EW Weekly, October 2, 2020

FDA approves preservative-free antihistamine drop
The FDA approved Bausch + Lomb’s Alaway Preservative Free (ketotifen fumarate), 0.035%, an antihistamine drop for itching associated with allergies. According to the company’s news release, this is the first FDA-approved over-the-counter drop in a preservative-free formulation to be approved for itching associated with pollen, ragweed, grass, and animal hair and dander. The company stated that it acquired the rights for Alaway from Elton Pharmaceuticals in 2019.

FDA accepts IND for dry eye drop
Aerie Pharmaceuticals announced FDA acceptance of its Investigational New Drug (IND) application for AR-15512 for dry eye, allowing the company to begin clinical studies with the drop. According to the company’s news release, it plans to initiate a Phase 2b clinical study in the fourth quarter of 2020. The active ingredient in AR-15512 is an agonist of TRPM8 cold thermoreceptor ion channel, which the company’s press release explains regulates tear production and blink rate. A Phase 2a study was completed in 2019 with positive results to support the potential of the compound treating the signs and symptoms of dry eye. AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 with the company’s acquisition of Avizorex Pharma.

First patient dosed in Phase 2 clinical trial for cyclosporine intracanalicular insert
Ocular Therapeutix announced the first patient to receive OTX-CSI, a cyclosporine intracanalicular insert, to treat dry eye as part of its Phase 2 clinical trial. The Phase 2 trial is based in the U.S., randomized, masked, and multicenter. It will evaluate two formulations of OTX-CSI in more than 100 patients who will be followed out to 16 weeks. The Phase 2 trial will continue to assess safety, tolerability, durability, and efficacy, according to the company’s press release.

Orphan drug designation granted for treatment of Leber hereditary optic neuropathy
Neurophth Therapeutics was granted an orphan drug designation for NR082 for treatment of Leber hereditary optic neuropathy (LHON) associated with an ND4 mutation. According to the company’s press release, 70–90% of LHON is caused by this mutation. The NR082 treatment is an adeno-associated vector-based gene therapy. According to the company’s press release, this treatment would express the human ND4 gene in the retinal ganglion cells to repair optic neuropathy caused by 11778 G>A mutation. The latest clinical study from 2017–2018 with 159 patients (143 of whom completed 12 months of follow-up) showed 56.6% had a significant improvement of at least 0.3 logMAR in BCVA. There were no serious adverse reactions. The company’s press release stated that it is preparing Investigational New Drug applications in the U.S. and China to allow for clinical trials to evaluate safety, efficacy, and durability of NR082 gene therapy.

New program launched for development of presbyopia-correcting eye drop
Visus Therapeutics launched a clinical development program for a novel eye drop to restore near vision loss associated with presbyopia. The drug in development is BRIMOCHOL. According to the company’s press release, there have been five clinical studies evaluating the safety and efficacy of BRIMOCHOL, the most recent of which included 57 patients who saw improvement of near visual acuity of a 5 Jaeger line or greater, with effects lasting as long as 12 hours. According to the company, Phase 2 clinical trials are planned for early 2021.

Research briefs
  • Researchers who sought to describe and summarize outcomes of randomized controlled trials of multifocal vs. monofocal IOLs concluded that a core outcome set is needed because there is “considerable heterogeneity in the collection and reporting” on this topic in medical literature. This results in difficulty to estimate the effect and it “is a potential source of research waste,” the investigators wrote. All randomized controlled trials of multifocal vs. monofocal lenses in a Cochrane review were identified. Half of the studies reported data as a continuous measure, one-third reported as continuous and categorical measures, and a small number reported only categorical measures. The researchers also noted little consensus for study cut points. The study authors propose an initial core outcome set that could be used in studies going forward. This paper was published in the British Journal of Ophthalmology.
  • With a mean wait time of 153 days (plus or minus 101 days) for crosslinking, 39.6% of eyes were found to progress in a prospective observational study of 96 eyes of 96 patients with keratoconus. The researchers observed significant differences in index of surface variance, index of vertical asymmetry, keratoconus index, and index of height decentration in eyes that progressed during this wait time vs. those that remained stable. They did not see significant differences in steepest keratometry, average keratometry, cornea thinnest point, or center keratoconus index. Age, atopy/atopic keratoconjunctivitis, eye rubbing, and wait time were not significant risk factors for progression, but Maori ethnicity was determined a risk factor. The authors concluded that risk stratification for patients waiting for crosslinking could reduce risk of progression during this timeframe. The research is published in the journal Cornea.

Product News
  • Johnson & Johnson Vision launched the TECNIS Synergy Toric II, a continuous range of vision and astigmatism-correcting IOL, and the CATALYS c0s 6 software, with features for improved astigmatism management workflow, in Europe.
  • CLEAR (Corneal Lenticule Extraction for Advanced Refractive Correction), an application integrated in Ziemer’s FEMTO LDV Z8, received the CE mark.
  • Micro Labs USA, a producer of generic medicines with FDA-approved facilities in India, announced its launch of dorzolamide HCL ophthalmic solution, 2%, and dorzolamide-timolol maleate ophthalmic solution, 22.3mg/6.8 mg/mL.
  • Konan Medical and Konan Medical USA launched CellChek 20, an endothelial imaging system that is FDA approved and CE marked.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

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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