The United States Patent and Trademark Office (US PTO) has granted Patent No. 8,129,431 to ISTA Pharmaceuticals' once-daily topical non-steroidal anti-inflammatory product Prolensa (bromfenac ophthalmic solution) 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., PhD, president and CEO 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.”

Prolensa (bromfenac ophthalmic solution) is being developed as a once-daily topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. PROLENSA incorporates a lower concentration of bromfenac than the company's current once-daily NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09% in a new, optimized formulation. From 2005 until 2011, ISTA marketed XIBROM (bromfenac ophthalmic solution) 0.09% in the US for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In October of 2010, ISTA received FDA approval for once-daily BROMDAY and discontinued shipments of XIBROM in February 2011. ISTA acquired US ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. BROMDAY is currently the only once daily treatment option in the $370 million US ophthalmic non-steroidal anti-inflammatory market. Prolensa is an investigational drug and not yet available for commercial use.

ISTA Pharmaceuticals, Inc. is a fast growing and the third largest branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma and ocular itching associated with allergic conjunctivitis.