New Data from VTI’s PROTECT Clinical Trial for Myopia Progression Control Presented at ARVO

Visioneering Technologies, Inc, producer of the NaturalVue^® Multifocal 1 Day Contact Lenses (NVMF), continued its release of the 1-year prospective data of its ongoing multi-center, randomized, double-masked, controlled trial (RCT) at the Association for Research in Vision and Ophthalmology (ARVO). PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) was designed to demonstrate the safety and effectiveness of NVMF for myopia progression control in children. PROTECT is a 3-year study involving 145 children with analyses planned after the 1-year and 2-year marks.

Dr. Ashley Tuan, Chief Medical Officer for VTI, presented new data from the PROTECT trial that focused on details of axial length and wearing time. Dr. Tuan also summarized data released earlier in the year on refractive error change and reduction. The poster entitled, “A Randomized Controlled Trial for Myopia Progression Control Using Catenary Power Profile Contact Lenses: 12-month Effectiveness and Safety,” was prepared by Dr. Tuan and Dr. Sally Dillehay.

The new data that outlines the distribution of change in axial length (mm) in patients showed that 58% of patients wearing NaturalVue had axial growth similar to age-matched emmetropic children. This data point, especially when paired with the previously release distribution of change in refractive error (D) data showing that 2/3 of patients or 64% experienced no meaningful progression of myopia (defined as -0.25 D or less of progression) further suggests NaturalVue Multifocal may effectively manage myopia among children under diverse clinical settings and populations.

Compliance is believed to be essential for myopia control success and is influenced by the quality of vision and comfort.¹ Given that children on average wore NaturalVue for 11-12 hours per day is indicative that the lens provides excellent vision and comfort and a positive quality of life experience. We believe that these factors did contribute to the positive results seen thus far in the PROTECT study.

In addition to the new learnings listed above, the 1-year data set has revealed the following results thus far:

45% of patients had no progression (change <= 0 Diopters (“D”)) and ~2/3 of patients or 64% experienced no meaningful progression of myopia (defined as -0.25D or less of progression per year).
- 71% or (0.41D) reduction in refractive error progression, versus the control group.
  - Children wearing NaturalVue Multifocal Contact lenses showed an average refractive error change of 0.18 D.
0.17mm or 61% average reduction in axial elongation, versus the control group.
- The average axial length change in children wearing NaturalVue Multifocal Contact lenses was 0.11 mm.

One-year data from studies of similar design to PROTECT have been predictive of the final 3-year results.² The PROTECT study data will continue to be reviewed and analyzed with additional details to be shared as available. The final results of the study and any regulatory uses thereof will be based on the analysis of the complete 3-year data set.

“For the majority of patients, the study showed that NaturalVue held axial length growth to that of age-matched emmetropic children. Additionally, the wearing time results are important as these are directly related to the results seen across the study. These new data continue to validate our confidence in the effectiveness of NaturalVue Multifocal Contact Lenses. NaturalVue Multifocal 1 Day will continue to mine the study and share results with the industry and eye care practitioners around the world.”

Dr. Ashley Tuan, VTI Chief Medical Officer

“As we continue to glean new learnings from this extensive data set, it is evident that NaturalVue represents a powerful tool for eye care practitioners to use to manage myopia. These results should provide confidence to both eye care practitioners and parents that NaturalVue will provide excellent vision for patients while also helping to slow the progression of patients’ myopia.”

Dr. Juan Carlos Aragón, Chief Executive Officer and Executive Director of VTI

VTI expects to release longer-term 2- and 3-year data when available.

To download a Fact Sheet summarizing the findings to date, click here.

* Note: This reflects the 1-year data set. The PROTECT study is ongoing and data will be reviewed, analyzed, and shared as available. Data presented here are limited by the range of age, race, geographical locations and study duration.

Data is based on a modified PP (Per Protocol) analysis including children between ages 8 and <13 with refractive error between -0.75 and -4.00 D versus age-matched controls wearing spherical lenses. SD = standard deviation

This information may describe uses for this product, i.e., Myopia Progression Control, which have not been approved by the FDA for use in the United States. It is intended for educational purposes only. NaturalVue^® Multifocal is part of an ongoing randomized clinical trial (RCT) studying its effectiveness for myopia progression control.

Myopia control: Seeing beyond efficacy. Optom Vis Sci. 2024 Mar 1;101(3):134-142. doi: 10.1097/OPX.0000000000002119. PMID: 38546754.
Efficacy in myopia control. Progress in Retinal and Eye Research 83 (2021) 100923
VTI-RCT-PR4

Click HERE for the full press release.

