Transcript: Optometry Times® news summary 2/28/2021

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Allergan has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) for the treatment of presbyopia. The FDA is expected to act on the application by the end of 2021.

The application is based on data from two Phase 3 GEMINI 1 and GEMINI 2 clinical studies, which evaluated the efficacy, safety, and tolerability of the drug. A total of 750 patients were randomized in a one-to-one ratio of vehicle to AGN-190584. In both studies, AGN-190584 met the primary endpoint, reaching statistical significance in improvement in near vision in mesopic conditions without a loss of distance vision versus the vehicle. There were no serious adverse events observed. The most common non-serious adverse events in less than 5% of participants were headache and conjunctival hyperemia.

Related: Dr. Ben Casella muses on COVID-19 and vaccine

The UN Friends of Vision group, International Agency for the Prevention of Blindness, and The Lancet Global Health released new evidence showing that eye health is essential to achieving UN Sustainable Development Goals. The event also included the launch of the Agency’s Vision Atlas and the Lancet Global Health Commission on Global Eye Health.

Key messages were:

• 1.1 billion people experience vision loss primarily because they do not have access to eye care services.

• Over 90% of those with vision loss live in low- and middle-income countries, 73% of people with vision loss are over age 50, and 55% of people with vision loss are women.

• The number of people with vision loss will rise from 1.1 billion people to 1.7 billion people by 2050, mainly due to population growth and population aging.

• Over 90% of vision loss is could have been prevented.

• The leading causes of vision loss include uncorrected refractive error, unoperated cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy.

• Unaddressed poor vision results in a global economic productivity loss of $411 billion per year.

• Children with a vision impairment are up to 5 times less likely to be in formal education and often achieve poorer outcomes.

Bausch + Lomb launched in the U.S. Alaway Preservative Free (ketotifen fumarate 0.035%) antihistamine eye drops, the first over-the-counter preservative-free antihistamine eye itch relief drop approved by the FDA.

Alaway Preservative Free is prescription-strength formula that is designed to block the release of histamines and reduce allergic inflammation. Alaway provides relief within minutes and lasts up to 12 hours with one dose, according to the company.

Alaway Preservative-Free will be available for purchase at most national retailers. A 10-day supply, which is 20 single-dose vials, will have a manufacturer’s suggested retail price of $14.99.

Related: Celebrate World Glaucoma Week March 7-13, 2021

Transitions Optical unveiled Transitions XTRActive new generation lenses to provide extra darkness to wearers. The lenses are the darkest photochromic lenses in hot temperatures, the only photochromic lenses achieving category 3 levels of darkness at 35 degrees Celsius, and the only photochromic lens achieving category 2 levels of darkness in the car, according to the company. Plus, they offer 35% faster fade back.

Transitions XTRActive new generation lenses will be available in the U.S. and Canada in the third quarter of 2021 in gray, brown, graphite green, and 6 style mirrors.

Myopia management company Treehouse Eyes opens 11 new centers. The company collaborates with select primary eye care practices to deliver its proprietary myopia management system. In addition, Treehouse Eyes has launched a new website to support its growth. Find it at treehouseeyes.com.

CooperVision Specialty EyeCare launched its Paragon CRT Software for eye care professionals. The topography-guided tool includes features aimed at simplifying the fitting process for first-time CRT and CRT Dual Axis contact lens prescribers.

With a few on-screen clicks, prescribers will be able to change lens parameters, assess fluorescein patterns of different lenses on the same patient, and see simulated lens changes on a patient’s eye prior to ordering warranty exchanges. In addition, prescribers can upload patient topography maps and customize CRT and CRT Dual Axis lenses for each patient.

The software is available to download at ecp.paragonvision.com/software.

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Haag-Streit UK has launched Eyesi Slit Lamp Fundoscopy Module in the UK.

VRmagic’s new Fundoscopy Module can be mounted to the Eyesi Slit Lamp simulator table to enable a lifelike interaction. It is supported by software offering a selection of cases for retinal examination, which will be continuously extended, according to the company.

The retina cases, based on real patients, will form part of the Findings & Diagnoses course, presenting diseases affecting the optic disc, macular degeneration, and diabetic retinopathy.

The Eyesi Slit Lamp is a diagnostic training simulator for eye care practitioners. Its virtual reality technology is integrated into the original hardware of a BQ 900 slit lamp model and simulates all functions of a real slit lamp.

The World Council of Optometry or WCO will continue its official relations with the World Health Organization or WHO through 2023. The objective the collaboration is to promote the policies and strategies derived from the decisions of the governing bodies of WHO.

WCO will provide annual reports to the relevant departments within WHO, and the official relationship will be reviewed again in January 2024. WCO looks forward to continuing to work in collaboration with WHO toward its mission to promote health, keep the world safe, and serve the vulnerable.

Alcon’s Pataday Once Daily Relief Extra Strength (olopatadine 0.7%) is now available in-store and online at U.S. retailers following its 2020 approval by the FDA for sale over the counter. This is Alcon’s third Rx-to-OTC switch in the past 12 months.

Pataday Once Daily Relief Extra Strength provides 24 hours of eye allergy itch relief from pollen, ragweed, grass, animal hair, and dander with one drop, once a day, according to the company.

