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FDA Approves B+L Eye Surgery Drug

It treats postoperative inflammation and pain.

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BRIDGEWATER, NJ — Bausch + Lomb announced that the U.S. Food and Drug Administration has approved Lotemax SM 0.38%, a gel formulation for the treatment of postoperative inflammation and pain following ocular surgery.

Compared to Lotemax Gel 0.5%, Lotemax SM (loteprednol etabonate ophthalmic gel) delivers a submicron particle size for faster drug dissolution in tears, according to a press release from the company. Lotemax SM also provides two times greater penetration to the aqueous humor compared to Lotemax Gel.

“With the FDA approval of LOTEMAX SM, physicians can now prescribe to their patients our most advanced loteprednol etabonate formulation to date, indicated for the treatment of postoperative inflammation and pain following ocular surgery,” said Joe Gordon, U.S. president, Bausch + Lomb.

“Since Bausch + Lomb introduced the first formulation of loteprednol etabonate more than 20 years ago, we have continued to advance formulations that meet the changing needs of our patients. We are planning to make LOTEMAX SM available as a new treatment option for patients by April 2019.”

“Patients undergoing ocular surgery, including cataract surgery, often experience inflammation that needs to be treated. This inflammation can be painful and result in serious complications,” said Dr. Marguerite McDonald, ophthalmologist and clinical professor of ophthalmology, New York University School of Medicine.

“In two clinical trials, LOTEMAX SM was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery, one of the most common operations performed in the United States.

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“LOTEMAX SM provides proven efficacy, efficient penetration, and less frequent dosing compared to LOTEMAX GEL, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule. Together these factors support LOTEMAX SM as an important new option for many of my patients who require treatment for inflammation and pain following ocular surgery.”

Since launching in 2014, INVISION has won 21 international journalism awards for its publication and website. Contact INVISION's editors at editor@invisionmag.com.

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Chain Retailer to Close All Stores, Evaluate Options for Optical Business

The company was unable to find a buyer.

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GREEN BAY, WI — Retail chain Shopko announced that it will wind down its operations and that it is “evaluating strategic options” for its optical business.

The company said in a press release that despite its best efforts, it was “unable to find a buyer for its go-forward business as a going concern.”

“As a result, Shopko will commence an orderly wind-down of its retail operations beginning this week,” the company stated.

USA Today reports that Shopko announced in February its intent to close 250 stores, which would amount to 70 percent of its locations. That plan came as the company “attempted to scale back the business and work through bankruptcy to restore profitability and attract a buyer or investor,” according to the newspaper.

Now, the company instead plans to close all stores by mid-June, USA Today reports.

The company will not move forward with the auction that it previously contemplated, and Gordon Bros. will oversee a liquidation process that is expected to conclude 10 to 12 weeks from now, according to the release.

“This is not the outcome that we had hoped for when we started our restructuring efforts,” said Russ Steinhorst, CEO. “We want to thank all of our teammates for their hard work and dedication during their time at Shopko.”

As for the optical business, Shopko had originally hoped to spin off the business into standalone locations, USA Today reports.

Now the optical business will be among the assets that Shopko seeks to liquidate, according to the newspaper.

WLUK-TV reports: “As of now, four Shopko optical locations will remain open until further evaluation: Mequon, Oshkosh, Waukesha and Omaha, Nebraska.”

In its Jan. 16 bankruptcy filing, Shopko reported having less than $1 billion in assets and between $1 billion and $10 billion in liabilities.

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Alcon Makes $285M Acquisition

It bought PowerVision Inc., a medical device development company.

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FORT WORTH, TX – Alcon announced that it has acquired PowerVision Inc., a privately held, U.S.-based medical device development company focused on creating fluid-based intraocular lens implants.

Alcon paid $285 million to PowerVision at closing, with additional payments to be made based on regulatory and commercial milestones starting in 2023, according to a press release from Alcon, a division of Novartis.

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The acquisition “furthers Alcon’s commitment to bring this innovative, accommodating lens to cataract patients throughout the world,” the release stated.

Financial terms of the deal were not disclosed.

Commercial availability of PowerVision’s IOL technology will be determined following significant additional development and clinical trials of the intraocular lens, according to the release.

“As the industry leader in cataract surgery, we’re eager to accelerate development of this potentially breakthrough accommodating lens technology,” said Michael Onuscheck, president of Global Business and Innovation. “By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence.”

PowerVision’s lens design utilizes the eye’s natural accommodating response to transport fluid in the intraocular lens which is implanted in the eye’s capsular bag.

While most presbyopia-correcting intraocular lenses use a multifocal design that distributes light between different focal points, PowerVision’s fluid-based design creates a continuously variable monofocal lens, utilizing the natural contraction of the eye’s muscles, according to the release. This technology allows the patient to actively focus on objects, just as the natural crystalline lens does in a youthful eye, providing patients with a natural, continuous range of vision.

“We’re thrilled to officially join Alcon and its pioneering history of launching new innovation in the field of ophthalmology,” said Barry Cheskin, president and CEO and co-founder of PowerVision. “We look forward to bringing this innovative IOL technology to eye care providers and customers in the years ahead.”

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Marchon Eyewear Co-Founder Dies

Alfred Berg was 67.

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Alfred Berg, who co-founded Marchon Eyewear in 1983, has died, WWD reports.

He was 67.

In the beginning, Berg served as CEO and president of Marchon. In 2008, Berg and partners sold Marchon to VSP Global.

Berg “left an incredible legacy behind, having built one of the world’s greatest and largest eyewear companies, which still thrives today thanks to his vision and competitive spirit,” said Rob Lynch, board member of VSP Global, according to WWD. Lynch was leading the company when it bought Marchon.

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Nicola Zotta, current CEO of Marchon, was quoted saying, “Al will be greatly missed by all who knew him and we will honor his legacy by continuing to make Marchon the most admired global eyewear company in the world.”

Among Marchon’s licenses today are Calvin Klein and Chloé.

Read more at the WWD

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