Alcon to Launch TOTAL30 as the First-and-Only Monthly Replacement, Water Gradient Contact Lens

  • TOTAL30 delivers the only Water Gradient, reusable lens that is clinically shown to feel like nothing, even on day 301
  • The first breakthrough innovation in the $4 billion reusable lens segment in years2
  • Commercially available in the U.S. beginning in September 2021 and Europe later this year

GENEVA–(BUSINESS WIRE)– Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced plans to launch TOTAL30®, the first-and-only monthly replacement, Water Gradient lens that feels like nothing, even on day 30.1 Using Alcon’s proprietary Water Gradient material first introduced with DAILIES TOTAL1® contact lenses, TOTAL30 delivers a premium wearing experience for reusable contact lens wearers. Reusable lenses account for an estimated 45% of the $9 billion global contact lens market.2

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210810006016/en/(Photo: Business Wire)

(Photo: Business Wire)

“We are incredibly proud to expand our TOTAL® brand with TOTAL30, the newest member of the Water Gradient family, designed for reusable lens wearers,” said Andy Pawson, President and General Manager of the Global Vision Care Franchise at Alcon. “While daily disposable contact lenses remain appealing to many lens wearers, approximately two-thirds of contact lens wearers globally choose reusable lenses.3 Despite this preference, innovation within the reusable lens segment has lagged behind daily disposables over the past 10 years. Today, we change that by delivering a reusable lens with a Water Gradient surface that remains durable for a full 30 days to help people see brilliantly.” 4, 5

TOTAL30 lenses are clinically shown to feel like nothing, even on day 30,giving contact lens wearers an ultimate wearing experience in a reusable lens.1 Studies show that comfort plays a critical role in the lens-wearing experience and brand loyalty of contact lens wearers.6 Alcon capitalized on its proprietary Water Gradient contact lens material to provide a reusable lens that approaches 100% water at the surface, so all that touches the eye is a gentle cushion of moisture.7, 8* Considering many new wearers start their contact lens journey in a reusable lens, TOTAL30 provides patients with their first introduction to the exceptional comfort of Water Gradient material.

“In my experience, some reusable contact lens wearers think discomfort is the norm with lenses and attribute this to the 30-day wear cycle,”said Pamela Lowe, O.D., Professional Eye Care Center, Illinois.** “With TOTAL30, I now have a go-to lens for my patients who prefer reusable lenses and a premium wearing experience all month long. There is no longer a comfort compromise!”

The reusable, Water Gradient design of TOTAL30 is made possible by the introduction of new biomimetic CELLIGENT™ Technology. CELLIGENT combines a biomimetic surface and a unique lens chemistry to help resist bacteria and lipid deposits. 9-12 The lens features an inherently lubricious surface that is as soft as the human cornea.The Water Gradient surface of TOTAL30 is durable and remains intact during a full month of wear with daily cleaning, disinfecting and storing.4,5 The lens is compatible with all lens care solutions.

TOTAL30 sphere will be commercially available in the U.S. beginning in September 2021. In Europe, TOTAL30 will be rolled out to a limited number of countries in 2021, with full commercial availability in early 2022.

Please see product instructions for full wear, care and safety information.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.

Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 23,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.

*Based on in vitro measurements of unworn lenses.

**Dr. Lowe is a paid Alcon consultant.

References

  1. In a clinical study wherein patients (n=66) used CLEAR CARE® solution for nightly cleaning, disinfecting, and storing; Alcon data on file, 2021.
  2. Internal Estimates.
  3. Internal Estimates.
  4. Surface property analysis of lehfilcon A lenses out of pack and after 30 days of wear; Alcon data on file, 2020.
  5. Surface observations of lehfilcon A contact lens and human cornea using scanning transmissions electron microscopy; Alcon data on file, 2020.
  6. Schnider C. Evaluating Monthly Replacement CL Patient Satisfaction. Abstract and lecture presented at the American Academy of Optometry Conference 2016, Orlando, FL.
  7. In vitro analysis of lehfilcon A contact lenses outermost surface softness and correlation with water content; Alcon data on file, 2021.
  8. In vitro analysis of lens oxygen permeability, water content, and surface imaging; Alcon data on file, 2021.
  9. Ishihara K, Fukazawa K, Sharma V, Liang S, et al. Antifouling silicone hydrogel contact lenses with a bioinspired 2-methacryloyloxyethyl phosphorylcholine polymer surface. ACS Omega. 2021;6:7058-7067.
  10. In vitro evaluation of bacterial adherence in commercial lenses: Alcon data on file, 2020.
  11. In vitro evaluation of bacterial biofilm in commercial lenses: Alcon data on file, 2020.
  12. In vitro evaluation of lipid deposition for lehfilcon A and commercial lenses using 3D confocal imaging; Alcon data on file, 2021.

