It has long been debated as to whether or not contact lens wear, in and of itself, is "inflammatory" in nature—albeit, perhaps "subclinical" when not in the context of an outright complication. This week’s abstract highlights a new dimension regarding the potential importance of inflammation, in particular as it relates to contact lens dry eye and discomfort. The study demonstrates improvements in both subjective and objective biological parameters with various anti-inflammatory approaches. Hopefully, this new learning can be translated into clinical care, as appropriate, for your patients.
Jason J. Nichols, OD, MPH, PhD
Sun Pharma Announces U.S. FDA Approval of Cequa to Treat Dry Eye Disease
Sun Pharmaceutical Industries Ltd. announced that Sun Pharma has received approval for Cequa (cyclosporine ophthalmic solution) 0.09% from the U.S. Food and Drug Administration (FDA). Cequa is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients who have keratoconjunctivitis sicca (dry eye).
According to the company, Cequa provides the highest FDA-approved concentration of cyclosporine A (CsA) and incorporates a nanomicellar technology that allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer, and prevent the release of the active lipophilic molecule prior to penetration. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA, according to the company.
Cequa (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use will be commercialized in the United States by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary. The company expects Cequa to become available in November.
ABB Optical Group Appoints Thomas E. Burke III as CEO
ABB Optical announced the appointment of Thomas E. Burke III to CEO. Mr. Burke will assume CEO responsibilities from Angel Alvarez, who will remain as chairman. Brad Weinbrum will continue as president.
Prior to joining ABB Optical, Mr. Burke was CEO of Massachusetts-based Medical Specialties Distributors, a supply chain solutions provider for the home infusion therapy, home medical equipment, and oncology markets. Previously, he served as vice president/general manager of the specialty distribution division of Cardinal Health and then as senior vice president/general manager for Cardinal Health’s acute pharmaceutical distribution business and numerous solutions companies. He was CEO and president of Miami-based Novis Pharmaceuticals, a start-up national distributor of therapeutic products, which was acquired by Cardinal Health.
ABB Optical Group founder Angel Alvarez will continue to guide the strategic vision of the company as chairman, partnering closely with Mr. Burke and Mr. Weinbrum.
EyePoint Appoints John Weet as Senior Vice President, Regulatory Affairs & Quality
EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced the appointment of John Weet, PhD, as senior vice president, Regulatory Affairs & Quality. Dr. Weet brings to EyePoint more than 40 years of experience in regulatory affairs. He has extensive expertise in the oversight of U.S. Food and Drug Administration relations and negotiations across multiple therapeutic areas, including ocular disease.
Prior to joining EyePoint, Dr. Weet served as vice president, Regulatory Affairs and Quality Assurance at Collegium Pharmaceutical. Prior to Collegium, Dr. Weet was vice president, Regulatory Affairs at Durata Therapeutics (acquired by Actavis plc) and Vertex Pharmaceuticals. He also previously served as vice president, Global Regulatory Affairs at Bausch + Lomb, a wholly owned subsidiary of Bausch Health.
BHVI Launches “Guidelines for Myopia Management” Tool
Brien Holden Vision Institute (BHVI) has launched its “Guidelines for Myopia Management,” an easy-to-use, practical tool developed to assist busy eyecare professionals in managing patients who have myopia. Available for free online, the guidelines provide a framework to inform diagnostic tests, risk assessment, and appropriate myopia management options and to schedule follow-up visits and tests.
Free paper and poster abstract submissions may include new and innovative concepts on all aspects of contact lenses (such as materials, designs, lens care) in addition to related topics such as corneal and ocular surface disease, diagnosis and treatment approaches, and practice management.
Abstract submissions for free papers and posters will be accepted until Aug. 31, 2018 at 11:59 pm Eastern Standard Time (EST) and must be submitted online.
What influence does a rebate have on the selection and prescribing of a contact lens?
Toricity of the sclera is quite common, so it is not surprising that scleral lenses that have spherical haptics will not be aligned in all meridians. After dabbing fluorescein on the superior bulbar conjunctiva, a trickle can be seen to seep under the lens. Many practitioners feel that some tear exchange is beneficial as long as it is not excessive, which could lead to midday fogging.
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CARE SOLUTION CORNER
Andrew D. Pucker, OD, PhD
Don’t Forget Backup Glasses!
As a reader of this column, you are likely a contact lens enthusiast trying to take in as much contact lens-related information as possible. Spectacles may not be your focus and are not talked about all that frequently in Contact Lenses Today. However, spectacles are often referred to as backup glasses for contact lens wearers.
Have contact lens patients ever pulled out a several-years-old pair of discolored glasses that were multiple diopters worth of power away from their best manifest refraction? While eyecare practitioners may provide all of their patients with a new spectacles prescription at each comprehensive exam, it is likely that some of our contact lens patients are not filling their prescriptions.1 One study by Glavas et al specifically found that 59.6%, 27.7%, and 4.3% of contact lens wearers owned one, two, and three pairs of glasses, respectively.1 However, based upon my clinical experience, I bet that many of these subjects owned outdated glasses. I have also found that it is not uncommon for contact lens wearers to be without a pair of glasses.
