EW Weekly, September 6, 2019

Topline pivotal data for DE-128 MicroShunt includes IOP and medication use reductions
Use of the DE-128 MicroShunt (Santen) in patients with primary open angle glaucoma (POAG) was associated with IOP reductions and a decrease in medication use, according to topline pivotal data released by the company. The results come from INN-005, a prospective, randomized, controlled, single-masked multicenter study to assess the safety and effectiveness of DE-128 as a standalone, without cataract extraction. Intraop implantation of the DE-128 with 0.2 mg/ml concentration of mitomycin-C (MMC) was compared to trabeculectomy with the same concentration of MMC. The mean diurnal IOP at month 12 in the DE-128 group dropped from medicated 21.1 mm Hg to 14.2 mm Hg, compared with 21.1 mm Hg to 11.2 mm Hg in the trabeculectomy arm. The mean number of glaucoma medications used per patient decreased in both groups, from 3 medications at screening to 0.6 in the DE-128 group and 0.3 in the trabeculectomy group at month 12. By month 12, 71.6% of subjects in the DE-128 group were medication-free compared with 84.8% in the trabeculectomy arm. Suture lysis was needed in 52.3% of patients in the trabeculectomy arm to lower IOP compared with no patients in the DE-128 group. The most common adverse event in both groups was increased IOP that needed additional treatment. Santen plans to complete a Modular PMA submission to the U.S. FDA, according to a company press release. DE-128 is already available in Europe.

REGENXBIO, Clearside Biomedical enter option and license agreement for RGX-314
REGENXBIO and Clearside Biomedical announced an option and license agreement for exclusive worldwide rights to the in-office SCS Microinjector (Clearside Biomedical) to deliver RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (AMD), diabetic retinopathy, and other conditions that use anti-vascular endothelial growth factor (VEGF) treatments. REGENXBIO plans to evaluate RGX-314 using the SCS Microinjector for in-office, nonsurgical delivery while continuing to advance its RGX-314 subretinal delivery program, according to a press release. RGX-314 is under development as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions treated with anti-VEGF. It contains the NAV AAV8 vector encoding an antibody fragment that inhibits VEGF, changing the pathway for formation of new leaky blood vessels. 

Large study finds intracameral moxifloxacin prophylaxis reduces endophthalmitis
In a study of 2 million consecutive cataract surgeries, intracameral moxifloxacin prophylaxis lowered the overall postop endophthalmitis rate with phaco, manual small-incision cataract surgery (M-SICS), and in eyes with posterior capsule rupture (PCR), reported Haripriya Aravind, MD, and coresearchers. Their retrospective multicenter clinical registry focused on more than 2 million cataract surgeries performed among 10 regional Aravind Eye Hospitals in India over an 8-year period. The overall postop endophthalmitis rate with intracameral moxifloxacin lowered from 0.07% to 0.02%, which was independently significant for phaco and M-SICS. The overall PCR rate was 1.37%, which was statistically higher for trainees with the use of any surgical method. There were higher PCR rates with phaco than with M-SICS. The study results are published in the Journal of Cataract & Refractive Surgery.

Research briefs
  • Primary selective laser trabeculoplasty (SLT) had comparable early absolute IOP-lowering in ocular hypertension (OHT) compared with OAG eyes, reported Anurag Garg, FRCOphth, and coresearchers, in their post-hoc analysis of a multicenter, prospective, randomized controlled trial. All patients were treatment-naïve and were randomized to SLT or topical medication and treated to predefined target IOPs that required a 20% or greater IOP decline from baseline for all disease severity levels. A total of 611 eyes (195 OHT and 416 OAG) of 355 patients received SLT, while 622 eyes (185 OHT and 437 OAG) of 362 patients received topical medication at baseline. There was no difference in early absolute IOP-lowering after SLT between OHT and OAG eyes. There also was no difference in early absolute IOP-lowering between topical medication and primary SLT. Nearly 75% of eyes treated with primary SLT had drop-free disease control at 36 months, most of which occurred after a single SLT. The total SLT power and 2-month IOP were predictors of drop-free disease control at 36 months after single SLT. The study is published in Ophthalmology.
  • Causes of IOL removal for a case series of patients seen by a retinal surgery practice included IOL opacification, oil artifact, opaque nonvascular membranes, and fibrovascular proliferation, reported Nimesh Patel, MD, and coresearchers. Their retrospective, interventional case series focused on IOL removal at an academic referral center performed by a single surgeon between 2002 and 2013. A total of 63 eyes were included, 81% of which were left aphakic. For cases of IOL opacification or a dislocated IOL, the decision to remove the IOL was made in 63% of patients during concurrent retinal surgery due to obstruction in visualization. Other reasons for IOL removal included dislocation, endophthalmitis, and a broken IOL haptic. The mean immediate, 3-month, and final best corrected visual acuity were 2.18 logMAR, 1.85, and 1.97, respectively. The study appears in Ophthalmic Surgery, Lasers & Imaging Retina.
  • Patients with active neovascular AMD in one eye appear to have a high risk for fellow eye conversion and should be monitored closely, concluded Ravi Parikh, MD, and fellow researchers. They performed a post-hoc analysis of the VIEW 1 and VIEW 2 studies, both of which compared the efficacy and safety of intravitreal aflibercept in 2,457 patients with treatment-naïve eyes who had wet AMD. All participants were included in one of four groups with different treatment plans for aflibercept or ranibizumab. Among the 1,561 participants, at 96 weeks, 24% of patients experienced cases of conversion to neovascular disease in the fellow eye. Increasing patient age (per 10 years) at baseline, female sex, and increasing choroidal neovascularization lesion size in the study eye at baseline were associated with fellow eye conversion. Fellow eye conversion rates were similar with either of the treatments. The study appears in JAMA 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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