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Geographic Atrophy: An Update on Two Clinical Trials

Fighting Blindness Canada

This month, Fighting Blindness Canada is sharing clinical trial updates on two potential treatments for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD). There are currently no approved treatments for GA in Canada.

Alkeus announced the results from their Phase 3 Saga study of an oral drug called gildeuretinol acetate (ALK-001) for patients with GA. Patients taking the daily drug showed a reduction in growth of the GA lesion compared to a placebo. However, the difference wasn’t large enough to be considered significant. Despite this, the company is optimistic about the results, especially as this is the first oral drug to show any impact on GA. Alkeus will be talking to regulatory agencies (e.g. FDA) to determine if there is a path to bring the treatment to patients.

Galimedix announced the launch of a Phase 2 study (eDREAM), testing an eye drop (GAL-101) to treat GA. The trial will compare the effect of the GAL-101 eye drops with a placebo. The trial will enroll up to 110 patients and researchers will observe if the drops slow the growth of the GA lesion. GAL-101 is also being studied for treatment of glaucoma and Alzheimer’s disease.

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WCO Launches Updated “Why Optometry” Document to Address Global Vision Crisis

World Council of Optometry

This World Optometry Day, the World Council of Optometry (WCO) announces the release of its newly revised Why Optometry document, aimed at tackling the growing global vision crisis and reinforcing optometry’s role in public health. With at least 2.2 billion people worldwide affected by vision impairment— one billion of whom suffer from preventable or untreated conditions— this report provides a compelling roadmap for integrating optometry into healthcare systems worldwide.

A Call to Action for Eye Health Accessibility

Why Optometry outlines the urgent need for accessible eye care and the crucial role that optometrists play in addressing vision impairment. The document serves as a call to action for healthcare policymakers, regulators, and stakeholders to prioritize eye health as a fundamental component of universal healthcare by strengthening optometry education, legislation, and workforce expansion.

“With the release of the World Health Organization’s World Report on Vision in 2019, a spotlight was put on the global problem of visual impairment. The Why Optometry document showcases how optometrists have a primary role in eye care, in addition to the appropriate skills and clinical knowledge to address this global issue,” says Dr. Michelle Piotrowski, lead author of the Why Optometry document.

“The projected increase in devastating eye diseases such as glaucoma, diabetic retinopathy and macular degeneration means health systems need to integrate optometry effectively in order to enhance the accessibility and affordability of eye care worldwide.”

Bridging the Gap in Global Eye Care

The Why Optometry document highlights disparities in eye care access, particularly in low-income and rural communities, where a lack of trained professionals and financial barriers leave millions without essential services. With evidence-based strategies, WCO’s latest publication urges governments and organizations to enhance regulatory frameworks, invest in optometry education, and integrate optometrists into primary healthcare settings.

Key recommendations from Why Optometry include:

  • Expanding optometry education and competencies to strengthen the global workforce.
  • Advocating for legislative and regulatory advancements to support optometry’s role in healthcare systems.
  • Promoting optometry-led initiatives to improve early detection and treatment of common eye diseases.
  • Encouraging collaboration between private and public healthcare sectors to enhance service delivery.

“This document is an easy read for policymakers, regulators, and administrators to help them better understand the scope of what optometry does and the importance of being part of the healthcare team,” says Dr. Roger Jordan, WCO Legislation, Registration, and Standards (LRS) Committee Chair. 

The World Health Organization (WHO) has recognized vision care as a critical component of public health. The Why Optometry document aligns with WHO’s World Report on Vision and the United Nations’ Sustainable Development Goals, reinforcing optometry’s essential role in achieving universal eye health coverage by 2030.

WCO invites policymakers, healthcare providers, and the public to engage with the insights of Why Optometry and advocate for the implementation of its recommendations. The full document is now available for download at worldcouncilofoptometry.info/resources.

Click HERE for the press release.

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The Trade Tariff Dance Begins Again

The Trade Tariff Dance Begins Again Jan-Feb Optik 2025

By Jean-François Venne

This article was originally published in the January-February 2025 issue of Optik Magazine.

Donald Trump has threatened to significantly increase trade tariffs on Chinese imports and impose a 25% surcharge at the border on Canadian products. This could have wide-reaching implications for North America’s optical industry.

Karl Marx is often credited with saying, “History doesn’t repeat itself, but it often rhymes.” That sentiment resonates as Donald Trump, freshly re-elected, revisits the aggressive trade tariffs that marked his first term. The optical industry was not spared in the past. In 2019, his administration imposed tariffs of 10% to 25% on a range of Chinese imports, including eyeglass frames, ophthalmic lenses, sunglasses, cases, and cleaning solutions.

