In October, ISTA reported statistically significant Phase 3 results for its product candidate, PROLENSA™ (bromfenac ophthalmic solution), which incorporates this proprietary formulation of bromfenac.
The Notice of Allowance concludes the substantive examination of this patent application and is expected to result in the issuance of a U.S. patent following completion of administrative processes. The patent is anticipated to issue in the first half of 2012 and expire in 2024.
"This notice of allowance is important to further broaden the intellectual property position for one of our key franchises," said Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "The bromfenac franchise has multiple barriers to entry -- existing Hatch-Waxman exclusivity for BROMDAY™ and Hatch-Waxman exclusivity upon potential approval of PROLENSA, this new allowed patent and additional patents pending. It is a critical step to our continued leadership in the $367 million ophthalmic nonsteroidal anti-inflammatory drug (NSAID) market in the U.S. Once issued, we believe that this patent will provide protection for not only PROLENSA, but also a potential bromfenac adjunct therapy for age-related macular degeneration (AMD)."
Dr. Anido continued, "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 a lower-concentration of the active ingredient with high efficacy and safety, we plan to discontinue our current once-daily product, BROMDAY, sometime after the successful launch of PROLENSA. This is the same commercial strategy we successfully implemented in early 2011 for conversion of our twice-daily XIBROM™ prescriptions to once-daily BROMDAY."