Continued Increase of Axial Length and Its Risk Factors in Adults With High Myopia

Abstract

Importance: Pathologic myopia due to an excessive increase of axial length is associated with severe visual impairments. Systematic analyses to determine the rate of and the risk factors associated with the axial elongation in adults with high myopia based on long-term follow-up of a large population are needed.

Objective: To determine the risk factors associated with axial elongation in adults with high myopia.

Design, setting, and participants: This cohort study used the medical records of 43 201 patient visits in a single-hospital database that were collected from January 3, 2011, to December 28, 2018. A total of 15 745 medical records with the patients’ sex, best-corrected visual acuity (BCVA), axial length, type of myopic maculopathy, and the presence or absence of choroidal neovascularization (CNV) were reviewed. Data were analyzed from April 3, 2019, to August 5, 2020.

Main outcomes and measures: Changes in the axial length at each examination were calculated. The significance of the associations between the annual increase of the axial length and age, sex, baseline axial length, types of myopic maculopathy, and a history of CNV was determined. Generalized linear mixed models were used to evaluate the strength of the risk factors associated with an increase of the axial length in high myopia.

Results: Among 1877 patients with 9161 visits included in the analysis, the mean (SD) age was 62.10 (12.92) years, and 1357 (72.30%) were women. The mean (SD) axial length was 29.66 (2.20) mm with a mean (SD) growth rate of 0.05 (0.24) mm/y. Among the 9161 visits, 7096 eyes (77.46%) had myopic maculopathy and 2477 eyes (27.04%) had CNV. The odds ratio for inducing a severe elongation of the axial length was 1.46 (95% CI, 1.38-1.55) for female sex, 0.44 (95% CI, 0.35-0.56) to 0.63 (95% CI, 13 0.50-0.78) for older than 40 years, 1.33 (95% CI, 1.15-1.54) for BCVA of less than 20/400, 1.67 (95% CI, 1.54-1.81) to 2.67 (95% CI, 2.46-2.88) for baseline axial length of 28.15 mm or greater, 1.06 (95% CI, 0.96-1.17) to 1.39 (95% CI, 1.24-1.55) for the presence of maculopathy, and 1.37 (95% CI, 1.29-1.47) for prior CNV.

Conclusions and relevance: This cohort study found continuing axial elongation in adults with high myopia. The risk factors for elongation do not appear to be modifiable, so prevention of myopia may be the best approach to reduce the incidence of pathologic myopia and its complications in the future.

Du R, Xie S, Igarashi-Yokoi T, Watanabe T, Uramoto K, Takahashi H, Nakao N, Yoshida T, Fang Y, Ohno-Matsui K. Continued Increase of Axial Length and Its Risk Factors in Adults With High Myopia. JAMA Ophthalmol. 2021 Aug 26. doi: 10.1001/jamaophthalmol.2021.3303. Epub ahead of print. PMID: 34436537.

https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2783396

Prevalence Trend of Myopia after Promoting Eyecare in Preschoolers: A Serial Survey in Taiwan Before and During the COVID-19 Pandemic

Abstract

Purpose: To report the prevalence of preschool myopia after implementing a policy intervention promoting outdoor activities and its secular trend before and during the coronavirus disease 2019 (COVID-19) pandemic in a Taiwan preschool population.

Design: Repeated countywide population-based, cross-sectional surveys based on the Yilan Myopia Prevention and Vision Improvement Program (YMVIP).

Participants: Among 23,930 kindergarteners aged 5-6 years from seven school-year cohorts in Yilan County from 2014 through 2020, a total of 21,761 (90.9%) were finally included for analysis.