The Centers for Disease Control and Prevention recommends that all contact lens wearers own a pair of backup glasses because patients may encounter situations in which contact lens use is contradicted.2 Contradicted situations may be planned, such as a trip abroad where the lack of clean water or climate may make contact lens use prohibitive, or they may be unplanned, such as an ocular microbial infection.2-4 Either way, clinicians need to be asking their patients whether they have functional backup glasses, and they need to be educating those patients as to why it is important to own a pair of good backup glasses so that they can be prepared for every potential situation.
1. Glavas IP, Patel S, Donsoff I, Stenson S. Sunglasses- and photochromic lens-wearing patterns in spectacle and/or contact lens-wearing individuals. Eye Contact Lens. 2004 Apr;30:81-84.
2. Centers for Disease Control and Prevention. Protect Your Eyes. 2015 Dec 11. Available at https://www.cdc.gov/contactlenses/protect-your-eyes.html. Accessed on Aug. 8, 2018.
3. Leggat PA, Speare R, Moon ME. Sore eyes and travelers. J Travel Med. 1999 Mar;6:45-47.
4. Bauer IL. Contact lens wearers' experiences while trekking in the Khumbu region/Nepal: a cross-sectional survey. Travel Med Infect Dis. 2015 Mar-Apr;13:178-184.
MATERIALS & DESIGNS
David L. Kading, OD
The Nearsighted Nurse
I have had a longtime patient, Nancy the nurse, who has been a happy contact lens wearer. Recently, she became presbyopic and is ready to try something new. She works at our local hospital in the Labor and Delivery department. She has been wearing her distance contact lenses, but now realizes that they are becoming harder for her to wear because she has a hard time seeing up close to take measurements and to chart, especially during delivery, which can be a messy time.
She told me that her nursing friends have suggested that she wear reading glasses over her contact lenses. She tried that, but she found that putting the glasses on and taking them off didn’t work so well while she was deep in the delivery process. She asked whether she should just use progressive glasses while working and then wear contact lenses while she wasn’t on shift. Uh, no. We can help you.
Nancy is a low mope who has had phenomenal distance vision and enjoys her monthly replacement lenses. She complains of mild dryness at the beginning of the day while doing scheduled early morning C-section deliveries. She doesn’t report the same amount of dryness at the end of the day.
Noting some diffuse corneal staining at her morning appointment, she was diagnosed with solution sensitivity. My go-to multifocal lens is a daily disposable that solves the solution problem and gets Nancy into a healthy daily disposable modality. Managing Nancy with a low-add multifocal with slight over-minus for distance has maintained her optimal distance vision with improvement for her near visual tasks. She has reported that she wears her pod-mate’s low-powered readers over her contact lenses when she is sitting charting for long periods of time, but she functions very well in the operating room and during clinic without any visual aids.
Nancy is like many of our patients. They may have that occasional solution sensitivity that can easily be solved with a peroxide solution or, better yet, a daily disposable lens. Improving vision for moderate-range tasks is simple with multifocal lenses, but as always, modulating expectations is critical for success.
Modulating Contact Lens Discomfort With Anti-Inflammatory Approaches: A Randomized Controlled Trial
The purpose of this study was to assess the efficacy of anti-inflammatory approaches, comprising a topical corticosteroid and omega-3 supplements, for modulating the inflammatory overlay associated with contact lens discomfort (CLD).
This randomized controlled trial involved 72 adults who had CLD, randomized (1:1:1:1) to one of the following: placebo (oral olive oil), oral fish oil (900 mg/d eicosapentaenoic acid [EPA] and 600 mg/d docosohexaenoic acid [DHA]), oral combined fish and flaxseed oils (900 mg/d EPA, 600 mg/d DHA, and 900 mg/d alpha-linolenic acid), or omega-3 eye-drops (0.025% EPA and 0.0025% DHA four times per day [q.i.d.]) for 12 weeks, with visits at baseline, week four, and week 12. At week 12, participants who received placebo were assigned a low-potency corticosteroid (fluorometholone [FML] 0.1%, drop, three times per day [t.i.d.]) for two weeks (week 14).
Sixty-five participants completed the primary endpoint. At week 12, contact lens dry eye questionnaire (CLDEQ-8) score was reduced from baseline with oral fish oil (7.3 ± 0.8 units, n = 17, P < 0.05) compared to placebo (–3.5 ± 0.9 units, n = 16). FML produced significant reductions in tear IL-17A (–71.1 ± 14.3%, n = 12) and IL-6 (–47.6 ± 17.5%, n = 12, P < 0.05) relative to its baseline (week 12). At week 12, tear IL-17A levels were reduced from baseline in the oral fish oil (–63.2 ± 12.8%, n = 12, P < 0.05) and topical omega-3 (–76.2 ± 10.8%, n = 10, P < 0.05) groups compared to placebo (–3.8 ± 12.7%, n = 12). Tear IL-6 was reduced with all omega-3 interventions relative to placebo (P < 0.05) at week 12.
The authors concluded that CLD was attenuated by oral long-chain omega-3 supplementation for 12 weeks. Acute (two-week) topical corticosteroids and longer-term (12-week) omega-3 supplementation reduced tear levels of the proinflammatory cytokines IL-17A and IL-6, demonstrating parallels in modulating ocular inflammation with these approaches.
Downie LE, Gad A, Wong CY, Gray JHV, Zeng W, Jackson DC, Vingrys AJ. Modulating Contact Lens Discomfort With Anti-Inflammatory Approaches: A Randomized Controlled Trial. Invest Ophthalmol Vis Sci. 2018 Jul 2;59:3755-3766.