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news.Ista Pharmaceuticals has reported positive Phase 3 trial results of its Prolensa (bromfenac ophthalmic solution).
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Prolensa is a once-daily topical nonsteroidal anti-inflammatory (NSAID) compound which is used to treat ocular inflammation and pain following cataract surgery..
The two Phase 3 controlled, double-masked, multi-center, parallel-group and randomized studies have enrolled 440 patients who underwent cataract surgery in one eye (unilateral) and were assigned to receive either Prolensa once daily or placebo (vehicle).
In both Phase 3 studies, Prolensa was better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery.
It also met secondary efficacy endpoint of elimination of ocular pain one day post-surgery.
Ista Pharmaceuticals Clinical Research and Medical Affairs vice president Timothy McNamara said the new formulation used for Prolensa enhances the penetration of the drug into ocular tissues, allowing them to lower the concentration of the active ingredient, bromfenac, while maintaining the convenience of once-daily use currently prescribed with Bromday.
"Based upon the results announced today, we plan to file a new drug application (NDA) with the US Food and Drug Administration (FDA) for Prolensa in the first quarter of 2012, with a commercial launch planned for late 2012 or early 2013." McNamara said.