“This time, Trump is threatening tariffs as high as 60%, which has our members worried—especially since certain materials, such as cellulose acetate, are not competitively available in the U.S.,” says Omar Elkhatib, Senior Director of Government Affairs at The Vision Council.

25% Tariffs and Counting

Historically, Chinese optical products were subject to tariffs of 2% to 2.5%. “Since Trump’s initial presidency, these rates have averaged between 7% and 7.5%. Some items, such as eyeglass cases, cleaning solutions, and frame-making equipment, are now taxed at 25%,” Elkhatib explains.

In Canada, ophthalmic frames have so far escaped this tariff war. However, Chinese-made sunglasses face a 5% duty, and this could change. Pierre Poilievre, the Conservative Party leader who currently enjoys a commanding lead in polls, has repeatedly stated that Canada should align its tariff policies with the U.S. when it comes to China.

In 2022, Canada imported over $76 million worth of plastic frames from China, compared to $46 million from Italy and just under $6 million from France, according to government data. Chinese sunglasses imports were valued at nearly $91 million, compared to $106 million for their Italian counterparts.

The “Made in USA” Path

The rise in trade tariffs, coupled with the pandemic’s impact on global supply chains, is pushing the optical industry to consider increasing production in North America. However, industry leaders argue that government support is essential for such a shift.

“We need tax incentives or financial support to bring more production back to the U.S.,” says Elkhatib. The Vision Council has also called on the U.S. government to relax its criteria for what qualifies as “Made in the USA.”

A 2024 report by The Vision Council found that half of consumers believe frames assembled in the U.S. with imported materials should qualify as “Made in the USA.” Current laws, however, prohibit such labeling. The report also reveals that nearly half of consumers are willing to pay 5% more for frames made domestically.

Risks for Canada

New American tariffs on Chinese and Canadian imports could affect Canada’s optical industry in multiple ways. “The North American optical supply chain is highly integrated, with products flowing back and forth between the U.S. and Canada. The industry also relies heavily on imports from China,” says Michel Rochette, President of the Retail Council of Canada (RCC) in Quebec.

Some Canadian companies import frames, materials, and other products from China through U.S.-based warehouses. This is especially true for businesses with operations on both sides of the border. However, these goods are subject to U.S. tariffs on Chinese imports.

There is also the risk that the U.S. could impose tariffs on Canadian exports if they contain Chinese components. For example, frames designed in Canada but manufactured in China, or those assembled in Canada using Chinese materials, could be targeted.

A 25% tariff on Canadian exports to the U.S. would severely impact Canadian optical designers and distributors, many of whom rely on American clients. “It’s unclear whether this is a genuine threat or a tactic to force an early renegotiation of the Canada-United States-Mexico Agreement (CUSMA). Regardless, businesses must prepare for the worst,” Rochette warns.

Optik Jan Feb 2025 The Trade Tariff Dance Begins Again- graphic

Adapting to Uncertain Tariff Scenarios

Adjusting to potential tariff hikes—whether targeting Chinese or Canadian products—is no easy feat. “Some companies might explore sourcing alternatives outside of China or reconfigure their supply chains to avoid routing products through the U.S. Of course, part of the tariff increases is likely to be passed on to consumers through higher prices,” Rochette explains.

The greatest challenge, however, will be unpredictability. The return of Trump to the White House in January, combined with political instability in Canada, could create a volatile environment for Canadian retailers, including those in the optical sector.

**

Source for tariffs on Chinese optical imports to Canada (Chinese imports are subject to the MFN tariff): https://www.cbsa-asfc.gc.ca/trade-commerce/tariff-tarif/2025/html/00/ch90-eng.html#wb-auto-4

Source on the value of imports from China (sunglasses): https://ised-isde.canada.ca/app/ixb/cid-bdic/exportingCountries.html?hsCode=900410&countryCode=553

Source on the value of imports from China (plastic ophthalmic frames): https://ised-isde.canada.ca/app/ixb/cid-bdic/exportingCountries.html?hsCode=900311&countryCode=553

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NextGEN OD Canada 2025 Expands with Live Event to U.S. Optometry Schools

Future FOCUS form banner

The third annual NextGEN OD Canada event is set to take place on Wednesday, March 26, 2025, bringing together Canadian optometry students from across North America for an evening of insights, networking, and career-building opportunities.

This year, the event expands its reach, broadcasting live from the University of Waterloo’s Federation Hall and New England College of Optometry (NECO), and simulcast to other participating U.S. optometry schools.

