Optometric Physician

A weekly e-journal by Art Epstein, OD, FAAO


Volume 20, Number 51

Monday, December 7, 2020


Inside this issue: (click heading to view article)
######### Off the Cuff: FDA + FTC Does Not = Contact Lens Safety

######### Indications for Wear, Visual Outcomes and Complications of Custom Imprint 3D Scanned Scleral Contact Lens Use
######### Comparative Evaluation of Latanoprostene Bunod, Timolol Maleate and Latanoprost Ophthalmic Solutions to Assess Their Safety and Efficacy in Lowering IOP for the Management of Open-angle Glaucoma
  Visual Outcomes of Proton Beam Therapy for Choroidal Melanoma at a Single Institute in The Republic of Korea
######### News & Notes

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Off the Cuff: FDA + FTC Does Not = Contact Lens Safety

Because of their inherent risk, the US FDA has classified contact lenses as Class II or Class III medical devices since 1976. While lenses have certainly gotten safer over the years, clinicians know that serious contact lens complications can be devastating. That’s one reason why federal law wisely restricts contact lens sales to be either by or on the order of a licensed practitioner. However, despite the well-recognized risks and the FDA’s own regulations, the agency has largely ignored the clinical reality as well as their responsibility to the public by failing to enforce their own regulations.

The FDA’s turning a blind eye to contact lens regulation started years back when companies like 1-800 openly flouted both federal and state laws by dispensing contact lenses either without valid prescriptions or contrary to existing state practice laws. I was told back then that the FDA did consider cracking down on illegal lens sales and was about to, but political pressure from Utah forced them to sit on their hands. This allowed online sellers time to convert credible patient safety concerns into a PR-driven faux consumer rights campaign. Ultimately, the FTC got involved.

When I addressed the FTC earlier this year, I explained that the existing contact lens rule had been successful, and that the cost of lenses dispensed from brick-and-mortar optometry and ophthalmology practices were actually lower than online prices. They didn’t seem to care. I reminded them that the overwhelming majority of ODs and MDs were compliant with the existing law, and that further regulation was unwarranted and unnecessary. One of them, an attorney with a PhD, no less, shared that because his OD didn’t give him his lens prescription, he felt it was likely that all ODs were ignoring the law. I stared in disbelief. I told them that the tactics used by many of the online lens sellers gamed the passive verification system, which put patients at risk. They weren’t moved.

I still ponder the motivation for “fixing” a non-existent problem while ignoring serious existing ones. Regardless, while the updated FTC Contact Lens rule is asinine and accomplishes nothing other than wasting time and resources, it is the law. However, there are still things that we can do to reverse this regulatory overreach. Thanks to the AOA, the Contact Lens Rule Modernization Act is advancing in the US Senate. The bill addresses the flaws and burdens of the new FTC rule while targeting patient safety issues by banning automated prescription verification robocalls.

It is important that you contact your senators and request that they cosponsor or at least support this bill. S.4613. You can find more information on the AOA Action Center . Beyond that, perhaps it is time that the AOA, the AAO, the Academy of Ophthalmology and ASCRS initiate dialog to explore ways of assisting the FDA to regain regulatory control of contact lenses. In the end, this is and always has been a public health issue—one that we can and should work together on.


Arthur B. Epstein, OD, FAAO
Chief Medical Editor


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Medical Information LLC (JMI), or any other entities or individuals.



Indications for Wear, Visual Outcomes and Complications of Custom Imprint 3D Scanned Scleral Contact Lens Use

A retrospective review identified all patients fitted with the EyePrintPRO (EPP) scleral contact lens (SCL) between December 2013 and March 2018, to report indications for wear, visual outcomes and complications of use. Baseline demographics, wear indication and contact lens history were determined. Habitual-corrected visual acuity was measured at baseline and follow-up. Adverse wear symptoms and signs, reprinting and device cessation were tracked.

Ninety-five eyes from 69 patients were followed for a median of 12.1 months (interquartile range 4.4 to 19.6). Indications for wear included vision improvement and/or ocular surface stabilization in the setting of irregular corneal shape (n=68 eyes, 72%), ocular surface disease (n=17, 18%), exposure keratopathy (n=7, 7%), neurotrophic keratitis (n=5, 5%) and extracorneal topographical abnormalities preventing non-custom lens fitting such as glaucoma drainage devices (n=8, 8%). Median habitual-corrected visual acuity improved from 0.67 to 0.08. One-third of eyes (33.1%) developed adverse wear symptoms. Fifteen of 95 eyes (16%) developed adverse wear signs. Device cessation occurred in 10 eyes (10.5%), and reprinting occurred in 14 eyes (14.7%) unrelated to prior lens wear or indication. In eyes that previously failed SCLs (n=56), 12 eyes required reprinting, and 49 eyes continued use.

Researchers wrote that indications for EPP wear include irregular corneal shape, ocular surface disease and extracorneal topographic abnormalities. They added that visual acuity improves with the use of EPP. Furthermore, researchers advised, clinicians and patients should be aware of potential adverse wear symptoms/signs and device cessation that may occur with EPP use. EPP is a viable salvage therapy in eyes that previously failed SCLs.

SOURCE: Silverman JIM, Huffman JM, Zimmerman MB, et al. Indications for Wear, Visual Outcomes, and Complications of Custom Imprint 3D Scanned Scleral Contact Lens Use. Cornea. 2020 Nov 25. [Epub ahead of print].


