EW Weekly, January 29, 2021

Topline results from Phase 3 studies for nAMD treatment
Genentech announced positive topline results from two of its Phase 3 studies of faricimab as a possible treatment for neovascular (or wet) AMD (nAMD). According to the company’s press release, faricimab is a bispecific antibody that targets angiopoietin-2 and VEGF-A, which drive several retinal conditions. If faricimab were eventually approved, it would be the first in a new class of medicine to treat nAMD in more than 15 years, the company stated. Some of the results included faricimab meeting its primary endpoint of average change in BCVA from baseline at 1 year compared to aflibercept; non-inferiority of visual acuity with faricimab injected up to every 16 weeks compared to aflibercept injected every 8 weeks; durability of faricimab with 45% of recipients being treated every 16 weeks; and general safety and tolerability of faricimab maintained.

Phase 2 trial of betamethasone treatment for cataract surgery pain and inflammation
Surface Ophthalmics announced positive Phase 2 topline results from its study of an investigational 0.2% betamethasone treatment for pain and inflammation after cataract surgery. According to the company’s press release 91 patients were enrolled to receive SURF-201, which is the corticosteroid formulated with the company’s Klarity vehicle, dosed twice daily. The trial showed complete clearance of anterior chamber cells, a marker of inflammation, at day 8 and day 15. Nearly 90% of patients were pain-free at day 15 as well, the company’s press release stated. There were no incidents where IOP increased more than 10 mm Hg from baseline or exceeded 22 mm Hg.

Fast Track designation given to therapy seeking to treat achromatopsia
The FDA has granted Fast Track designation to MeiraGTx for AAV-CNGA3, a gene therapy for treatment of achromatopsia caused by mutations in the CNGA3 gene. The company’s press release stated that this investigational therapy is designed to restore function to cones after being delivered to these photoreceptors via subretinal injection. MeiraGTx, which is developing AAV-CNGA3 jointly with Janssen Pharmaceuticals, is conducting an open-label, dose escalation Phase 1/2 trial. According to the company, AAV-CNGA3 already has an FDA Orphan Drug designation and a designation as a potential therapy for a rare pediatric disease.

Topline data from Phase 1 trial of travoprost intracameral implant
Interim topline data from a Phase 1 trial of OTX-TIC (travoprost intracameral implant) was announced by Ocular Therapeutix. According to the company’s press release, data from the prospective, multicenter, open-label clinical trial includes four fully enrolled cohorts, all of which experienced a mean reduction in IOP from baseline (7–11 mm Hg). Onset of action took place as early as 2 days after insertion, the company stated, with durability lasting 6+ months. The implant biodegraded within 5–7 months in the first two cohorts and within 3–5 months in the latter two. There were no serious adverse events. According to the press release, the company plans to begin a Phase 2 clinical trial later this year.

ASCRS Journal Club
Join ASCRS for the next Journal Club, taking place on Thursday, February 11 at 9:00 PM ET. It will feature Haripriya Aravind, MD, presenting “Comparison of surgical repositioning rates and outcomes for hydrophilic vs. hydrophobic single-piece acrylic toric IOLs,” as well as Nhon Le, MD, presenting “Diffuse lamellar keratitis after LASIK with low-energy femtosecond laser” from the February issue of the Journal of Cataract & Refractive Surgery. Panelists will include David Chang, MD, Nicole Fram, MD, and Andrew Sorenson, MD.

Research highlights
  • A retrospective review is offering caution of increased incidence of accidental ocular exposure to hand sanitizer due to its increased use during the COVID-19 pandemic. The review was conducted with data from the French national poison control database. The study authors compared data from 2019 to 2020 and found alcohol-based hand sanitizer ocular exposure in children occurred seven times more frequently during a period of time in 2020. The report also reviewed data on admissions to eye hospitals for exposure to alcohol-based hand sanitizer, finding an increase in the 2020 time period reviewed compared to 2019. With these findings, the authors noted the importance of vigilance in the safe use (and storage) of alcohol-based hand sanitizer with children. The paper is published in JAMA Ophthalmology.
  • A case series published in the journal Cornea described the novel use of a topical rho-kinase inhibitor (netarsudil) in patients with corneal edema secondary to endothelial cell dysfunction. The series included four patients at an academic clinical practice who received one drop of netarsudil daily in the presenting eye. The paper described corneal clearance after 4 weeks in a case of corneal edema in an eye with iridocorneal endothelial syndrome, clearance after 2 weeks in the setting of early PK graft failure, and 4 weeks after chronic PK graft failure. The fourth patient with pseudophakic bullous keratopathy after lens exchange surgery with an ACIOL did not achieve corneal clearance after 12 weeks with netarsudil. With these findings, the authors concluded that use of a topical rho-kinase inhibitor could aid corneal clearance in a variety of endothelial cell dysfunction case.
  • Research published in the British Journal of Ophthalmology is linking air pollution to a higher risk of AMD. The cross-sectional study included more than 115,000 people in the U.K. Biobank 40–69 years old who self-reported AMD diagnoses. Particulate matter, nitrogen dioxide, and nitrogen oxide were measured for ambient air pollution. SD-OCT was obtained in more than 52,600 participants for measures of retinal sublayer thickness to be used as biomarkers for AMD. The study authors explained that after adjusting for covariants, participants who were exposed to ambient particulate matter greater than 2.5 µm were more likely to self-report AMD and to have retinal structural changes indicative of AMD. A press release about the research noted an 8% difference in AMD risk when comparing those who lived in the 25th and 75th percentiles of pollution levels. It also noted that all measures of air pollutants included in the study (except coarse particulate matter) were associated with change in retinal structure.

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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