EW Weekly, February 19, 2021

Investigating adjuvant therapy to DSO for Fuchs
A Phase 2 clinical trial has begun to evaluate TTHX114, an engineered fibroblast growth factor-1 by Trefoil Therapeutics, as an adjuvant therapy to Descemet’s stripping only (DSO) for Fuchs endothelial corneal dystrophy. The trial is open label with 40+ patients who were already scheduled for DSO; one group will have DSO alone to serve as a control and another group will have DSO and receive TTHX114 intracamerally. TTHX114, according to the company’s press release, is designed to stimulate cell proliferation and migration and protect cells from stress/injury.

FDA approves loteprednol etabonate ophthalmic gel
Akorn Operating Company has received FDA approval for its loteprednol etabonate ophthalmic gel. According to the company’s press release, this is a first-to-market generic indicated for treatment of postop inflammation and pain following ocular surgery.

Pilot study: Photobiomodulation improves BCVA in patients with dry AMD
Interim data from a prospective pilot study of the Valeda Light Delivery System, a photobiomodulation treatment being developed by LumiThera, showed an increase in electrical activity in the retina and corresponding BCVA improvement in patients with dry AMD. Twenty-three eyes from 15 patients with intermediate dry AMD were enrolled, according to the company’s press release, and were treated with the Light Delivery System three times a week for 3 weeks. Electrical activity was measured with an electroretinogram. The company stated that there was a 14.4% improvement from baseline in electroretinogram activity after 1 month, which was significant, and a positive correlation with BCVA. More specifically, patients saw a 12.6±1.25-letter improvement in BCVA compared to baseline. Contrast sensitivity was also improved. Outcomes will continue to be followed to 6 months.

Positive interim data in trial for gene therapy for GA
Positive interim data was reported by Gyroscope Therapeutics for its investigational gene therapy GT005 for geographic atrophy (GA) secondary to AMD. The Phase 1/2 dose-response trial found that the therapy was well tolerated and showed an increase in complement factor 1 in most patients in the vitreous, in addition to decreases in complement proteins associated with overactivation of the system. The company’s press release explained that GT005 is designed to restore balance to an overactive complement system by increasing production of the CFI protein, which regulates this system and can reduce inflammation.

Four Phase 3 studies of faricimab show up to 4-month treatment intervals for DME and wet AMD
Genentech announced results from four Phase 3 studies of faricimab for treatment of DME and wet AMD (neovascular AMD, nAMD), which ultimately showed that the visual gains with this bispecific antibody, given up to every 4 months, were not inferior to aflibercept, given every 2 months. Half of the patients eligible for extended dosing in the first year of the two DME studies and two nAMD studies were able to effectively receive faricimab every 4 months, according to the company’s press release; three-quarters achieved a dosing schedule of every 3 months or longer. This, the company continued, makes faricimab the first injectable ocular drug to achieve this time between intervals in Phase 3 studies for these conditions. The press release stated that Genentech plans to submit the results from these studies to the FDA and European Medicines Agency for consideration of regulatory approval.

Research highlight
  • A study published in Radiology described ocular abnormalities seen in a few cases of patients who experienced severe COVID-19 symptoms. The retrospective, multicenter, observational study involved nine patients who showed globe abnormalities on MRI (out of 129 patients with severe COVID-19 from March 4–May 1, 2020, who were evaluated with MRI). The nine patients who had globe abnormalities all showed nodules in the macular region; eight out of the nine patients had bilateral nodules and two had nodules outside the macular region, the paper reported. A press release about the paper suggested screening patients with severe COVID-19 with high-resolution MRI to detect such nodules, which could otherwise go unnoticed. The mechanism for development of these nodules is not yet known, but researchers hypothesized that it could be related to inflammation or inadequate drainage from ocular veins in patients who might be in a prone position or intubated (seven of the nine patients with the nodules in this study were in a prone position for a length of time), according to the press release. Further research will include MRI on patients with mild to moderate COVID-19 symptoms to see if similar nodules are present.
  • A single-center retrospective study of 140 eyes from 70 patients sought to evaluate whether there were predictive factors for photic phenomena (glare and halo) in those who were bilaterally implanted with trifocal IOLs (PanOptix, Alcon). The lenses were implanted between 2017–2019, and patients were followed for 6 months with information on refraction, corneal topography, and aberrometry pre- and postop being collected. A patient satisfaction survey that included questions about photic phenomena was also performed. Multivariate regression analyses found only one predictor of photic phenomena: baseline visual acuity. The investigators wrote that patients with better baseline visual acuity might have higher expectations for their postop visual outcomes. The research is published in Clinical Ophthalmology.

Product news
  • New World Medical announced the commercial launch of Kahook Dual Blade (KDB) Glide for advanced excisional goniotomy for treatment of glaucoma.

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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