the results of our clinical program and believe this innovative product, if approved, could meet a significant and currently unmet demand in the medical aesthetic marketplace." The global mascara market is presently estimated to be $3.7 billion annually. If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year. Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth. If approved by the FDA, Allergan's bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States.

FDA Approves Allergan's Intravitreal Triamcinolone

The FDA also approved Allergan's Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Trivaris is delivered via intravitreal injection, and its ophthalmic indications include sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. These are inflammatory conditions that can result in vision loss. "Retinal diseases are currently the leading cause of blindness in developed countries and represent a significant unmet need in eye care," said Scott Whitcup, MD, Allergan's executive vice president, Research and Development. "Trivaris marks the first approval for Allergan resulting from our strategic focus on the development of therapies for back-of-the-eye diseases, and we remain committed to bringing forth innovative new treatments for patients suffering from retinal diseases."

 

Benchmarking Data Offered

The American Academy of Ophthalmology and the American Academy of Ophthalmic Executives have completed their 2007 Benchmarking Survey. The survey will provide AAO members with a standard to measure practice efficiency by comparing their practices to the results from similar practices.

The database uses information submitted by Academy and AAOE members on 36 separate issues, ranging from operating expense ratio to patient flow ratios, for the calendar year 2006. The survey was designed to ensure the privacy and security of the data submitted. The survey collected sufficient data to enable comparisons across a number of practice types and geographies. Members who participated in the survey will be able to run reports to see how their benchmarks fare against those of peers. All AAO members will have access to a summary of the database results.

The database also provides valuable information for educating legislators and government officials. The release of the 2006 data in the 2007 Benchmarking Survey marks the first year of an ongoing Academy/AAOE project to collect current ophthalmology practice data and produce useful benchmarks for Academy members. The database is currently open for submissions of 2007 data. For more information, members can visit aao.org/benchmarking.