EyeWorld Weekly, December 3, 2021

EyeWorld Weekly, December 3, 2021

December 3, 2021 • Volume 27, Number 47

Positive topline clinical data for investigational topical presbyopia treatment

Visus Therapeutics announced positive topline results from its Phase 2 VIVID study that evaluated three topical ophthalmic formulations for temporary treatment of presbyopia. According to the company’s press release, all three formulations of BRIMOCHOL (carbachol/brimonidine tartrate), BRIMOCHOL F (carbachol/brimonidine tartrate), and Carbachol F achieved the primary endpoint (three lines of improvement in binocular near visual acuity under mesopic conditions without losing a line of distance vision) at 1 hour, with a minimum responder rate of 83%. A minimum responder rate of 52% and 35% at this same endpoint for all three formulations was achieved at 7 and 9 hours, respectively. As a secondary endpoint, BRIMOCHOL and BRIMOCHOL F achieved a mean binocular near visual acuity improvement of at least 18 ETDRS letters (nearly four lines) as early as 30 minutes and a minimum of 12 letters at 9 hours. All three formulations were well tolerated. Adverse events exceeding 5%, according to the company, included temporary burning and stinging upon instillation, headache, and brow ache. Visus stated that it would begin Phase 3 pivotal trials soon.

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FDA grants IDE for modular IOL with fluid-filled optic

LensGen announced that the FDA approved an IDE for it to begin a pivotal study with its Juvene IOL. According to the company’s press release, Juvene is a modular IOL with a fluid optic component that changes shape to adjust focus. The company described the lens as mimicking the function of the natural human lens, which could restore vision, including accommodation lost due to presbyopia, with cataract surgery.

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First participants enrolled in Phase 3 trial for mydriasis reversal

Ocuphire Pharma announced that the first subjects were enrolled in its Phase 3 MIRA-3 pivotal trial evaluating Nyxol (0.75% phentolamine mesylate) for reversal of pharmacologically induced mydriasis. According to the company’s press release, MIRA-3 is multicenter, randomized, parallel-armed, double-masked, and placebo-controlled. It will evaluate safety and efficacy of Nyxol in about 330 subjects ages 12 and older. The effect of Nyxol will be evaluated after mydriasis is induced with 2.5% phenylephrine, 1% tropicamide, or Paremyd (hydroxyamphetamine hydrobromide 1% and tropicamide 0.25%, Akorn Pharmaceuticals). The study’s primary efficacy endpoint is percentage of eyes returning to ≤0.2 mm from baseline photopic pupil diameter at 90 minutes, according to the company. Secondary endpoints include pupil diameter at multiple timepoints, accommodation, a patient questionnaire, glare disability, glare tolerability, and pupillary response to light, the company’s press release reported. Topline results are expected within the first quarter of 2022.

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Analysis: Subgroup of dry eye patients benefit from investigational treatment

Nicox announced post hoc results from its Mississippi 2b clinical trial of once-daily NCX 4251 (fluticasone propionate ophthalmic suspension 0.1%) that found a subgroup of patients (those who scored 2 or more at baseline for inferior corneal staining on a scale from 0 [none] to 4 [severe]) showed a statistically significant difference against placebo in improvement from baseline in eye dryness scores assessed on a Visual Analog Scale at days 8, 11, and 15. Statistically significant differences were also observed in photophobia, blurred vision, burning/stinging, foreign body sensation, ocular itching, and pain at the same timepoints. According to the press release, the company is expected to meet with the FDA in early 2022, at which point next steps for the development of NCX 4251 will be announced.

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NDA approved for generic drug designed to treat inflammation, pain

Amneal Pharmaceuticals announced that it received an Abbreviated New Drug Application (NDA) from the FDA for difluprednate ophthalmic emulsion 0.05%, the generic version of Durezol (Novartis). The corticosteroid is used for the treatment of inflammation and pain associated with ocular surgery.

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First patient enrolled in Phase 2a study for wet AMD and DME candidate

Isarna Therapeutics announced that it began enrollment for its Phase 2a BETTER study, which will evaluate the company’s lead candidate ISTH0036 in patients with wet AMD and DME. The study, according to the company’s press release, is enrolling patients at centers in Austria and India, gathering data on the reduction of retinal fluid and central macular thickness as the primary endpoint and improvement in visual acuity during the 7-month treatment period as a secondary endpoint. A 2-month safety study will follow the treatment period.

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ASCRS news and events

  • ASCRS remembers the life of Emanuel Rosen, MD, FRCSEd, former editor of JCRS, who passed away on November 20. Read the full obituary.
  • 2022 ASCRS Annual Meeting: Tier 1 registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, is open. There is also a call for complicated case video submissions. 
  • ASCRS Grand Rounds: The next ASCRS Grand Rounds presented by the University of Iowa Department of Ophthalmology and Visual Sciences will become available on Monday, December 6. 
  • ASCRS Journal Club: Two pre-selected JCRS manuscripts will be discussed in the next Journal Club taking place Thursday, December 9 from 9:00–10:00 p.m. ET. 
  • ASCRS Winter Symposium: Registration is open for the February 10–12 Winter Symposium in Park City, Utah. The meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology.

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Research highlights

  • A single-center, prospective, randomized, contralateral eye-controlled trial published in the American Journal of Ophthalmology compared wavefront-guided LASIK and SMILE. Eighty-eight eyes (44 patients) with myopia and low-level astigmatism were enrolled with treatments randomized based on ocular dominance. According to the study, 74 eyes (37 patients) had successful treatments and completed 12 months of follow-up. At 12 months postop, the study authors reported a significantly higher proportion of eyes in the wavefront-guided LASIK group with more than 20/20 UDVA compared to SMILE (94% and 83%, respectively). There was no difference in spherical equivalent between the groups, as well as no difference in HOAs. More eyes treated with wavefront-guided LASIK improved 5% and 25% in low-contrast visual acuity compared to SMILE-treated eyes. The authors concluded that both procedures offer improved distance visual acuity and predictability. They continued that wavefront-guided LASIK resulted in faster visual recovery, better low-contrast visual acuity, and better UCVA. 
  • A multicenter, randomized, parallel-group, single-blind clinical trial published in the journal Ophthalmology evaluated the safety and efficacy of repeated low-level red-light (RLRL) therapy as a tactic for pediatric myopia control. Two hundred and sixty-four children 8–13 years old with myopia of –1 to –5 D, astigmatism of 2.5 D or more, anisometropia of 1.5 D or more, and BCVA of 20/20 were enrolled in the trial and randomly assigned to the RLRL intervention group with a single-vision spectacle or the control group with a single-vision spectacle alone. The RLRL treatment consisted of an at-home, desktop, light therapy device that emitted red light at a 650-nm wavelength with an illuminance level of 1600 lux and power of 0.29 mW. The treatment group received RLRL therapy twice per day for 3 minutes each time for 5 days a week. According to the study, 246 patients were included in the analysis, 117 of whom received RLRL therapy and 129 in the control group. The authors reported adjusted 12-month axial elongation and spherical equivalent refraction were 0.13 mm and –0.2 D, respectively, in the treatment group and 0.38 mm and –0.79 D in the control group. There were no serious adverse events, functional vision loss, or structural damage, according to the study. The authors concluded that RLRL is a promising therapy for myopia control.

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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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