ISTA Pharmaceuticals representatives say they intend to file a new drug application (NDA) with the FDA for the company’s bromfenac ophthalmic solution (Prolensa) before the end of June, based on the results of two phase III studies.
Irvine, CA-ISTA Pharmaceuticals representatives say they intend to file a new drug application (NDA) with the FDA for the company’s bromfenac ophthalmic solution (Prolensa) before the end of June, based on the results of two phase III studies.
Results of the second phase III study of the once-daily topical nonsteroidal anti-inflammatory drug (NSAID) product for the treatment of ocular inflammation and pain following cataract surgery were presented in a poster session at the recently concluded Association for Research in Vision and Ophthalmology (ARVO) annual meeting. The findings showed that the solution met the study’s primary and secondary efficacy endpoints; it produced a statistically greater clearing of study participants’ ocular inflammation by day 15, and a greater proportion of study participants receiving the drug were pain-free 1 day after cataract surgery than were those receiving placebo.
The company presented similar results from its first phase III study in a poster session at the American Society of Cataract and Refractive Surgery annual meeting in April. Data from both studies were collected under a common protocol, and the studies were conducted and analyzed as two independent studies in the United States.
Additional data from the ARVO poster presentation, titled “Efficacy of low-concentration, modified bromfenac ophthalmic solution administered once daily for ocular inflammation and pain associated with cataract surgery,” demonstrated no serious drug-related ocular or systemic adverse events and showed that the drug’s safety profile was consistent with the company’s currently marketed once-daily topical NSAID (Bromday), which contains a higher concentration of bromfenac, 0.09%, than the drug being tested.
Authors of the ARVO poster were Sharon K. Klier, MD, MPH; James H. Peace, MD; Damien F. Goldberg, MD; James A. Gow, MD; and Timothy R. McNamara, PharmD for the Low Concentration Bromfenac Ophthalmic Solution Once Daily Study Group.
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