Ophthalmology Times Staff Reports

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Deirdre Waterman, MD, explains why she left ophthalmology practice after nearly 30 years to run for public office. 
Today, she is a second-term Mayor of the City of Pontiac, Michigan. Dr. Waterman touches upon healing a community amid the novel coronavirus pandemic and with protests across the nation in this interview with Sheryl Stevenson, group editorial director of 

Returning to the new 'norm' of ophthalmic practice

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Bausch + Lomb today announced that the FDA has approved its ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.

According to Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, an OVD is a key component in ophthalmic surgery, and “ClearVisc offers surgeons unique advantages that are designed to contribute to surgical safety and effectiveness and to enable positive outcomes.”

“We are excited to bring forward this latest advancement in OVDs to help address the unmet needs of our customers and their patients,” he said in a statement.

According to Bausch + Lomb, the new OVD contains Sorbitol, which is a unique chemical agent that has been shown in a laboratory study to deliver superior free radical protection compared to other dispersive OVDs.1,2

Free radicals form as a result of chemical reactions caused during phacoemulsification, irrigation/aspiration and as part of the insertion and removal of instruments and implants. Free radicals can contribute to corneal damage and possible decompensation, which can lead to post-surgical complications such as a cloudy cornea. ClearVisc helps provide physical protection of the cornea from thermal and mechanical damage as well as chemical protection from damaging free radicals.

According to the company, a multicenter, randomly assigned clinical study of 372 subjects showed that ClearVisc met its primary safety and efficacy endpoints. No serious adverse events were seen with ClearVisc eye surgeries.

The study also found that clear corneas were seen in 91% of eyes for ClearVisc and 92% of eyes for VISCOAT at 1-day post-operative and in 100% of eyes for ClearVisc and 98% of eyes for VISCOAT at 1-week post-operative.1

John Berdahl, MD, clinician and researcher, Vance Thompson Vision, Sioux Falls, SD, and ClearVisc clinical trial investigator, noted that the dual protection provided by ClearVisc helps to ensure protection of the cornea as well as positive surgical outcomes.

“In my experience as an investigator, I was pleased with the level of control and safety that ClearVisc delivered throughout the procedure,” he said in a statement.

ClearVisc helps to ensure tissue visualization, maintains anterior chamber space throughout all phases of lens removal and IOL insertion and is easily removed during irrigation/aspiration.1 ClearVisc is also supplied in a 1.0 ml syringe, which reduces the need to open a second pack mid-procedure.1

Data on File. Bausch & Lomb Incorporated, 2021.

Francesco Maugeri, Adriana Maltese, Keith W. Ward & Claudio Bucolo (2007). Hydroxyl Radical Scavenging Activity of a New Ophthalmic Viscosurgical Device, Current Eye Research, 32:2, 105-111, DOI:10.1080/02713680601147716.

American Academy of Ophthalmology. Retrieved from 

https://www.aao.org/eye-health/diseases/what-are-cataracts

U.S. Centers for Disease Control and Prevention Web site, Vision Health Initiative (VHI). Retrieved from 

https://www.cdc.gov/visionhealth/basics/ced/index.html#:~:text=external%20icon-,Cataract,can%20be%20present%20at%20birth

American Academy of Opthalmology. Retrieved from 

https://www.aao.org/eye-health/diseases/what-is-cataract-surgery

National Eye Institute Website. Retrieved from 

https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/cataracts/cataract-surgery

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Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device has received FDA approval for use in ophthalmic surgery. 

FDA approves OVD for use in ophthalmic surgery


The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis, Kala Pharmaceuticals Inc.) for the signs and symptoms of dry eye disease.

In a statement, Mark Iwicki, chairman, president and CEO of Kala Pharmaceuticals, noted that the “FDA approval of EYSUVIS as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy.”

Approximately 80 percent of people living with dry eye disease suffer from episodic flares. In a release Kala said these flares can be caused by a wide variety of triggers and often cannot be adequately managed with current therapies.

Kala Pharmaceuticals announced it plans to launch Eysuvis in the United States by year-end as a treatment for the temporary relief of the signs and symptoms of DED utilizing a two-week course of therapy. 

The LE 0.25% suspension is formulated with a proprietary mucus-penetrating particle drug delivery technology (AMPPLIFY) that improves bioavailability of the active ingredient at the target site. LE targets the immune responses that drive acute dry eye disease flares. Prior to Eysuvis, there were no FDA-approved ocular corticosteroids for the treatment of dry eye disease.

