Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced recently that Durezol (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 surgery.

"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 (www.durezol.com), telemarketing, a reimbursement hotline, a patient-assistance program, and a customer support number (1-866-4SIRION).

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.