EW Weekly, August 14, 2020

First patient enrolled in trial for stand-alone glaucoma surgery
Sight Sciences announced that it had enrolled its first patient in its prospective, multicenter trial for the OMNI Surgical System, a MIGS option that is intended to take place as a stand-alone procedure (not necessarily in combination with cataract surgery) for patients with mild to moderate glaucoma. The primary efficacy endpoint of the ORION trial will be the proportion of eyes with at least a 20% decrease in unmedicated mean diurnal IOP at 12 months, according to a press release from the company. Secondary endpoints will include mean change in unmedicated diurnal IOP from baseline and proportion of eyes that reach between 6 and 18 mm Hg unmedicated. The trial will include 110 patients across 10 study sites. According to the company, the OMNI system combines ab interno trabeculotomy and transluminal viscoelastic delivery.

Fourth Orphan Drug Designation for OCU400
Ocugen received its fourth Orphan Drug Designation (ODD) from the FDA for OCU400. According to the company, this ODD is for treatment of PDE6B gene mutation-associated retinal diseases. It comes on the heels of receiving an ODD for RHO mutation-associated retinal degeneration last week. The OCU400 platform is a gene therapy candidate, which in this case carries a functional nuclear hormone receptor gene, NR2E3, targeted to retina cells via an adeno-associated viral vector, according to the company’s press release. The company goes on to describe OCU400 as a single product candidate that has the potential to address broad-spectrum retinitis pigmentosa.

Bausch + Lomb to separate from Bausch Health
Bausch Health decided to spin off Bausch + Lomb, its eyecare company, into an independent, publicly traded entity. According to a news release from the company, Bausch + Lomb will include Bausch Health’s global vision care, surgical, and ophthalmic prescription businesses.

20/Happy in 2020: ASCRS launches master class
ASCRS is launching “20/Happy in 2020: The ASCRS Master Class in Refractive Cataract Surgery,” which includes 18 AMA PRA Category 1 Credits TM as well as non-CME symposia that attendees can view live or watch later at their own pace. Every other week, live symposia will be aired on Saturdays, avoiding conflicts with clinic and OR time. At the conclusion of the multi-week master class, participants will receive a frameable certificate. The nine CME modules will cover topics including preoperative diagnostics, IOL calculations, IOL design, patient selection, education, and counseling, efficiency, and more, with discussion and expertise provided by a faculty of 80 surgeons from around the world. Sessions will consist of lectures, audience Q&A, and live panel discussions. Attendees who don’t attend sessions live will have the opportunity to watch recorded versions. Learn more and register at https://ascrs.org/20happy.

Research highlights
  • Patients with primary open angle glaucoma with higher pressures are more likely to see a 20% or higher reduction in IOP with selective laser trabeculoplasty (SLT) than those with lower baseline pressures, according to research published in Scientific Reports. The retrospective review of 252 eyes of 198 patients who had SLT between July 2016 and February 2018 with at least 6 months of follow-up specifically found that those with a baseline IOP of more than 18 mm Hg were significantly more likely to have an average 23.7% reduction of IOP, compared to those with a lower baseline IOP who actually saw an average 4.9% increase in IOP at 6 months. Age, type, severity of glaucoma, pigmentation of the trabecular meshwork, and total energy delivered in the SLT treatment had no association with greater success of the procedure or with IOP spikes, the study authors reported.
  • A retrospective case report evaluated the 5-year clinical outcomes of Descemet’s stripping only (DSO) in a 55-year-old female patient with bilateral Fuchs endothelial cell dystrophy. The patient had 4-mm DSO procedures 6 months apart, with subjective vision, visual acuity, and corneal edema measured at 1 month, 3 months, 6 months, 12 months, 3 years, and 5 years. At 3 months postop, BCVA of 0.0 logMAR and corneal clearance was recorded. This condition remained out to 5 years. The case is published in the journal Cornea.
  • A retrospective study described biomechanical changes in the cornea upon LASIK flap creation that resulted in inaccurate ablations and thus patients who were unhappy with their refractive outcomes. The study detailed six patients who were treated with the Contoura topography-guided LASIK system (Alcon) with flaps created by the Alcon WaveLight FS200 femtosecond laser or Moria M2 microkeratome. According to the research, patients who experienced this biomechanical change upon flap creation, resulting in inaccurate LASIK treatments, showed an elliptical, irregular ablation on postop topography that “lateralized the thinnest point of the cornea relative to the corneal apex on Pentacam [Oculus] pachymetry maps, and irregular corneal epithelial thickening at the periphery of the elliptical ablation.” The study noted that Cynthia Roberts, MD, theorized this corneal alteration upon flap creation, now dubbed the “Roberts Effect.” Analysis of 266 eyes that received Contoura LASIK with the LYRA Protocol revealed 10% of eyes experienced the “Roberts Effect.” The author wrote that the “lateralized thin point relative to the apex combined with a thicker than average cornea is the major pre-disposing factor.” Discussions with the patient about this risk factor should be had, the author continued, with options including separating the flap creation and laser treatment, allowing for new Contoura scans, performing PRK, or using transepithelial ablation (the latter of which is not yet available in the U.S.). The research is published in the journal Clinical Ophthalmology.

Product news
  • FDA accepted Clearside Biomedical’s IND application for CLS-AX (axitinib injectable suspension). The company will begin a Phase 1/2a clinical trial of the suprachoroidal injection in patients with wet AMD by the end of 2020.
  • VSY Biotechnology launched the Enova IOL, which the company describes as the first glistening-free hydrophobic acrylic IOL that doesn’t require prehydration or saline storage.

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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