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Bausch Health Licenses Dry Eye Disease Investigational Treatment

NOV03 showed statistically significant and clinically meaningful improvement in a variety of symptoms over the entire duration of the trial.

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(PRESS RELEASE) LAVAL, QUEBEC, and HEIDELBERG, GERMANY – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Bausch + Lomb, its leading global eye health business, and Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that Bausch Health has acquired an exclusive license for the commercialization and development in the United States and Canada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).

NOV03 is a proprietary water-free, preservative-free solution based on Novaliq’s patented EyeSol0 technology. DED is a chronic and serious disease of the ocular surface that can negatively impact quality of life1. In a Phase 2 study, NOV03 met its primary sign endpoint of improvement of total corneal fluorescein staining over control at eight weeks with high statistical significance (p<0.001). In addition, NOV03 showed statistically significant and clinically meaningful improvement in a variety of symptoms over the entire duration of the trial. A Phase 3 study is underway for NOV03, and Bausch Health anticipates starting an additional Phase 3 study in 2020.

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“Bausch Health remains focused on boosting our core businesses, and the addition of this investigational treatment for Dry Eye Disease will help build upon our strong Bausch + Lomb portfolio of integrated eye health products,” said Joseph C. Papa, chairman and CEO of Bausch Health. “It is estimated that more than 16 million patients in the United States are diagnosed with Dry Eye Disease2, and if approved,
NOV03 will be the first pharmaceutical therapy available for patients in the United States suffering from Dry Eye Disease with Meibomian gland dysfunction.”

“We are thrilled to partner with Bausch + Lomb who is a leader in the ophthalmic space with a strong commercial footprint in the United States and is also very committed to developing innovative new eye health products,” said Christian Roesky, Ph.D., CEO of Novaliq. “As part of Bausch + Lomb’s portfolio, we believe that NOV03 will help address the unmet medical need of millions of patients suffering from Dry Eye Disease.”

Under the terms of the licensing agreement, Novaliq is eligible to receive upfront and milestone payments based on regulatory and commercialization milestones, and sales royalties based on annual net sales of NOV03 in the United States and Canada.

Bausch Health has the right to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada. Novaliq will be eligible to receive additional undisclosed milestone payments plus royalties for any resulting combination products.

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OGI Announces the Appointment of David Duralde as Chief Creative Officer

He will not only lead creative development but will also serve as partner.

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(PRESS RELEASE) OGI Eyewear, a member of The Optical Foundry, announces the appointment of David Duralde as chief creative officer. Duralde has joined the company not only to lead creative development but also as a partner.

Duralde’s distinguished optical career is marked by extensive experience both with licensed and independent brands, including his most recent role as Chief Creative Officer at Kenmark Eyewear. “I am very excited about the opportunity to redefine and reinvigorate the niche independent brands in the OGI portfolio of products and provide a consistent, compelling story to the brands. I can’t wait to get started with the OGI
Eyewear product and marketing teams to connect deeply with our loyal customers, create frames that light up many more faces and help independent practices thrive and shine in this vigorously changing market.” said Duralde.

Robert Rich, CEO of OGI, notes, “David is exactly the right person to lead us in the revitalization of our brand portfolio. Despite a solid market position, OGI and its family of brands will benefit from an injection of fresh ideas and design innovations that will expand our leading role in the realm of affordable luxury frames.”

Rich adds, “This is a homecoming of sorts for David, having begun his formative optical design training at l.a.Eyeworks, another member of the Optical Foundry.”

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First US Patient Gets Wireless Retinal Device Implant

It’s aimed at restoring partial sight to patients with advanced age-related macular degeneration.

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(PRESS RELEASE) PITTSBURGH – UPMC has implanted the first patient in the U.S. with a new wireless retinal device as part of a clinical trial aimed at restoring partial sight to patients with advanced age-related macular degeneration.

“Vision research has advanced dramatically in the recent past and UPMC is at the forefront of this revolution. This is the first of many such breakthroughs led by UPMC and Pitt that will benefit patients with vision loss in our community and around the world,” said José-Alain Sahel, MD, director of the UPMC Eye Center, Eye and Ear Foundation chair of ophthalmology and distinguished professor at the University of Pittsburgh School of Medicine who initiated the trial at UPMC. “We are proud to be the first center in the United States to test this next generation retinal implant that could help treat an incurable disease like AMD.”

