EyeWorld Weekly, March 4, 2022

EyeWorld Weekly, March 4, 2022

EyeWorld Weekly

March 4, 2022 • Volume 28, Number 9

FDA approves first drug-eluting contact lens

The FDA has approved ACUVUE Theravision with Ketotifen (Johnson & Johnson Vision) as the first drug-eluting, vision-correcting contact lens. According to the company’s press release, each lens contains 19 mcg of ketotifen, which is an antihistamine. This contact lens will be indicated for the prevention of ocular itch due to allergic conjunctivitis. It is a daily, disposable lens for patients who do not have red eyes and who do not have more than 1 D of astigmatism.

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FDA accepts 510(k) submission for new femto-phaco device

LENSAR announced that the FDA accepted its 510(k) submission for review of the ALLY Adaptive Cataract Treatment System, a femto-phaco device. According to the company’s press release, this submission seeks marketing clearance for the system and is the first stage of its two-step commercial release, which includes submitting an additional application for phacoemulsification features integrated in the system. If it receives FDA clearance, LENSAR expects to launch ALLY in the second half of 2022.

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Phase 2 study begins to evaluate an immunomodulatory agent for dry eye

Aramis Biosciences began a Phase 2 proof-of-concept clinical trial evaluating A197, a first-in-class, topical, immunomodulatory agent, for the treatment of dry eye disease. According to the company’s press release, this multicenter, double-masked, randomized, vehicle-controlled, parallel-group clinical trial will evaluate safety, tolerability, and efficacy of two doses of A197. The study will enroll about 200 patients with the primary endpoint being change from baseline in corneal fluorescein staining. The secondary endpoint will be eye dryness symptoms on the visual analog scale.

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Licensing agreement for optic nerve-protective therapy

Oculis announced a licensing agreement with Accure Therapeutics for ACT-01 (being renamed OCS-05), a potential neuroprotective agent that, according to the company’s press release, has shown positive effects on neuroinflammation and neurodegeneration in animal models. Oculis stated that this therapy could protect nerve axons in conditions where the optic nerve could be affected, as in optic neuritis or glaucoma. According to the press release, the therapy is designed to activate trophic factor pathways (IGF-1 and BDNF).

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Phase 3 study to evaluate protein replacement solution for dry eye

TearSolutions, after a Type C meeting with the FDA, will begin one of two Phase 3 trials for Lacripep later this year (enrollment in July 2022) with topline efficacy results expected in the first quarter of 2023. This first pivotal trial will evaluate Lacripep, a topical solution that preserves the bioactivity of the tear protein lacritin, in patients with dry eye associated with Sjogren’s disease. The study will enroll about 240 patients and have a primary endpoint of improvement in signs (inferior corneal fluorescein staining) and symptoms (burning and stinging) compared to baseline, according to the company’s press release. The company stated that beginning this first Phase 3 trial is subject to additional funding or partnership.

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Study: Impact of age on SMILE outcomes

A study published in the British Journal of Ophthalmology evaluated the influence of patient age on the refractive outcomes of small incision lenticule extraction (SMILE). The retrospective, consecutive, comparative study, included 102 matched eyes of 53 patients. Patients were divided into two groups based on age (those 35 years old or younger and those 40 years old and older). There was no difference preoperatively in mean spherical equivalent or astigmatism between the two groups. At 6 months post SMILE surgery, significantly worse mean astigmatism was observed in the older group with a trend toward under correction of cylinder. The authors also reported a statistically significant difference in efficacy and safety indexes at 1 month and 6 months postop between the two groups. The authors concluded that while the outcomes in the 40+ group were “acceptable,” they were not as good as the procedure outcomes at younger ages. “We hypothesize that the increased corneal stroma stiffness in the aged group modifies the post-SMILE corneal stroma remodeling capacity, thus affecting the SMILE refractive and visual response,” they wrote.

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ASCRS news and events

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Research highlights

  • Two eyes with advanced keratoconus and full-thickness, central pathology, scar, and failed graft were subjected to an alternative surgical technique: large-diameter penetrating keratoplasty with minimal endothelial replacement (PKMER). The paper published in Cornea described that both eyes, which had healthy endothelium at the periphery, were operated on with the PKMER technique with a retained central island of endothelium in the donor corresponding to the visual axis; the peripheral Descemet membrane was removed. “In effect, the peripheral endothelium and deep stroma of the recipient were preserved,” the authors wrote. One eye was followed up for 6 months and the other for 3 years. Both eyes maintained clear, central corneas, and astigmatism was significantly reduced. BCVA improved from hand motion to 6/12/n8 in one eye and 6/12/n12 in the other. Interfaces observed with anterior segment OCT tomography were satisfactory throughout follow-up, according to the authors. The authors also reported that both eyes underwent phaco for pre-existing cataracts after the PKMER procedure. With these results, the authors concluded that PKMER could be an alternative to large diameter, full-thickness keratoplasty. 
  • A perspective published in the American Journal of Ophthalmology analyzed the clinical, epidemiological, and biophysical data available for blue-filtering optical chromophores. The authors wrote that the term “blue light hazard” has been “misused commercially to suggest, falsely, that ambient environmental light exposure causes phototoxicity to the retina.” According to the paper, large epidemiological studies don’t support a decrease in AMD risk or progression with blue light-blocking IOLs. The authors continued that these lenses do not reduce glare, and they go on to discuss some of the benefits of blue light exposure. “Blue light hazard misrepresentation flourishes despite absence of proof that environmental light exposure or cataract surgery causes AMD or that IOL chromophores provide clinical protection,” the authors stated in the paper. “Blue-filtering chromophores suppress blue light critical for good mental and physical health and for optimal scotopic and mesopic vision.”

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Product news

  • STREAMLINE Surgical System (New World Medical), a single-use device that creates goniotomies in the trabecular meshwork and delivers a small amount of OVD into Schlemm’s canal, will become fully commercially available on April 1. Phase 4 studies are in progress.

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This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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