NextGEN OD Canada is dedicated to supporting the next generation of Canadian optometrists by providing access to industry leaders, career resources, and essential discussions on the future of optometry in Canada. The event, starting at 5:30 PM local time in both Waterloo and Boston, will feature a keynote presentation by Dr. Jenny Lee (UW 2023), who will share her experiences and insights with students preparing to enter the profession.

At 7:00 PM (ET), the event will transition to a live Zoom simulcast, allowing students across North America to tune in for a dynamic expert panel discussion featuring Canadian Key Opinion Leaders (KOLs) in optometry. Panelists will share valuable perspectives on the Canadian optometric landscape, providing students with essential knowledge for their future careers.

In addition to expert discussions, registered attendees will have the chance to win exciting prizes, with a total prize pool exceeding $3,000!

Sponsors Supporting the Next Generation of Optometrists

NextGEN OD Canada 2025 is made possible through the generous support of leading industry organizations, including:

🔹 Visionary Sponsors: Eye Recommend, FYidoctors, OSI Group, and Specsavers
🔹 Horizon Sponsors: Vogue Optical, Clinical & Refractive Optometry, and ROI Corporation

Their commitment to fostering the growth and success of future optometrists ensures that students have access to invaluable learning and networking opportunities.

Event Details:

📍 Live Event Locations:

  • Federation Hall, University of Waterloo (Waterloo, ON)
  • New England College of Optometry (Boston, MA)
  • Additional participating optometry schools

🕠 Local Check-in: 5:30 PM (Waterloo & Boston)
🖥 Zoom Simulcast Begins: 7:00 PM (ET)

Optometry students are encouraged to register now for the ZOOM event and secure their spot at this must-attend event for future Canadian optometrists.

In addition to the March 26 event, a live event and rebroadcast is scheduled for April 3rd at 6 PM Pacific time to accommodate students in the western time zones. 

📌 Register Here: https://vuepoint.ac-page.com/Futurefocus-2025-ZOOM

For more information, please contact:

David Pietrobon

Eye Care Business Canada, Publisher
📧 Dpietrobon@vuepoint.ca
📞 226-780 6871 x 5111

Click HERE for the press release.

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B + L Announces Publication of Phase 4 Data on the Early Effects of MIEBO® on Patient-Reported Outcomes in Dry Eye Disease in Ophthalmology and Therapy Journal

Bausch + Lomb

Bausch + Lomb Corporation announced Ophthalmology and Therapy has published results from a phase 4 study which assessed early patient-reported outcomes with MIEBO in patients with dry eye disease (DED). MIEBO, indicated for the signs and symptoms of DED, is the first and only prescription treatment to directly target tear evaporation. These results shed light on the benefits of MIEBO after the first use and during the first two weeks of treatment. These data build on results from the GOBI and MOJAVE pivotal studies in which patients experienced significant improvement in the signs and symptoms of DED as early as day 15, with continued improvement through day 57.*

“We know that the symptoms of dry eye disease, which include eye dryness, blurred vision, burning, stinging and eye pain, can have a significant impact on daily activities such as reading, driving, working on a computer and using devices,” said Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb. “These study results build on an impressive data set showing MIEBO as a well-tolerated and effective treatment option for dry eye disease that also can deliver much-needed, fast-acting symptom relief. In particular, the study answers the question of how quickly patients can experience relief prior to day 15, which was the first evaluation point in the phase 3 studies.”

The prospective, multicenter, open-label phase 4 study evaluated the effect of MIEBO on symptom severity and frequency early in treatment.* Inclusion criteria aligned with the phase 3 studies where all patients had a history of dry eye disease and evidence of meibomian gland dysfunction. Patients completed early outcome surveys during four clinic visits (day 1 [pretreatment; 5 and 60 minutes post-first administration] and days 3, 7, and 14). Patients rated symptom severity, symptom frequency and treatment satisfaction on a visual analog scale (VAS) from 0 to 100.

“Rapid relief of dry eye symptoms is an important factor for adherence to treatment,” said Shane R. Kannarr, OD, study author and optometrist at Kannarr Eye Care in Kansas. “These patient-reported results show that MIEBO provided relief from dry eye symptoms quickly – in some cases in as little as five minutes after the patient’s first use – and that relief was maintained and improved over the two-week period. The study also demonstrated high patient treatment satisfaction, another important element for patient compliance, and patients described the product as silky, smooth and soothing.”