This launch will be supported by online, digital, and TV advertising campaigns to reach health care professionals and patients experiencing ocular allergy.

Eyevance’s Natacyn is now available next day when a doctor prescribes to specialty pharmacy NatacynRARX.When prescribed by 5 pm central, Natacyn will be shipped overnight via FedEx the next afternoon to the patient at no additional cost.

The Centre for Ocular Research & Education or CORE has published issue number 58 of its free online education magazine, Contact Lens Update. This edition launches a new case record feature that shares research-relevant yet patient-centred insights as experienced by practicing eye care professionals.

Along with other content, Dr. Andrea Lasby reviews a recent publication that investigates the potential for meibomian gland changes to distinguish dry eye from normal eyes in young adult wearers.

Plus, Dr. Andrew Pucker’s editorial addresses commonly asked questions about meibomian gland dysfunction, weighing the evidence and clinical implications for each.

Published 6 times per year, Contact Lens Update provides a global platform for unbiased clinical insights based in current research. The publication receives support from the educational arms of Alcon, CooperVision, and Johnson & Johnson Vision.

Save the date for Vision Expo East 2021. The meeting is now taking place June 2-5, 2021, at the Orange County Convention Center in Orlando, Fla.

New World Medical has launched the KDB Glide device for advanced excisional goniotomy treatment of glaucoma. KDB Glide was registered with the FDA in October 2020 and is now commercially available to ophthalmic surgeons across the U.S.

The device’s proprietary ramp facilitates lifting and stretching the trabecular meshwork, while the dual blades penetrate the trabecular meshwork and create parallel incisions for precise, controlled excision, according to the company. New features of a rounded heel, tapered sides, and smaller footplate deliver optimal interface with Schlemm’s canal, permitting precise excision, even in variable anatomy.

Kala Pharmaceuticals announced that pharmacy benefit manager Express Scripts has added Eysuvis (loteprednol etabonate) 0.25% to its National Preferred, Basic, and High Performance Formularies, effective February 5, 2021.

Eysuvis was approved in October 2020 for the short-term treatment of the signs and symptoms of dry eye disease and became commercially available in the U.S. in January 2021.

CooperVision has expanded the range of Biofinity XR toric contact lenses stocked at its global distribution center in New York. The following parameter ranges are now available to ship next day to customers:

• Sphere: Plano to -6.00 D in 0.50 D steps

• Axis: 10 degrees to 180 degrees in 10-degree steps

•Cylinder: -2.75 D and -3.25 D

Although Biofinity XR toric remains a made-to-order product for many prescriptions, the expanded inventories will speed access.

CooperVision is also stocking trial lenses in the same parameters. Orders placed directly through CooperVision and select authorized distributors will ship the following business day.

Biofinity XR toric lenses are available in sphere powers from +10.00D to -10.00D (0.50 D steps after +/-6.00D), with cylinder powers from -2.75 D to -5.75 D (0.50 steps) and axes of 5 degrees to 180 degrees in 5-degree steps.

Genentech shared new data from four Phase 3 studies of its investigational bispecific antibody, faricimab, showing it allowed a significant number of patients to go up to 4 months between treatments for 2 common causes of vision loss, diabetic macular edema and neovascular age-related macular degeneration.

According to the company, key findings from all 4 studies include:

• Approximately half of people receiving faricimab could be treated every 4 months in the first year while achieving similar vision gains compared to aflibercept given every 2 months

• Approximately 75% of people receiving faricimab in the studies could be treated every 3 months or longer in the first year

• Faricimab demonstrated rapid and consistent improvements in anatomical outcomes including central subfield thickness across all studies, and

• Faricimab was generally well tolerated, with no new or unexpected safety signals identified

Visionary Optics launches its VibrantVue product line in collaboration with ABB Optical Group.

VibrantVue Contact Lens Hand Prep is the only product marketed as a “no rinse” hand cleanser specifically for all soft and gas permeable contact lens wearers. It is available in 8-ounce and 2-ounce sizes.

VibrantVue Scleral Saline solution is the most recently FDA-approved scleral filling solution. It comes in 100 count, single-use 5-mm vials. The company is offering samples for eye care practitioners to provide to their new scleral lens patients.

VibrantVue Lid and Lash Care products include a hydrogel formulation for in-office treatment and liquid spray for at-home maintenance by patients. The 3-ounce bottles on average will last a patient 3 months.

Glaukos Corporation shares that U.S. Phase 3 pivotal trial results for its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, called Epi-on, met the study’s primary efficacy endpoint. Epi-on demonstrated a statistically significant improvement in maximum corneal curvature (Kmax) at 6 months from baseline between the treated and placebo-controlled arms.

Epi-on is designed to reduce procedure times, improve patient comfort, and shorten recovery time, according to the company. It utilizes a proprietary, novel drug formulation to penetrate the epithelial layer of the cornea, a stronger UVA irradiation protocol, and the ability to deliver increased levels of supplemental oxygen to enhance cross-linking. If approved, the company anticipates Epi-on would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the epithelium.

The Phase 3 trial results are expected to support Glaukos’ U.S. NDA submission in 2022, and the company is targeting FDA approval for Epi-on in 2023.

Now, I talk with Dr. Rob Stutman about World Glaucoma Week and then Chief Optometric Editor Dr. Ben Casellaabout coronavirus vaccines.