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B+L receives approvals


B+L has received FDA approval for bromfenac ophthalmic solution eye drops (Prolensa), CE mark for the Victus femtosecond laser platform for creation of corneal incisions in cataract surgery, and recommendation of approval for the Trulign Toric posterior chamber IOL.


Rochester, NY-Bausch + Lomb (B+L) announces that the FDA has approved the company’s new drug application (NDA) for bromfenac ophthalmic solution 0.07% prescription eye drops (Prolensa), a 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. The solution will be available in 1.6-ml and 3-ml bottle sizes.

The solution provides powerful and rapid resolution of inflammation and pain by leveraging the potency of the bromfenac molecule in a formulation designed to facilitate ocular penetration. The formulation allows for a lower concentration of bromfenac in a once-daily dosing regimen. The solution also does not require shaking to deliver a consistent dose in each drop.

In other news from B+L, the Victus femtosecond laser platform has received the CE mark in the European Union for the creation of corneal incisions in patients undergoing cataract surgery, as well as for penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments. The platform, offered by B+L Technolas, now has CE mark for all critical steps of laser-assisted cataract surgery, including capsulotomy, lens fragmentation, and corneal incisions.

An FDA advisory panel has recommend approval of B+L’s Trulign Toric posterior chamber IOL for patients who have had a cataract removed and would like to, without glasses, have improved distance vision and reduced residual refractive cylinder.

The toric lens is intended for implantation in the capsular bag of the eye in adult patients to correct aphakia and postoperative refractive astigmatism, according to the FDA.

For more articles in this issue of Ophthalmology Times eReport, click here.

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