FDA Approves Prolensa
`
`Bausch + Lomb Receives FDA Approval for Prolensa
`
`MADISON, NJ - Bausch + Lomb, the global eye health
`company, today announced that the U.S. Food and Drug
`Administration (FDA) has approved the company's New Drug Application (NDA) for Prolensa (bromfenac ophthalmic solution)
`0.07 percent prescription eye drop, an innovative once-daily nonsteroidal anti-inflammatory drug (NSAID) for the treatment
`of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa will be
`available in 1.6ml and 3ml bottle sizes.
`
`Prolensa provides powerful and rapid resolution of inflammation and pain by leveraging the unique potency of the bromfenac
`molecule in a formulation designed to facilitate ocular penetration. The advanced formulation allows for a lower
`concentration
`of bromfenac in a once daily dosing regimen. Prolensa is a solution
`that does not require shaking to deliver
`a consistent dose in each drop.
`
`"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,
`M.D., FACS, founder of Silverstein Eye Centers in Kansas City, MO. "Prolensa reduces the amount of medication placed on
`."
`the healing eye while maintaining a high degree of efficacy and ocular comfort
`
`of patients
`The efficacy of Prolensa was evaluated in two randomized, double-masked, vehicle-controlled studies
`undergoing cataract surgery. Each randomized patient received Prolensa or vehicle starting with one drop into the surgical eye
`on the day prior to and the day of surgery, and for 14 days following surgery. The primary efficacy endpoint was complete
`clearing of ocular inflammation (assessed by the summed ocular inflammation score, SOIS, which includes cells and flare) by
`day 15. The secondary efficacy endpoint was the number of subjects that were pain free on day one after surgery.
`
`Results from the pivotal studies demonstrated Prolensa to be superior to vehicle in the treatment of both inflammation and pain
`following cataract surgery. Twice as many patients as vehicle (46 percent versus 20 percent) demonstrated complete
`clearance of inflammation (SOIS of 0) at day 15. The difference in the average post-operative inflammation severity between
`the treatment and vehicle arms was statistically and clinically significant by day eight. Nearly four of five patients treated with
`Prolensa were pain free at day one (78.8 percent versus 49.5 percent for vehicle; p<0.0001). Patients treated with Prolensa
`reported a lower incidence of foreign body sensation and photophobia and had less redness than those treated with vehicle.
`
`"Bausch + Lomb is committed to delivering innovative therapeutic options to eye care professionals and the patients they
`serve, and the advanced formulation used for Prolensa embodies that commitment," said Dan Wechsler, executive vice
`president and president, Bausch + Lomb Global Pharmaceuticals. "We look forward to bringing this next evolution of the
`groundbreaking bromfenac franchise to our customers very soon."
`
`beginning one day prior to surgery, continued on the day of surgery, and
`
`Prolensa Dosage and Administration
`
`Instill one drop into the affected eye once daily
`through the first 14 days post surgery.
`
`Important Risk
`
`Information about Prolensa
`
`• Sulfite allergic reactions
`• Slow or delayed healing
`• Potential for cross-sensitivity
`• Increased bleeding of ocular tissues
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`• Corneal effects, including keratitis
`• Contact lens wear
`Adverse Reactions
`
`The most commonly reported adverse reactions in three – eight percent of patients were, anterior chamber inflammation,
`foreign body sensation, eye pain, photophobia, and blurred vision.
`
`About Bausch + Lomb
`Bausch + Lomb is a leading global eye health company that is solely focused on protecting , enhancing, and restoring
`people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and
`ophthalmic surgical devices
`and instruments. We globally develop, manufacture and market one of the most comprehensive
`product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is
`headquartered in Rochester, NY, and employs more than 11,000 people worldwide.
`
`Prolensa™ is a trademark of Bausch & Lomb Incorporated or its affiliates.
`
`News Media Contacts:
`
`Global Pharmaceutical Communications, Bausch + Lomb
`(973) 360-6382 or teresa.panas@bausch.com
`
`Tad Heitmann
`BioComm Network on behalf of Bausch + Lomb
`(714) 273-2937 or theitmann@BioCommNetwork.com
`
`Posted: April 2013
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`Prolensa (bromfenac) FDA Approval History
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