EW Weekly, July 10, 2020

FDA accepts PMA application for Santen’s DE-128
Santen announced FDA acceptance of its Premarket Approval (PMA) application for DE-128 (the PRESERFLO MicroShunt as it is marketed in Europe where it already has CE approval, formerly known as the InnFocus MicroShunt). DE-128 is a biocompatible, flexible, 8.5-mm tube that is designated by the company as an ab-externo MIGS implant. It was investigated for patients with primary open angle glaucoma with IOP uncontrolled on maximum medical therapy.

Phase 3 clinical trial for proposed aflibercept biosimilar
Samsung Bioepsis initiated a Phase 3 clinical trial for SB15, a proposed biosimilar for aflibercept (Eylea, Regeneron) to treat patients with neovascular AMD. The trial seeks to enroll 446 participants and will be randomized, double-masked, parallel group, and multicenter, comparing the efficacy, safety, pharmacokinetics, and immunogenicity of SB15 and Eylea, according to a Samsung Bioepsis press release.

Gene therapy for Leber hereditary optic neuropathy demonstrates sustained efficacy, safety
A long-term follow-up study of patients with Leber hereditary optic neuropathy (LHON) who received LUMEVOQ (GenSight Biologics), a single injection gene therapy, showed that 3 years post-treatment, they maintained the mean improvement of letters gained (+20.5 letters equivalent in LUMEVOQ-treated eyes and +19.4 letters equivalent in sham-treated eyes). Three years out there were no serious adverse events in eyes treated with the gene therapy and no serious systemic effects associated with LUMEVOQ, the company reported in a press release.

Study: Eye drops prevent damage from retinal vein occlusion in mice
A recent study showed that eye drops were able to prevent vision loss after retinal vein occlusion in mice. The research by Maria Avrutsky, PhD, and coinvestigators showed first how endothelial caspase-9 is activated after hypoxia-ischemia, leading to retinal neurodegeneration. Applying a selective, topical caspase-9 inhibitor provides protection to both the structure and function of the retinal cells, Avrutsky et al. described in Nature Communications. The authors reported reduced edema and inflammation as well with the inhibitor. According to a news release from Columbia University, the eye drop will move into a Phase 1 human trial, and researchers are looking at whether caspase-9 inhibitors can be used in other vascular injuries as well.

AAO to launch open-access journal
AAO announced its plan to launch its first open-access journal, Ophthalmology Science, in 2021. According to a press release from AAO, the online-only, quarterly journal will focus on publishing pre-clinical development, Phase 1 and Phase 2 clinical trials, laboratory-based work, ophthalmology informatics, and clinical science.

Register for the Winning Pitch Challenge
ASCRS is hosting the Winning Pitch Challenge symposium on Saturday, July 18 at 2 p.m. ET. The Winning Pitch Challenge features entrepreneurs who share their innovative ideas that could advance ophthalmology with leading experts in the field. The winner receives $25,000 and expert guidance as they try to bring their concept to fruition. Moderators will be Vance Thompson, MD, and Edward Holland, MD. Judges will be William Link, PhD, Richard Lindstrom, MD, Juliet Bakker, and Jim Mazzo. Click here to register for the event.

Research highlights
  • A study that looked at exercise in mice and its effect on choroidal neovascularization (CNV) is the first published experimental evidence to show voluntary exercise improves outcomes. The research published in Investigative Ophthalmology and Vision Science described how age-matched, wild-type C57BL/6J mice were put in cages with and without running wheels for 4 weeks. After these 4 weeks, the mice were exposed to laser injury to induce CNV. The mice that had the opportunity to exercise showed a 45% reduction in CNV volume compared to the sedentary mice, Makin et al. reported. The researchers conducted a replication study and saw a 32% reduction in CNV volume in the mice that exercised prior to the induced injury. The study authors, combining these studies, found that voluntary exercise appears to reduce CNV by 41%. They noted in the study that daily running distance was not correlated with CNV lesion size and that exercise post-injury (without exercise prior) did not affect CNV size. “These studies indicate that exercise before laser treatment is required to improve CNV outcomes,” Makin et al. concluded.
  • A retrospective, consecutive case series evaluated the long-term safety and efficacy of iStent (Glaukos) combined with cataract surgery in patients with mild to severe primary open angle glaucoma. Data was collected out to 6 years postop. The study included 411 eyes and IOP was reduced by a mean of 14.9±4.2 mm Hg (compared to 18.8±5.6 mm Hg at baseline) at 6 years postop. Eyes with more severe disease saw a mean IOP reduction of more than 6 mm Hg at 6 years postop, and eyes with a baseline IOP of 18 mm Hg or higher saw a more significant IOP reduction. Though there were no intraoperative or postoperative complications, Ferguson et al. reported 15 eyes going on to have a secondary glaucoma procedure during the follow-up timeframe. The research is published in Clinical Ophthalmology.
  • A study published in Eye evaluated methods to reduce visible aerosol generation during phacoemulsification surgery on a human cadaveric eye. Darcy et al. point out that reducing aerosols is of interest in the COVID-19 pandemic. The researchers found that a 2.2 mm phaco tip did not generate visible aerosols but a 2.75 mm tip did. They also evaluated suction near the aerosol plume but reported that this action “did not impact its dispersion.” Blowing air was able to redirect the aerosol plume to the ocular surface, but more notably, the researchers reported that using a hydroxypropyl methylcellulose (HPMC) coating on the cornea eliminated visible aerosol.

Product new
  • The EVO Viva presbyopia-correcting ICL (STAAR Surgical) received the CE mark.
  • Novartis withdrew its marketing authorization application with the European Medicines Agency for Xiidra (lifitegrast).
  • Haag-Streit launched a new, CE-registered, swept source-based OCT analyzer, the Eyestar 900.
  • OcuBlink introduced a synthetic eyeball for testing AV/VR systems.

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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