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May 7, 2024March 25, 2024

New Gradient and Lighter Acetate

Voila Optik March-April 2024 GIGI STUDIOS Hilary

GIGI STUDIOS presents HILARY (6889/0), a design crafted from high-quality Italian
acetate. It is extremely lightweight due to the inner bevels and the thinner acetate
used. The gradient colour of the acetate has turned this model into one of the most
acclaimed in the GIGI STUDIOS Spring-Summer collection. A genuine declaration of
style that does not compromise on comfort.

Distributed by GIGI STUDIOS: gigistudios.com

About GIGI STUDIOS:

GIGI Studios is a brand founded in Barcelona by a family that has always been surrounded by glasses. This family spirit has led to partnerships with independent eyewear sellers and distributors in more than 45 countries. At GIGI Studios, we transmit knowledge and experience while passionately embracing the future.

Without distinction, GIGI Studios wants to support people in their self-expression by making them feel more creative and self-confident. GIGI Studios’ designs are the result of constant improvement, a process of exploration through materials, shapes, and colours seeking designs that enhance the uniqueness of the individual.

May 7, 2024May 7, 2024

Eye Health Survey Uncovers Canadians’ Concerns About Recent Symptoms Affecting Their Eyes & Vision

In time for Vision Health Month this May, the Canadian Ophthalmological Society (COS) has released a new survey to assess Canadians’ awareness, understanding, and concerns around eye and vision health.

Canadians’ Familiarity with Eye Diseases

Of the four leading eye diseases affecting vision, cataracts and glaucoma are still the most commonly known among Canadians. Two-thirds (65%) of survey respondents are familiar with cataracts – a slight increase from 62% in 2022, and more than half (53%) are familiar with glaucoma – up from 47% in 2022.

However, more education on other eye diseases is needed. Less than half (41%) are familiar with age-related macular degeneration (AMD), despite being one of the leading causes of vision loss for people over the age of 55 which affects approximately 2.5 million Canadians. Fewer (25%) are familiar with diabetic retinopathy, which can affect those living with diabetes.

“As Canadians become increasingly familiar with the four major eye diseases, there is a need for continued education to encourage proactive care. While the survey reveals increased awareness, it also highlights significant concerns and alarming symptoms experienced by Canadians over the past two years, emphasizing the necessity for comprehensive eye health education and regular eye exams.”

Dr. Phil Hooper, president, Canadian Ophthalmological Society

Eye Health Concerns and Symptoms Affecting Canadians’ Eyes and Vision

When it comes to their eye health, the majority of Canadians (81%) are concerned or have experienced at least one factor when it comes to their eyes and vision. Among the top three are too much screen time; exposure to sun/UV rays; and environmental factors, such as wildfire smoke and pollution. Canadians in BC and Alberta are directionally more concerned with environmental factors than those in the East.

In the past 2 years, 71% of Canadians have experienced one or more symptoms around their eyes or their vision, with screen time being the leading factor to their symptoms:

Dry, itchy and irritated eyes due to screen time (34%)
Headaches / eye strain due to screen time (30%)
Sensitivity to light (29%)
Blurry vision (27%)
Excessive tearing or watery eyes (26%)
Seeing halos around lights (17%)
Redness or swelling of the eyes (16%)

Advancing Eye Health Through Innovations

Regarding innovations in eye health that Canadians would like to see more of, better access to eye care (51%) and more effective treatments for eye diseases (48%) top the list, while nearly 4 in 10 (37%) would like to see less invasive treatments for eye diseases. Few Canadians want the use of Artificial Intelligence (AI) as a more efficient way to detect vision/eye problems and eye diseases (19%) and virtual eye exams (18%).

To learn more about the four major eye diseases and get information on overall eye health, visit seethepossibilities.ca.

Click HERE for the full press release.

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May 6, 2024May 6, 2024

Marcolin: Exclusive Licensing Agreement Signed with K-WAY®

Marcolin and K-Way®, French brand born in 1965 – currently owned by Turin-based group BasicNet – and known worldwide for its revolutionary rain jackets, announce they have signed an exclusive licensing agreement for the design, production, and worldwide distribution of K-Way® brand sunglasses, optical frames, ski goggles and eyewear for kids.

The partnership, officially beginning on January 1, 2025, will last 6 years, until December 31, 2030. The new agreement and resulting collaboration with a brand that has always perfectly combined a sports spirit with a fashion attitude, will allow Marcolin to further expand its license portfolio and reinforce its presence in the lifestyle segment.

The K-Way® SS25 eyewear collections – the first to be produced by Marcolin – will be presented in early 2025 to then become available worldwide by distribution through a network of selected stores.

Click HERE for the press release.

