ISTA Pharmaceuticals says it snagged the late-stage data it needs to win an approval for Prolensa, which relies on a low concentration of bromfenac to treat pain and inflammation caused by cataract surgery. And now it plans to file an NDA for the treatment in the first quarter of 2012. But another one of its drugs flunked a late-stage test for dry eye disease and now may be headed to the OTC market.
Investigators for the Irvine, CA-based biotech ($ISTA) say that Prolensa passed both its Phase III tests. Provided they can win an FDA approval, ISTA says it will start converting physicians who currently use Bromday over to the new treatment. The news did little to excite investors, though, with ISTA's shares dropping 4% this morning.
"The new, optimized formulation used for Prolensa enhances the penetration of the drug into ocular tissues, allowing us to lower the concentration of the active ingredient, bromfenac, while maintaining the convenience of once-daily use currently prescribed with Bromday," said Timothy R. McNamara, vice president of clinical research and medical affairs of ISTA. "This study had the lowest number of adverse events (greater than 2%) than any of our bromfenac clinical trials for cataract surgery to date."
The news for Remura, a Phase III treatment using a bromfenac ophthalmic solution for dry eye, was not as upbeat. The developer reported that the treatment did not clear the Phase III hurdle on statistical significance.
"The EAST study did not show a significant difference from placebo in this subpopulation, which we believe is partly due to the fact that the EAST study enrolled far fewer patients with mild to moderate dry eye disease," stated McNamara. "We will complete a full analysis of the data, but focus our efforts on the potential use of the vehicle as an over-the-counter artificial tear product."
- read the release on Prolensa
- check out the release on Remura