EW Weekly, February 28, 2020

Final patient enrolled in Elate Ocular Phase 1/2 study for dry eye; Orphan Drug Designation given
The final patient has been enrolled in a Phase 1/2 study for Elate Ocular (Cambium Medical Technologies) topical fibrinogen-depleted human platelet lysate biologic. The randomized, multicenter, double-masked, placebo-controlled trial will help determine safety and exploratory efficacy in 66 patients with dry eye secondary to graft-versus-host disease, according to a company news release. Final outcomes are expected in the second quarter of this year. Cambium leaders also announced this week that the U.S. FDA has granted an Orphan Drug Designation for Elate Ocular to treat ocular graft-versus-host disease.

Study: IOL rotation may help lower the risk of postop pseudophakic negative dysphotopsia
Rotating the IOL to orient the optic-haptic junctions at 180 degrees may be a safe, effective way to lower the risk of postop pseudophakic negative dysphotopsia in the first month after surgery, reported GSL Nanasseh and coresearchers. Their single-center, prospective, double-masked, randomized controlled trial included 220 eyes from 201 participants and focused on whether horizonal orientation of the IOL optic-haptic junctions affected the incidence of pseudophakic negative dysphotopsia. All participants were having routine cataract surgery and were randomized to receive their IOL oriented with the optic-haptic junctions at 180 degrees (horizontal) or without manipulation after implantation (control). At postop week 4, a phone interview was completed to determine rates of negative dysphotopsia. By orienting the IOL optic-haptic junctions horizontally, the incidence of pseudophakic negative dysphotopsia was cut in half by postop week 4 (P=0.072). The overall negative dysphotopsia incidence was 12.2%. There were no adverse effects associated with IOL rotation. This study is the first to show the benefit of horizontal optic-haptic junction positioning to be maintained beyond the first postop day, according to the authors. The study appears in Acta Ophthalmologica.

LumiThera to broaden research into diabetic retinopathy
LumiThera has begun studies at the University of Wisconsin-Milwaukee for the use of its photobiomodulation platform in diabetic retinopathy, according to a company news release. Its photobiomodulation treatment called the Valeda Light Delivery System is already used with other ocular disorders and diseases, including dry age-related macular degeneration (AMD). The company received a CE mark to commercialize the Valeda Light Delivery System in the European Union to treat ocular diseases, including dry AMD. The company also has received a $2.5 million grant from the National Institutes of Health and the National Eye Institute to support its multicenter LIGHTSITE II clinical trial for dry AMD. Company leaders are currently enrolling for two trials, one in the European Union and one in the U.S.

Long-term data announced in Phase 1/2a trial of hRPC stem cell therapy for retinitis pigmentosa
A meaningful clinical effect was found from therapy at any time out to 12 months after treatment with an hRPC stem cell therapy candidate in retinitis pigmentosa, according to a news release from the ReNeuron Group. Their findings are part of a Phase 1/2a clinical trial. Previous results announced in October also indicated sustained and clinically relevant visual acuity improvements compared with baseline, according to the company. A protocol amendment has been filed with the U.S. FDA to expand the study and treat up to nine more patients with a dose of 2 million hRPC cells. Until now, the dosage used has been 1 million cells. ReNeuron’s program in retinitis pigmentosa has been give an Orphan Drug Designation in both Europe and the U.S. and a Fast Track Designation in the U.S.

Registration open for Eyecelerator
Registration is now open for Eyecelerator, a next-generation business conference to further ophthalmic innovation. The conference is a joint venture between the American Academy of Ophthalmology (AAO) and ASCRS. The inaugural Eyecelerator conference will be held on May 14 in Boston, in conjunction with the ASCRS Annual Meeting. The second Eyecelerator conference will be in November, in conjunction with the AAO Annual Meeting in Las Vegas. The conference will showcase emerging technology, groundbreaking research, and inventive concepts. For more information, visit eyecelerator.com.

Research briefs
  • The use of Scheimpflug tomography pachymetry map and posterior elevation map patterns were able to predict Fuchs endothelial corneal dystrophy prognosis independent of central corneal thickness (CCT), according to Sanjay Patel, MD, and coresearchers. Their cross-sectional study included 96 eyes from 56 subjects who had a range of Fuchs severity. Their corneas were graded by specialists according to the area and confluence of guttae and whether clinically definite edema was present. One observer assessed masked and randomized Scheimpflug imaging pachymetry map and posterior elevation map patterns for various factors, such as the loss of regular isopachs and displacement of the thinnest point of the cornea. Over a 5-year median period, prognosis was determined based on Fuchs progression (new onset of clinically definite edema or a 5% or more increase in CCT) or the need for endothelial keratoplasty. The loss of regular isopachs, displacement of the thinnest point, focal posterior surface depression, and anterior corneal backscatter were risk factors for progression or intervention, but CCT was not. The risk for Fuchs progression and intervention increased over time according to the number of parameters present. The research is published in Ophthalmology.
  • In a prospective study analyzing waste from phaco in Malaysia, the average waste per case was 0.827 kg, reported Hui Gim Khor, MD, and coresearchers. When excluding the recyclable material, the mean waste per case was 0.669 kg. Researchers divided waste into general waste, clinical waste, and sharps. A total of 203 cases was considered, which in total generated 167.965 kg of waste. Of that, 56.6% was clinical waste, 37.6% was general waste, and 5.8% was sharps. Among the general waste, 50.9% was recyclable waste products. The mean waste production per case was 0.814 kg for an ophthalmologist and 1.086 kg for a trainee. The environmental impact might be reduced more by following the 3 Rs—reduce, reuse, and recycle, according to the researchers. The study appears in the Journal of Cataract & Refractive Surgery.
  • The screening capabilities of spectral-domain OCT (Cirrus SD-OCT, Carl Zeiss Meditec), scanning laser polarimetry (GDx), and Heidelberg Retina Tomograph (HRT, Heidelberg Engineering) were similar, but the accuracy of the evaluated parameters was only moderate, according to Katri Stoor and coresearchers. Study participants in the Northern Finland Birth Cohort Eye Study had a comprehensive eye examination including modern imaging with retinal nerve fiber layer (RNFL) and macular ganglion cell layer and inner plexiform layer analysis as well as the combination of SD-OCT, GDx, and HRT. Performance of the devices was analyzed using a clinical glaucoma diagnosis and a “2 out of 3” rule based on optic nerve head evaluation and RNFL photos and visual fields. A total of 6,060 eyes of 3,039 subjects were evaluated. Glaucomatous damage was found in 1.1% of eyes. Sensitivities were 53%, 50%, 61%, 56%, and 31% with the RNFL analysis, macular ganglion cell layer and inner plexiform layer analysis, OCT combination analysis, GDx, and HRT. The corresponding specificities were 95%, 92%, 90%, 80%, and 96%. Screening with these parameters alone is not reliable enough, the researchers concluded. The study is published in the British Journal of 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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