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The system, called PRIMA, is designed to restore sight in patients blinded by retinal degeneration. It consists of a 2 millimeter-by-2 millimeter, 30-micron thick miniaturized wireless photovoltaic chip placed under the damaged retina. It works in tandem with augmented reality glasses that have a built-in miniaturized camera and infrared projector.

The chip acts like a tiny artificial retina, made up of 378 tiny electrodes that convert infrared light from the glasses to electrical signals that are carried by the optic nerve to the brain. After receiving the implant, patients undergo an intensive rehabilitation program that trains their brains to understand and interpret the signals from the implant in combination with their remaining natural vision. Compared to earlier-generation implants, PRIMA is wireless and has significantly more electrodes, which allows for the transmission of more visual information.

“This is an incredibly exciting first for us at UPMC and I’m honored to be a part of it,” said Joseph Martel, MD, the implanting surgeon at the UPMC Eye Center and the Pitt School of Medicine, and the principal investigator of the trial at UPMC. “I’m grateful to our patients who have volunteered to participate in this trial, without whom this would not be possible.”

AMD is the leading cause of vision loss in people older than 50. Today, it affects approximately 14 million people in the United States, and the prevalence is expected to rise as the baby boomers age. As AMD progresses, the center of vision becomes increasingly blurry. “Atrophic” AMD, which accounts for a large proportion of advanced cases, has no curative treatment available.

The UPMC feasibility trial is running in parallel with the first-in-human trial in France, which involves five patients with advanced AMD, who now have been followed for more than a year. The 12-month results from the French study demonstrated the ability of most patients to identify sequences of letters and there were no device-related serious adverse effects.

“We are working with a great sense of urgency because the aging population of the United States, especially the western Pennsylvania region we live in, will see a significant rise in the number of patients at risk for vision loss through diseases like age-related macular degeneration, glaucoma and vascular eye disease, as well as earlier onset genetic conditions such as retinitis pigmentosa,” said Sahel. “This is why our physicians and researchers at UPMC and Pitt, in collaboration with our U.S. and international colleagues — especially at the Paris Vision Institute at Sorbonne University — are taking a multi-pronged effort to treat and rehabilitate patients with vision impairments.”

In March 2019, UPMC broke ground on the UPMC Vision and Rehabilitation Tower at UPMC Mercy, which when completed, will provide advanced specialty clinical care and innovative programs for visually impaired patients. It also will be the home for the vision research program at Pitt and UPMC.

The PRIMA implant was invented by Daniel Palanker, professor of ophthalmology at Stanford University, and licensed and developed by Pixium Vision, a spin-off from the Paris Vision Institute. Sahel is a co-founder of Pixium and holds shares in the company.

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There Might Be a Faster and Cheaper Way to Test for Myopia

The research comes from Flinders University in Australia.

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(PRESS RELEASE) Myopia could become significantly easier to assess, according to a group of scientists.

Progressive research at Flinders University in Australia has identified a new method to measure how it affects the eye, a new article in PLOS ONE reveals.

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The work was based on testing of 70 volunteers, with the Flinders ophthalmology and medical device research institute experts taking a novel approach with optical coherence tomography (OCT), a device already available in most optometric and all ophthalmic practices.

“Our work uses the OCT and finds irregularities at this scale that correlate with the size of the eye, and therefore the degree of myopia,” says eye specialist Dr. Stewart Lake, from Flinders University.

“This may help monitor, measure, and explore the effects of myopia and how it leads to vision loss,” he says, adding that further development could make the system suitable for use in regular clinical practice.

Prior research elsewhere with MRI scanning has demonstrated large scale irregularities in the eyeball in highly myopic eyes.

OCT can sample the shape of the eye on a much smaller scale than MRI. The OCT testing will be far cheaper, is more readily available and repeatable as a test, researchers say in the article.

Myopia (short or near-sightedness) is for many an inconvenience requiring glasses or contact lens to correct. However, globally it is an epidemic and a major cause of vision loss and sometimes blindness.

Myopia is defined practically by the strength of lens required to correct eyesight. It was already known that myopia relates strongly to the size/length of the eyeball.

Global estimates forecast up to 5 billion people will have myopia and 1 billion people could suffer with high myopia by 2050, placing a significant burden on health systems to manage and prevent myopia-related ocular complications and vision loss.

This seven-fold increase, between 2000 and 2050, would make myopia the leading cause of permanent blindness worldwide.

High myopia increases the risk of pathological ocular changes such as cataract, glaucoma, retinal detachment and myopic macular degeneration, all of which cause irreversible vision loss

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