EW Weekly, June 7, 2019

Topline Phase 2 results announced for risuteganib for dry AMD
Topline Phase 2 results have been announced for risuteganib (Luminate, Allegro Ophthalmics) for dry age-related macular degeneration (AMD). The prospective, randomized, double-masked, placebo-controlled, multicenter study's primary endpoint was the proportion of subjects with 8 or more letters of vision gain with two risuteganib injections compared with one sham treatment. Forty-eight percent of patients in the risuteganib arm at week 28 and 7% in the sham group at week 12 met the primary endpoint (P=0.013). In the study, 40 patients were randomized at baseline to receive intravitreal 1.0 risuteganib or sham injection; patients in the risuteganib arm received a second dose at week 16. Risuteganib was safe, with no serious adverse events. Secondary outcomes are still under evaluation and will be announced in the coming weeks.

Dosing completed for Phase 1/2a trial for RGX-314 for wet AMD
Dosing has been completed across all five cohorts in a Phase 1/2a trial of RGX-314 (Regenxbio) to treat wet AMD, according to a company press release. Company leaders reported a durable treatment response from Cohort 3 of the trial at 1 year after a single administration of RGX-314 in a heavily pretreated patient population. Eight retinal surgery centers across the U.S. are participating in the study, which focuses on RGX-314 as a one-time therapy for wet AMD patients who previously used anti-vascular endothelial growth factor injections. A total of 42 dosed subjects are included, all of whom received RGX-314 via subretinal delivery. Topline data are expected by the end of the year, according to the company. A Phase 2b trial for wet AMD is planned by the end of the year, along with the filing of an Investigational New Drug application for RGX-314 for diabetic retinopathy.

3D printed artificial corneas similar to human eyes
Researchers in Korea have printed an artificial cornea using 3D printing and bioink made of decellularized corneal stroma and stem cells. "Because this cornea is made of cornea tissue-derived bioink, it is biocompatible, and 3D cell printing technology recapitulates the corneal microenvironment," according to a press release about the research. This artificial cornea has transparency similar to the human cornea. Researchers, led by Hyeonji Kim, also observed that collagen fibrils remodeled along with the printing path created a lattice pattern similar to the structure of the native human cornea after 4 weeks in vivo. Information about the printed cornea appears in the journal Biofabrication.

PRECEYES Surgical System receives CE mark
The PRECEYES Surgical System R1.1, a robot-assisted precision eye surgery system, has received a CE mark in Europe. The system helps surgeons during certain vitreoretinal surgery tasks.

ASCRS Foundation announces 4th annual National Sight Week
The ASCRS Foundation announced that it will host it's 4th annual National Sight Week initiative, October 20­­–26. Operation Sight is the ASCRS Foundation's U.S.-based charitable cataract surgery program. It is a nationwide network of ASCRS surgeons who provide care to those unable to access or afford cataract surgery on their own. Since its launch in late 2014, Operation Sight has delivered more than 3,350 free surgeries. This year the goal is to not only increase the number of charitable cataract surgeries, but to raise overall awareness of the Operation Sight program. The ASCRS Foundation provides administrative and other support to help lessen the burden associated with providing a charitable surgery. For more information on Operation Sight or National Sight Week, visit www.ascrsfoundation.org/nationalsightweek or contact Evelyn Morales at the ASCRS Foundation at emorales@ascrs.org or by phone at 703-591-2220.

Research briefs
  • Older adults with impaired vision are at an increased risk of perceived discrimination, reported Sarah Jackson, PhD, and coresearchers. Their study included information from 7,677 participants all age 50 or over who were part of the English Longitudinal Study of Ageing. Depressive symptoms, life satisfaction, quality and life, and loneliness were assessed. Participants also categorized their eyesight. The mean patient age was 66.7 years, and 52.4% were female. Those with self-rated poor eyesight had increased odds of reporting perceived discrimination compared with those who had good eyesight. Those who reported poor eyesight and discrimination had increased odds of depressive symptoms and loneliness as well as lower quality of life and life satisfaction when compared with those who had poor eyesight and no reported discrimination. Perceived discrimination was associated in the study with an increased risk of depressive symptoms among participants who reported poor eyesight at the 6-year follow-up. The study is published in JAMA Ophthalmology.
  • Corneal guttata was significantly associated with a poorer visual acuity and worse self-assessed visual function after cataract surgery, even if cataract surgery improved corrected distance visual acuity (CDVA) and self-assessed visual function, reported Andreas Viberg, MD, and coresearchers. The retrospective, cross-sectional, register-based study included 33,741 patients from 49 Swedish cataract surgery units. A logistic proportional odds regression was used to model the impact of corneal guttata on visual acuity and self-assessed visual function. Main outcome measures were postop CDVA and the Rasch person score calculated from completion of the Catquest-9SF questionnaire. The negative effect of corneal guttata was detected most prominently during the first 3 weeks after surgery and persisted at least 3 months postop. The study is published in the Journal of Cataract & Refractive Surgery.
  • Graft shift direction in Descemet membrane endothelial keratoplasty (DMEK), particularly an inferior graft shift, affected the postop graft detachment rate, according to Kentaro Yuda, MD, and fellow researchers. Their retrospective study used intraop video images to analyze the effect of graft shift direction in 50 eyes of 50 patients. Correlations were analyzed between graft shift direction and multiple parameters. The highest graft detachment rate occurred in those with an inferior graft shift compared with other positioning (superior, 0% and 5%; nasal, 0% and 20%; inferior, 16.7% and 55%; temporal, 16.7% and 45%; and any segment, 23.3% and 65% for graft shift-negative and graft shift-positive eyes, respectively). Researchers also noted a higher postop endothelial cell density reduction in eyes with an inferior graft shift. A lower endothelial cell density reduction occurred in eyes with a superior graft shift. Graft shift direction did not appear to affect postop best corrected visual acuity or central corneal thickness. The study appears in Cornea.
  • Among a cohort of predominantly Hispanic patients, significant IOP and medication reductions were maintained safely through 36 months after implantation of the iStent (Glaukos) during cataract surgery, reported Mark Gallardo and Richard Supnet. Their retrospective, consecutive case series evaluated IOP, medications, and safety through 36 months after iStent implantation and cataract surgery in patients with primary open-angle glaucoma. Eyes were divided into two subgroups classified by preop IOP and surgical goal: The Controlled Group had an IOP of 18 mm Hg or lower and used one or more medications with a goal of reducing medication use, while the Uncontrolled Group had an IOP of 18 mm Hg or higher and a maximum tolerated medication load, with a goal to reduce IOP. A total of 87 eyes (49 Controlled, 38 Uncontrolled) completed the study. In the Controlled Group, the mean medications were reduced by 77.3% (2.6 medications preop versus 0.6 at 36 months). In the Uncontrolled Group, the mean IOP decreased by 31.2% (19.4 mm Hg postop versus 13.4 mm Hg at 36 months), and 91.7% of eyes achieved an IOP of 18 mm Hg or less. No intraop complications were observed; there was a stable visual field and retinal nerve fiber layer at 36 months. The study appears in Clinical Ophthalmology.

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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