www.medscape.com
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`FDA Approves Prolensa for Cataract Surgery Postop Pain
`|April 08, 2013
`Lara C. Pullen, PhD
`Today the Food and Drug Administration (FDA) approved a new formulation of a once-daily nonsteroidal anti-inflammatory drug
`(NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract surgery. The newly
`approved 0.07% bromfenac ophthalmic solution (Prolensa, Bausch + Lomb) will likely replace the currently available 0.09%
`bromfenac ophthalmic solution.
`
`Bromfenac is a critical ingredient in the formulation, as it facilitates ocular penetration of the NSAID. The newly approved drops are
`administered 1 drop daily beginning 1 day before surgery and continuing through the first 14 days postsurgery.
`
`FDA approval was based on 2 randomized, double-masked studies in patients undergoing cataract surgery. The studies
`demonstrated the bromfenac ophthalmic solution 0.07% to be superior to vehicle for the reduction of inflammation and pain.
`
`"The data show that once-daily dosing with Prolensa provides powerful and rapid control of inflammation and pain following cataract
`surgery, confirming the potency of this NSAID and the benefits of the new formulation," said Steven M. Silverstein, MD, founder of
`Silverstein Eye Centers in Kansas City, Missouri, in a Bausch + Lomb press release. "Prolensa reduces the amount of medication
`placed on the healing eye while maintaining a high degree of efficacy and ocular comfort."
`
`The package insert will include warnings for sulfite allergic reactions, slow or delayed healing, and potential for cross-sensitivity.
`Adverse reactions (reported in from 3% to 8% of patients) include anterior chamber inflammation, foreign body sensation, eye pain,
`photophobia, and blurred vision.
`
`Bausch + Lomb also offers a 0.09% bromfenac ophthalmic solution that was approved in 2010 for once-daily use. The newly
`approved formulation represents a new, modified ophthalmic formulation. The safety profile of the new formulation is consistent with
`the safety profile of the 0.09% formulation. It is expected, however, that patients will benefit from receiving the same amount of
`efficacy with a lower dose of medication.
`
`Cite this article: FDA Approves Prolensa for Cataract Surgery Postop Pain. Medscape. Apr 08, 2013.
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