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Bausch + Lomb Announces Results from First Phase 3 Trial of NOV03

Bausch + Lomb and Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced statistically significant topline data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

The GOBI trial met both of its co-primary endpoints, including:

  • Change from baseline in total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the eye, achieved statistical significance at day 15 (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control;
  • Change from baseline in dryness score achieved statistical significance at day 15 (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control, as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort).

The GOBI trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied.

“There is currently no pharmaceutical therapy available in the United States for the treatment of dry eye disease associated with meibomian gland dysfunction,” said Yolande Barnard, vice president and general manager, U.S. Pharmaceuticals, Bausch + Lomb. “These outstanding topline results are very encouraging that we may be able to bring this first-in-class treatment option to market for the millions of patients who have dry eye disease associated with meibomian gland dysfunction.”

“I am very impressed by the positive results from this first Phase 3 study of NOV03, in particular the findings at day 15 in treating the signs and symptoms of the disease,” said Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and trial investigator. “These findings validate the importance of the continued development of NOV03, and I look forward to seeing additional results from the Phase 3 program.”

The Phase 3 program for NOV03 includes an ongoing second Phase 3, multi-center, randomized, double-masked, saline-controlled trial (MOJAVE study) and a multi-center, open-label, single-arm 12-month safety extension trial (KALAHARI study). Topline results from MOJAVE, if positive, will allow for a filing to the U.S Food and Drug Administration in 2022.

Click HERE for the full press release.

Related:
Bausch Advances Novel Dry Eye Therapeutic to Phase 3

Gene Therapy Approach to Regenerate Damaged Optic Nerves

Fighting Blindness Canada research

Scientists from the University of Cambridge have used gene therapy to regenerate damaged optic nerves in the eyes of mice, offering hope that this information could help in the development of new treatments for glaucoma.

The optic nerve isn’t normally able to heal once it is damaged, however research in the last few years has shown that it may be possible to stimulate nerves to regenerate.

In this study published in the journal Nature Communications, scientists used a gene therapy approach to get nerve cells to make higher amounts of a protein called Protrudin. What they saw was that after optic nerve damage, nerve cells that were making more Protrudin were able to regrow the nerve, while cells without gene therapy didn’t regenerate.

Carl Zeiss Vision Canada and WestGroupe announce donation to Optometry Giving Sight

Carl Zeiss Vision Canada and WestGroupe, through their sales in ValuePak Frame and Lens packages have donated over $110,000 to Optometry Giving Sight since 2016.

ValuePak offers frames from WestGroupe and synchrony® lens from Carl Zeiss Vision Canada.

“We are proud of our achievement together in partnership with WestGroupe and Optometry Giving Sight” said Bryan Rossi, President at Carl Zeiss Vision Canada. “One of our corporate pillars is sustainability, including social and green responsibility. We express our gratitude that we are able to offer support to those who are in need of eye care around the world.”

Michael Suliteanu, President, WestGroupe, said, “We cherish the opportunity to give back through our partnership with Carl Zeiss Vision, whereby a portion of every pair we sell is donated to such a significant initiative.  Optometry Giving Sight not only reflects the value we place on sustainability and responsibility, but furthermore the humanistic duty that informs our industry—to provide sight and, consequently, quality of life to all.”

More information on the program is available on the ZEISS and WestGroupe websites.

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WCO Passes Resolution Calling for Standard of Care for Myopia Management

Furthering its commitment to address the global epidemic of childhood myopia, the World Council of Optometry (WCO) Board of Directors unanimously approved a resolution advising optometrists to incorporate a standard of care for myopia management within their practices.

“Myopia is increasing at an alarming rate, as are the risks for vision impairment associated with the condition. With more than five billion people projected to be affected by myopia by 2050, the global optometric community must increase its efforts to combat this public health issue,” said Paul Folkesson, president, World Council of Optometry.

The resolution defines the evidence-based standard of care as comprising of three main components:

  • Mitigation — optometrists educating and counseling parents and children, during early and regular eye exams, on lifestyle, dietary, and other factors to prevent or delay the onset of myopia.
  • Measurement — optometrists evaluating the status of a patient during regular comprehensive vision and eye health exams, such as measuring refractive error and axial length whenever possible.
  • Management — optometrists addressing patients’ needs of today by correcting myopia, while also providing evidence-based interventions (e.g., contact lenses, spectacles, pharmaceuticals) that slow the progression of myopia, for improved quality of life and better eye health today and into the future.

It also advises optometrists to incorporate within their practice the standard of care for myopia management, which shifts from simply correcting vision to managing the condition, and also includes public education and early, frequent discussions with parents that explain:

  • What myopia is.
  • Lifestyle factors that may impact myopia.
  • The increased risks to long-term ocular health that myopia brings.
  • The available approaches that can be used to manage myopia and slow its progression.

The standard of care resolution can be found in its entirety on the World Council of Optometry’s website, here.

WCO and CooperVision recently announced a global partnership to raise awareness of myopia progression and encourage optometrists to embrace a standard of care to manage the condition. The partnership will establish a global resource to include multi-lingual myopia management resources and programming that currently have not been widely accessible or actively addressed in certain sectors or countries. 

Click HERE for the full press release.

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