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May 2, 2024May 2, 2024

ARVO 2024: Studies Reinforce Confidence in CooperVision Myopia Management Interventions & Explore Contact Lens Comfort

CooperVision is calling attention to three studies accepted for presentation during the ARVO 2024 Annual Meeting, which is expected to attract thousands of researchers, ophthalmologists, optometrists, educators, and students to Seattle from May 5-9, 2024. As part of a broad scientific program at the conference, the company is showcasing findings related to the long-term wear of its MiSight^® 1 day contact lens, use of its Paragon CRT Dual Axis^® orthokeratology contact lens, and corneal immune cell variations in contact lens wearers that may impact comfort.

“Our presence at ARVO has grown over the past decade, reflecting our expanding commitment to eye care professionals through an evidence-based portfolio. This year’s scientific program exemplifies several aspects of our post-market and pre-commercial research alike, with the intent of expanding confidence in current products while innovating for the future.”

Francis Erard, Vice President of Research and Development, CooperVision

Long-term impact of daily disposable hydrogel soft contact lens wear on corneal endothelium in children (Lam H, Jones S, Logan N) explored the long term impact of contact lens wear on corneal endothelium and corneal morphological characteristics in children who had taken part in the MiSight^® 1 day clinical study.^* This investigator-initiated study continued to follow 20 participants—now aged in their late teens and early 20s—who successfully participated in the landmark study for 10 years at the Aston University (UK) site.

Non-contact specular biomicroscope imaging of the central corneal endothelium allowed for contiguous cell analysis across multiple parameters, including endothelial cell density, average cell area, coefficient of variation of cell area, percentage of hexagonal cells, and central corneal thickness. The researchers determined that when compared to an age-matched group of non-contact lens wearers, long term, full-time wear of their daily disposable contact lenses had no impact on the corneal endothelium.

Incidence of adverse events during 12 months of orthokeratology overnight lens wear (Voltz K, et al.) evaluated the performance of Paragon CRT Dual Axis^® (CRT-E) contact lenses^† across four sites in China, building on past clinical trials for the widely prescribed product. 177 subjects aged 8-43 years whose eyes exhibited -0.50 to -4.00 DS myopic refractive error, up to -1.50 DC of astigmatism, and no corneal abnormality, used the test lens for one year, with eight post-fitting follow-up examinations that assessed visual acuity, refraction, and lens condition.

No serious or significant ocular adverse events were reported. The low incidence of observed mild device-related ocular adverse events—all of which were resolved—affirmed the safety of Paragon CRT Dual Axis^® among myopic Chinese children and adults.

Diurnal changes in corneal dendritic cell density and morphology in symptomatic and asymptomatic contact lens wearers (Ng A, et al.) examined the variation of corneal immune cells with and without contact lens wear over a period of eight hours (from morning to evening), aiming to better understand how such dendritic immune cells can affect contact lens comfort. At least five non-overlapping sequence scans using non-invasive confocal microscopy were taken at the central and inferior cornea of 10 symptomatic and 10 asymptomatic hydrogel and silicone hydrogel habitual contact lens wearers.

Immune cells were elevated in the morning compared to the evening, irrespective of lens wear or lack thereof. Subtle differences in dendritic cell density and structure between symptomatic and asymptomatic participants suggest possible variations in ocular response to contact lens wear based on symptom status. The study also demonstrated the feasibility of corneal imaging over contact lenses, which could simplify monitoring of immune cells during lens wear.

The ARVO Annual Meeting draws approximately 10,000 vision scientists and ophthalmic professionals every year, spanning retina, cornea, glaucoma, retinal cell biology, age-related macular degeneration, diabetic retinopathy, cataracts, dry eye, basic research, and clinical private practice. For more information on the 2024 event, visit https://www.arvo.org/annual-meeting/.

^* U.S. Indications for Use: MiSight^® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal.

^† U.S. Indications for Use: Rigid Gas Permeable Paragon CRT Dual Axis^® Contact Lenses (paflufocon D) for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a Corneal Refractive Therapy fitting program for the temporary reduction of myopia up to 6.00 diopters in eyes with astigmatism up to 1.75 diopters. The lenses may be disinfected using only a chemical disinfection system.

Click HERE for the full press release.

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Blog

New Data from VTI’s PROTECT Clinical Trial for Myopia Progression Control Presented at ARVO

Eye Health Survey Uncovers Canadians’ Concerns About Recent Symptoms Affecting Their Eyes & Vision

Canadians’ Familiarity with Eye Diseases

Eye Health Concerns and Symptoms Affecting Canadians’ Eyes and Vision

Advancing Eye Health Through Innovations

Marcolin: Exclusive Licensing Agreement Signed with K-WAY®

ARVO 2024: Studies Reinforce Confidence in CooperVision Myopia Management Interventions & Explore Contact Lens Comfort

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