Article

Sirion's difluprednate is commercially available

Sirion Therapeutics Inc. announced that a difluprednate ophthalmic emulsion 0.05% (Durezol) indicated for the treatment of inflammation and pain associated with ocular surgery is now commercially available.

Key Points

Tampa, FL-Sirion Therapeutics Inc. announced that a difluprednate ophthalmic emulsion 0.05% (Durezol) indicated for the treatment of inflammation and pain associated with ocular surgery is now commercially available.

"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. "Because [the emulsion] 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 [the corticosteroid] will give patients and physicians a more comprehensive option for postoperative care."

The company also announced the completion of two phase IIIb studies that evaluated the ophthalmic emulsion for the management of postoperative inflammation in which treatment was initiated 1 day prior to surgery. The studies were conducted in 245 patients undergoing unilateral ocular surgery, in multicenter, randomized, double-masked, placebo-controlled, parallel-group trials.

"The phase IIIb 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," said Steven Silverstein, MD, of Silverstein Eye Centers. Dr. Silverstein was a principal investigator in the q.i.d. 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, [the emulsion] administered both b.i.d. and q.i.d. was more effective than placebo in treating postoperative ocular inflammation and relieving ocular pain/discomfort as early as day 3 or 4," he said.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
Shehzad Batliwala, DO, aka Dr. Shehz, discussed humanitarian ophthalmology and performing refractive surgery in low-resource, high-risk areas at the ASCRS Foundation Symposium.
(Image credit: Ophthalmology Times) ASCRS 2025: Advancing vitreous care with Inder Paul Singh, MD
(Image credit: Ophthalmology Times) The Residency Report: Study provides new insights into USH2A target end points
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
Patricia Buehler, MD, MPH, founder and CEO of Osheru, talks about the Ziplyft device for noninvasive blepharoplasty at the 2025 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Bonnie An Henderson, MD, on leveraging artificial intelligence in cataract refractive surgery
© 2025 MJH Life Sciences

All rights reserved.