EW Weekly, April 9, 2021

Researchers develop living 3D lab model of human retina
Researchers at the University of Rochester announced development of a 3D lab model that combines stem cell-derived retinal tissue and vasculature with synthetic materials. This model will be used to investigate wet AMD and potential therapies. More specifically, the researchers developed a retinal pigment epithelium (RPE)-choriocapillaris complex, described in the journal Cell Stem Cell, with the ability to exhibit features of both healthy eyes and of AMD or other macular dystrophies. Potential therapeutic targets were identified in the research as well. According to the university’s press release, research involving this model could help identify whether retinal defects cause AMD or whether it is caused by systemic issues. Current research from the university supports the former theory, with defects in the retinal pigment epithelium specifically implicated, according to the press release.

Real-world data shows home AMD monitoring program is better than standard of care
Notal Vision announced real-world performance data of its ForeseeHome AMD Monitoring Program, which according to the company’s press release, showed improvement over the standard of care for detecting the condition at a stage when a better visual acuity could be preserved with earlier treatments. The retrospective analysis published in the Journal of Clinical Medicine included 3.2 million tests performed by nearly 9,000 patients; data was compared to the AREDS2-HOME study. The research identified 306 eyes that converted from intermediate AMD to wet AMD from 2009–2018. Eighty-one percent of patients using ForeseeHome who developed wet AMD maintained functional vision of 20/40 or better vision compared to 34% of patients using standard of care office visits and Amsler grid tests.

FDA approves new ophthalmic viscosurgical device
Bausch + Lomb announced FDA approval of a new dispersive ophthalmic viscosurgical device (OVD), ClearVisc. In addition to mechanical and thermal protection, Bausch + Lomb’s press release stated that ClearVisc includes sorbitol, described as a chemical agent that has been shown to provide protection against free radicals, which can cause corneal damage, compared to other dispersive OVDs.

Positive topline data for photobiomodulation for dry AMD
LumiThera announced positive topline data from the LIGHTSITE II prospective, doubled-masked, randomized, multicenter, EU post-marketing trial for its photobiomodulation treatment for dry AMD. Thirty-two eyes were treated with photobiomodulation and 19 received sham treatment. There was a statistically significant improvement in best-corrected visual acuity at 9 months from baseline in the group that received photobiomodulation treatment with no safety issues identified after three rounds of treatment at 4-month intervals. According to the company’s press release, mean visual benefit of the photobiomodulation group vs. sham group at 9 months was a 4-letter vs. 0.5-letter gain. The company recently completed enrollment in a companion U.S.-based trial to support possible FDA approval in the future.

Positive topline data for bevacizumab-vikg for retinal indications
Outlook Therapeutics announced topline results from its NORSE THREE open-label safety study of ONS-5010/LYTENAVA (bevacizumab-vikg) for retinal diseases. There were no unexpected safety trends, and the safety profile was consistent with prior data on bevacizumab for ophthalmic conditions, according to a press release from the company. Adverse events occurred in 10% of eyes, most commonly associated with the injection procedure and not the drug itself. No serious adverse events occurred, and the press release noted zero cases of ocular inflammation. Patients enrolled in this study had a range of retinal diseases, such as wet AMD, DME, and BRVO. Some were treatment naive and others had previously received anti-VEGF treatments. If its pivotal trial NORSE TWO for wet AMD is successful, Outlook Therapeutics plans to submit a biologics license application to the FDA later this year under the PHSA 351(a) regulatory pathway.

Research highlights
  • Standalone iStent (Glaukos) and iStent inject (Glaukos) in patients with open-angle glaucoma was evaluated in a study published in the Journal of Glaucoma. This systematic review included 13 randomized and non-randomized studies with at least 6 months of follow-up and more than 10 eyes. The research described a weighted mean IOP reduction of 31.1% at 6–12 months in eyes that received iStent. Studies that included longer-term outcomes showed similar IOP reductions, 30.4% at 36–48 months and 32.9% at 60 months. Pooled weighted mean IOP reduction from baseline was 7.1 mm Hg at 6–12 months and 6.59 mm Hg at 36–60 months. Medications were reduced by 1.0 at 6–18 months and 1.2 at 36–60 months. Adverse events occurred in more than 5% of participants and included progression of a pre-existing cataract/cataract surgery and loss of BCVA; the investigators stated these rates are similar to comparative medical therapy study arms. The investigators wrote that these results support standalone iStent procedures.
  • A retrospective cohort study published in the journal Eye evaluated hormonal contraceptive use and dry eye disease. Using data from IQVIA’s electronic medical record, researchers identified more than 4.8 million women 15–45 years old who between 2008–2018 were followed to their first diagnosis of dry eye disease with an ICD-9/10 code. The research included cases who had at least two prescriptions for cyclosporine or lifitegrast within 60 days of being diagnosed with dry eye disease. The date of this first diagnosis was considered the index date by researchers. At least two prescriptions for hormonal birth control in the first and second year prior to the index date were required for data to be included in the analysis. Five age-matched controls with similar follow-up time were selected for each case and use for comparison. The investigators found that patients who used hormonal birth control were at higher risk for dry eye disease compared to those who didn’t use birth control, and regular users of birth control were more likely to develop the ocular condition than irregular users.

Product news
  • Santen is launching PURALID LIPOGEL, an ophthalmic gel for blepharitis, in several European countries.
  • Horizon Therapeutics announced plans to resupply the market with Tepezza (teprotumumab) for thyroid eye disease following FDA acceptance of the prior approval supplement to its previously approved Biologics Licensing Application.

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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