According to Edward Holland, MD, director of Cornea Services at Cincinnati Eye Institute and professor of ophthalmology at the University of Cincinnati, the approval of Eysuvis “ushers in a new era in the treatment of dry eye disease and offers promise to the millions of dry eye patients who experience acute exacerbations, or flares, of their disease each year.”

“For the first time we will be able to offer dry eye patients a therapeutic option that provides rapid relief for both the signs and symptoms of the disease and that is safe and well tolerated,” he said in a release.

Kelly Nichols, OD, MPH, PhD, FAAO, dean of the University of Alabama at Birmingham School of Optometry, noted in the release that dry eye disease can significantly decrease quality-of-life among affected patients and drive decreased workplace productivity, contact lens intolerance and discontinuation, and poor cataract and refractory surgery outcomes.

“As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated,” she said in the release. “I am excited by the approval of EYSUVIS and confident that having access to an approved corticosteroid specifically for dry eye disease will meaningfully impact the management of patients across the US.”

According to the release, the FDA granted approval to EYSUVIS based on results of several studies, including three Phase 3 trials and one Phase 2 trial. The company pointed out that the trials demonstrated improvements in both the signs and symptoms of dry eye disease.

Instillation site pain was the most common adverse event, which was reported in 5% of patients

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% for short-term treatment of the signs and symptoms of dry eye disease. 


FDA approves topical corticosteroid for treatment of dry eye disease

Bausch Health Companies Inc. (BHC) announced in a prepared statement today its decision to spin off its eye health business into an independent publicly traded company, Bausch & Lomb-NewCo, that will be separate from the other Bausch Health entities.

By so doing, BHC anticipates a number of benefits from this action, namely, unlocking value in the Bausch + Lomb brand and integrated portfolio of eye health products, facilitating BHC focus on expanding leadership in gastroenterology, aesthetics/dermatology, neurology, and international pharma, and enhanced focus on and highlighting of two attractive but dissimilar businesses, according to the statement.

This action, according to BHC will result in 2 separate companies, specifically, a fully integrated, pure play eye-health company built on the iconic Bausch + Lomb brand and long history of innovation; and a diversified pharmaceutical company with leading positions in gastroenterology, aesthetics/dermatology, neurology and international pharmaceuticals.

Bausch & Lomb said it anticipates that this action will “improve strategic focus and enhance financial transparency to better enable stakeholders to value each business independently.”

"We are committed to taking action to unlock what we see as unrecognized value in Bausch Health shares, and we believe that separating our business into two highly focused, stand-alone companies is the way to accomplish that goal," said Joseph C. Papa, chairman and CEO of Bausch Health.

Four years ago, the organization initiated a multiphase plan, first to stabilize and then to transform Bausch Health into a company positioned to deliver long-term organic growth, Papa noted.

“We have divested approximately $4 billion of non-core assets, paid down over $8 billion of debt, resolved numerous legacy legal issues and managed a loss of exclusivity on an approximately $1.4 billion product portfolio, while also investing in R&D, new product launches­­ and core franchises with attractive growth opportunities,” he continued. “Our Board of Directors and management team have been working on alternatives over the last 12 months to determine how to best unlock value across our businesses, and we believe that the time is right to begin the separation process, so each business has greater flexibility to pursue strategic opportunities in their respective markets."

It is anticipated that after satisfying certain conditions and approvals and completion of other actions, reporting is expected to begin in the first quarter of 2021.

Bausch + Lomb - NewCo, will include Bausch Health's global vision care, surgical, consumer and ophthalmic Rx businesses. The company explained that the combination of pipeline expansion and established durable eye care brands, including BAUSCH + LOMB ULTRA, Biotrue ONEday, LUMIFY, Ocuvite and PreserVision, among others, and the launch of BAUSCH + LOMB INFUSE contact lenses, is expected to drive what is expected to be consistent revenue growth worldwide.

BHC will include a diversified portfolio of leading durable brands across the Salix, International Rx, Solta, neurology and medical dermatology businesses. Core products include XIFAXAN, TRULANCE and RELISTOR for gastrointestinal diseases; JUBLIA, DUOBRII and Thermage FLX for dermatologic conditions; and WELLBUTRIN and APLENZIN for neurological conditions.

This action will result in 2 separate companies,

Ophthalmology Times Staff Reports

Articles

FDA approves OVD for use in ophthalmic surgery

FDA approves topical corticosteroid for treatment of dry eye disease

Bausch Health: Spin-off of eye health business

Ophthalmologist-Mayor Deirdre Waterman on healing a community amid pandemic, protests