Company announced that the United States Patent and Trademark Office has issued Patent No. 8,129,431 with claims covering PROLENSA(TM) (bromfenac ophthalmic solution), ISTA's once-daily topical nonsteroidal anti-inflammatory product for the treatment of ocular inflammation and pain following cataract surgery. The patent was issued to ISTA's licensor, Senju Pharmaceuticals Co. Ltd., and was granted a patent term adjustment that extends the patent life originally set to expire January 2024 to September 2025.
"The issuance of this patent broadens and further extends the intellectual property position for pipeline products in our bromfenac franchise," said Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "As noted earlier in the year, our bromfenac franchise has multiple barriers to entry, including Hatch-Waxman exclusivity and additional pending patents. This patent should provide protection for not only our new product candidate PROLENSA, but also a potential bromfenac adjunct therapy for age-related macular degeneration (AMD)."
Dr. Anido continued, "The new, optimized formulation used for PROLENSA enhances the penetration of bromfenac into ocular tissues, allowing us to lower the concentration of bromfenac, while maintaining the convenience of once-daily use currently prescribed with BROMDAY. We anticipate filing a New Drug Application (NDA) with the FDA for PROLENSA in the first half of 2012, with a commercial launch following approval planned in early 2013. Because PROLENSA has the advantage of offering a lower concentration of the active ingredient bromfenac with high efficacy and safety, we plan to discontinue BROMDAY sometime after the successful launch of PROLENSA."