Key points from the trial (for all results P<0.0001):

  • Patients reported that MIEBO significantly reduced overall symptom severity at the primary endpoint of day 7.
    • The primary endpoint of change from baseline in the severity of overall dry eye symptoms at day 7 was met. Mean overall symptom severity decreased significantly from 72.1 (17.0) at baseline to 27.8 (22.3) at day 7 (mean change, − 44.5).
  • Significant symptom relief was observed within 5 and 60 minutes after a single administration on day 1:
    • The mean score on the VAS for overall dry eye symptoms was 72.1 (17.0) at baseline and decreased to 38.5 (22.8) at 5 min post-administration and 31.7 (22.1) at 60 min post-administration.
  • Significant reductions were seen for overall symptom severity and across all symptoms, including dryness, blurred vision, eye irritation, light sensitivity, eye tiredness, burning/stinging, itching and eye pain, at all post-baseline assessments.
  • Significant decreases were also observed in mean frequency of awareness of dry eye symptoms, fluctuations in quality of vision and time experiencing the most bothersome symptoms:
 Mean Frequency of Awareness of Dry Eye SymptomsFluctuations in Quality of VisionMean % of Time Experiencing Most Bothersome Symptoms
Baseline77.6%62.8%77.9%
Day 339.7%29.8%46.7%
Day 732.6%24.5%41.3%
Day 1427.6%19.4%34.7%
  • Median satisfaction ratings increased steadily from 83.0 at day 3, 86.0 at day 7, and 90.0 at day 14, reflecting high patient satisfaction with MIEBO.
  • From 10 descriptors, study participants most commonly chose “silky, smooth and soothing” to describe how the drop felt on administration.
  • MIEBO was well tolerated with no reports of treatment-related adverse events.

For more information about MIEBO, please visit www.miebo.com.

*About MIEBO Pivotal and Early Efficacy Studies

GOBI and MOJAVE were two pivotal 57-day, multicenter, double-masked, saline-controlled studies conducted in adults ≥18 years old with a self-reported history of DED in both eyes and clinical signs of meibomian gland dysfunction. Patients administered one drop of MIEBO four times daily during the study. Primary endpoints were change from baseline in total corneal staining and change from baseline in eye dryness score (Visual Analog Scale [VAS]) at Day 57. Day 15 was the earliest time point at which signs and symptoms were evaluated in the trials. Day 57 (primary endpoints) was the last.

Individual symptom data for GOBI: Mean (SD) CFB –27.4 (27.9) for MIEBO (n = 289) vs –19.7 (26.7) for control (n = 279) (P<0.001) at Day 57. Individual symptom data for MOJAVE: Mean (SD) CFB –29.5 (28.6) for MIEBO (n = 302) vs –19.0 (27.2) for control (n = 296) (P<0.001) at Day 57.

The Early Efficacy study was a prospective, multicenter, open-label phase 4 study in adults ≥18 years old (N=99) with a self-reported history of DED in both eyes and clinical signs of meibomian gland dysfunction. Patients administered one drop of MIEBO four times daily in both eyes for 14 days. The primary endpoint was change from baseline in the severity of overall dry eye symptoms at day 7 (Visual Analog Scale [VAS]). Study limitations include the open-label design, absence of a control group, lack of assessment of clinical signs of DED, and limited diversity of the study population.

Disclaimer: Data should be interpreted with caution. No formal conclusions should be drawn.

INDICATION
MIEBO® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease.

IMPORTANT SAFETY INFORMATION

  • MIEBO should not be administered while wearing contact lenses. Contact lenses should be removed before use and for at least 30 minutes after administration of MIEBO
  • Instruct patients to instill one drop of MIEBO into each eye four times daily
  • The safety and efficacy in pediatric patients below the age of 18 have not been established
  • The most common ocular adverse reaction was blurred vision (1% to 3% of patients reported blurred vision and conjunctival redness)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information for MIEBO.

References

  1. Dana R, Bradley JL, et al. Estimated prevalence and incidence of dry eye disease on coding analysis of a large, all-age United States health care system. Am J Ophthalmol. 2019;202:47-54. doi:10.1016/j.ajo.2019.01.026.
  2. Dana R, Meunier J, Markowitz Jt, Joseph C, Siffel C. Patient-reported burden of Dry Eye disease in the United States: Results of an online cross-sectional survey. Am J Ophthalmol. 2020;216,7-17. doi:10.1016/j.ajo.2020.03.044.
  3. Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Cohort: a retrospective study. Cornea, 31(5), 472-478. 2012;31(5):472-478. doi:10.109/ICO.0b013e318225415a.

© 2025 Bausch + Lomb.

Click HERE for the press release.

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