Comparative Evaluation of Latanoprostene Bunod, Timolol Maleate and Latanoprost Ophthalmic Solutions to Assess Their Safety and Efficacy in Lowering IOP for the Management of Open-angle Glaucoma

Timolol maleate has been reported to be a safer intraocular pressure (IOP) lowering treatment than latanoprost. The US FDA approved latanoprostene bunod, a nitric oxide-donating prodrug of latanoprost, for lowering IOP. This study compared the safety and efficacy of latanoprost, latanoprostene bunod and timolol maleate in patients with open-angle glaucoma. Patients who received latanoprost eye drops once daily in the evening were included in the latanoprost ophthalmic solutions (LP) cohort (n=104). Those who received latanoprostene bunod eye drops once daily in the evening were included in the latanoprostene bunod (LB) cohort (n=94). Those who received timolol eye drops twice daily were included in the timolol maleate (TM) cohort (n=115). All treatments were administered to the affected eye(s) for three months. Informed consent was taken from each participant before the trial.

At the end of three months of treatment, latanoprost, latanoprostene bunod and timolol were all successful in reducing IOP. The LB cohort had the highest reduction in IOP, compared with the LP and TM cohorts. All treatments had some common adverse ocular effects.

Investigators wrote that latanoprostene bunod was superior to latanoprost and timolol for the treatment of open-angle glaucoma.

SOURCE: Wang Y, Liao Y, Nie X. Comparative evaluation of Latanoprostene Bunod, Timolol Maleate, and latanoprost Ophthalmic Solutions to assess their safety and efficacy in lowering intraocular pressure for the management of Open-Angle Glaucoma. Clinics (Sao Paulo). 2020 Nov 30;75:e1874.




Visual Outcomes of Proton Beam Therapy for Choroidal Melanoma at a Single Institute in The Republic of Korea

Researchers evaluated the ocular effects of proton beam therapy (PBT) at a single institution in Korea, and identified factors contributing to decreasing visual acuity (VA) after PBT. A total of 40 patients who received PBT for choroidal melanoma (2009 to 2016) were reviewed. Dose fractionation was 60 to 70 cobalt gray equivalents (CGEs) over five fractions. Complete ophthalmic examinations including funduscopy and ultrasonography were performed at baseline and at three, six and 12 months after PBT, then annually thereafter. Only patients with at least 12 months follow-up were included. During the follow-up, consecutive best-corrected visual acuity (BCVA) changes were determined, and univariate and multivariate logistic regression analyses were performed to identify predictors for VA loss.

The median follow-up duration was 32 months (range: 12 to 82 months). The final BCVA of nine patients was >20/40. The main cause of vision loss was intraocular bleeding, such as neovascular glaucoma or retinal hemorrhage. Vision loss was correlated with the tumor size, tumor distance to the optic disc or fovea, maculae receiving 30 CGEs, optic discs receiving 30 CGEs and retinas receiving 30 CGEs. Approximately one-third of PBT-treated choroidal melanoma patients with good pretreatment BCVA maintained their VA. The patients who finally lost vision (VA
Researchers found that tumor size, tumor distance to the optic disc or fovea, volume of the macula, and optic discs or retinas receiving 30 CGEs affected the final VA.

SOURCE: Jung SK, Park YH, Shin DH, et al. Visual outcomes of proton beam therapy for choroidal melanoma at a single institute in the Republic of Korea. PLoS One. 2020 Dec 2;15(12):e0242966.


News & Notes

Bausch Health Initiates Second Phase III Study for NOV03
Bausch Health Companies and Bausch + Lomb initiated the second of two Phase III studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction. NOV03 is an investigational, proprietary, water-free and preservative-free solution based on patented EyeSol technology from Novaliq GmbH. Read more.


  Oculus Welcomes Tullo
Oculus announce that William Tullo, OD, FAAO, joined its team as a medical director in November. In this newly developed role, Dr. Tullo will provide clinical guidance and educate medical eye professionals on Oculus diagnostic devices. He will also work closely with the leadership team to align goals and strategies with the mission and vision of the organization.

Topcon Announces the US Launch of RDx
Topcon Healthcare launched its new Topcon RDx ocular telehealth software platform to the US market. The platform enables practitioners to connect to their offices remotely and conduct comprehensive eye exams in real-time from virtually anywhere. RDx connects to Topcon's CV-5000S digital phoropter, for fully remote refractions. Read more.

  Registration Open for ISVA Virtual Conference
Registration is now open for Joining Forces to Enhance Athletic Performance, the 5th Annual International Sports Vision Association conference to be held virtually February 20 to 21, 2021. All presentations will be available on-demand through April 10, 2021. This year’s program will offer up to 14 COPE-approved CE credits and include a diverse offering of educational sessions. Learn more.

  Eyenovia Announces FDA Acceptance of IND for MicroLine
Eyenovia announced the FDA accepted its Investigational New Drug application for MicroLine, a proprietary pilocarpine formulation for the improvement in near vision in patients with presbyopia. The company intends to initiate the Phase III VISION program, beginning with the VISION-1 study later this month. Read more.

  Prevent Blindness Declares December Give the Gift of Sight Month
Prevent Blindness has declared December Give the Gift of Sight Month, and is asking the public to reflect on the joys of healthy vision by donating to Prevent Blindness. Since 1908, Prevent Blindness has worked to provide services and programs to protect vision in the United States. Donate here.

Federal Court Enters Preliminary Injunction Against Myco and Choate
BlephEx announced a victory in its patent infringement lawsuit against Myco and John Choate concerning the AB Max device. Recently, the United States District Court for the Eastern District of Michigan granted BlephEx’s motion for a preliminary injunction against Myco and Choate. The court entered a preliminary injunction prohibiting both from “selling, distributing, offering to sell or distributing to customers in the United States” the ABMax and/or its swabs until a final judgment is entered in the suit.







Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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