9 January 2012 - US-based ISTA Pharmaceuticals Inc (NASDAQ:ISTA) said on Friday its Japanese partner Senju Pharmaceuticals had obtained a Notice of Allowance from the US Patent and Trademark Office (USPTO) for the company's optimised formulation of bromfenac containing 2-Amino-3-(4-Bromobenzoyl) phenylacetic acid.

The company is expected to be issued a patent in the first six months of 2012 providing protection for its product candidate PROLENSA (bromfenac ophthalmic solution) which is being developed as a once-daily topical nonsteroidal anti-inflammatory compound to treat ocular inflammation and pain after cataract surgery. The patent is also seen to offer protection for a potential bromfenac adjunct treatment for age-related macular degeneration, the company said. The patent is expected to expire in 2024.

In October 2011, the company released statistically significant Phase III results for PROLENSA and now anticipates to submit a New Drug Application (NDA) with the US regulator for PROLENSA by June 2012. ISTA also intends to discontinue its current once-daily product, BROMDAY (bromfenac ophthalmic solution) 0.09%, after the commercial launch of PROLENSA scheduled for early 2013. The company is taking this step because PROLENSA has a lower-concentration of the active ingredient with high safety and efficacy.

ISTA acquired US ophthalmic rights to bromfenac in May 2002 under a licence from Senju Pharmaceuticals, an Osaka-based company which makes eye, nose, ear, throat and skin care products.