Methods: Since launching the YMVIP in August 2014, myopia prevention strategies, such as increasing outdoor activities (2 hours/weekday), have been promoted in all kindergartens, and countywide school-based eye examinations, including cycloplegic autorefraction, and caregiver-administered questionnaires have been performed annually for all participants.

Main outcome measures: The prevalence of myopia (spherical equivalent [SE] ≤-0.5D in either eye) in each of the seven school-year cohorts of preschoolers aged 5-6 years RESULTS: The prevalence of myopia continuously decreased for 2 years after implementing the YMVIP (2014 cohort: 15.5% [95% confidence interval (CI), 14.2%-16.8%]; 2015 cohort: 13.5% [95% CI, 12.3%-14.7%]; 2016 cohort: 8.4% [95% CI, 7.4%-9.4%]). Since then, the subsequent cohorts had been maximally exposed to these school-based myopia prevention strategies, and the prevalence of myopia remained relatively stable between 8.5% and 10.3%, even during the COVID-19 pandemic. Multivariable logistic regression analysis showed a dose-dependent association between the duration of exposure to preventive strategies and the prevalence of myopia (up to one-year YMVIP exposure: odds ratio [OR], 0.86; 95% CI, 0.74-0.99; up to two-year YMVIP exposure: OR, 0.56; 95% CI, 0.50-0.63) after controlling other myopiogenic factors.

Conclusions: This population-based evidence showed high prevalence of preschool myopia and an L-shaped decline after introducing strategies to promote outdoor activities in kindergartens. With undisrupted school-based preventive strategies, the prevalence of myopia can be kept stable even during the COVID-19 pandemic.

Yang YC, Hsu NW, Wang CY, Shyong MP, Tsai DC. Prevalence Trend of Myopia after Promoting Eyecare in Preschoolers: A Serial Survey in Taiwan Before and During the COVID-19 Pandemic. Ophthalmology. 2021 Aug 20:S0161-6420(21)00610-2. doi: 10.1016/j.ophtha.2021.08.013. Epub ahead of print. PMID: 34425129.

https://www.aaojournal.org/article/S0161-6420(21)00610-2/fulltext

Analysis of treatment response about low-dose (0.01%) atropine eye-drops in myopic children

Abstract

Introduction: Myopia usually commences during primary school and progresses until the mean age of 16 years. Topical low-dose (0.01%) atropine eye-drop appears to be safe and efficacious for myopia control in children. However, in some cases, a higher concentration of atropine is required in some cases because low-dose atropine treatment is not effective.

Methods: This is a retrospective study among young myopic children between 5 and 15 years with myopia progression > 0.50 D/year. We selected patients treated with low-dose atropine (0.01%) eye-drops for 12 months and conducted a comparative analysis of the group with good responder and poor responder. Patients were classified as good responders if spherical equivalent refractive error (SE) progression was ⩽ 0.50 D after 12 months of treatment and poor responders if SE progression > 0.50 D. The prognostic factors before and after treatment were analyzed in two groups.

Results: A total of 68 eyes were included. Low-dose (0.01%) atropine eye-drops have a good treatment response in 54% of patients. In the good responder group (n = 37), the mean rate of myopia progression after 12 months of treatment (0.36 ± 0.17 D) was significantly slower compared with the baseline progression (p < 0.001). Good responders have smaller changes in axial length (AL) elongation and SE than poor responders (p < 0.001). The only adverse event was temporary near vision difficulty (10%), photophobia (10%), and mild pupil dilation (30%).

Discussion: The AL elongation is an important indicator for monitoring the treatment response. Children with a family history of myopia at a young age may not respond well to low-dose (0.01%) atropine eye-drops. In these cases, increasing the concentration of atropine eye-drops should be considered.

Jeon GS, Hong IH, Lee JH, Song TG, Lee TY, Han JR. Analysis of treatment response about low-dose (0.01%) atropine eye-drops in myopic children. Eur J Ophthalmol. 2021 Aug 16:11206721211038817. doi: 10.1177/11206721211038817. Epub ahead of print. PMID: 34399596.