EW Weekly, January 8, 2016

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January 8, 2016
Volume 21 , Number 1

CLS-TA produces encouraging topline results in non-infectious uveitis study

The use of CLS-TA resulted in a statistically significant mean change from baseline in central subfield thickness at 8 weeks after one single treatment (P=.0018) in the treatment of macular edema associated with non-infectious uveitis, developer Clearside Biomedical (Alpharetta, Ga.) said in a press release. Topline results on the Dogwood trial evaluated the safety and efficacy of CLS-TA (a proprietary form of triamcinolone acetonide delivered through the suprachoroidal space) in 22 patients with macular edema associated with non-infectious uveitis.
Statistical significance was also achieved in the mean increase from baseline in best corrected visual acuity (P=0.0004), a secondary endpoint. There were no treatment-related serious adverse events reported in the trial, including no reported steroid-related increases in intraocular pressure (IOP), which is common in intravitreal and periocular drug delivery of corticosteroids.
The Dogwood trial was the first masked, randomized clinical trial conducted in which drug was administered through the suprachoroidal space. This U.S., multicenter trial randomly assigned patients in a 4:1 ratio to receive a single injection of CLS-TA, 4 mg/100 µL or CLS-TA, 0.8 mg/100 µL. Subjects were treated at day 1 and were monitored for safety and efficacy for 8 weeks following their injection.

Luminate phase 2b DME study completes enrollment

The Del Mar phase 2b trial evaluating the safety and efficacy of Luminate (ALG-1001, a first-in-class integrin peptide therapy) in patients with diabetic macular edema (DME) has completed patient enrollment, developer Allegro Ophthalmics (San Juan Capistrano, Calif.) said in a news release.
Del Mar is a double-masked, placebo-controlled, randomized, multicenter, 6-month trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate compared to the current standard of care for patients with DME. The trial enrolled 120 patients who were randomized to 1 of 4 treatment groups that included 3 Luminate groups (1.0 mg, 2.0 mg, or 3.0 mg) and a bevacizumab group. The trial is being conducted in approximately 40 sites across the U.S. Topline results are expected by the third quarter.

IOPtimate gains Canadian approval

The IOPtimate system for the treatment of glaucoma has been approved by the Canadian Medical Devices Bureau, said developer BioLight Israeli Life Sciences (Tel Aviv, Israel).
The IOPtimate surgical system enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 laser-assisted sclerotomy surgery) to reduce elevated intraocular pressure. CLASS is automated "and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available," BioLight said.
The IOPtimate surgical system enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 laser-assisted sclerotomy surgery) to reduce elevated intraocular pressure. CLASS is automated "and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available," BioLight said.

IRIS II Vision Restoration System to undergo studies in France

Pixium Vision (Paris) received approval from French Regulatory Authority to implant its IRIS II Vision Restoration System in patients with retinitis pigmentosa. Subject to CE mark approval, the device will begin studies in the first half of 2016.
The IRIS II is an epiretinal implant with 150 electrodes, designed to be explanted and upgraded when necessary, that function as a "bionic vision system," Pixium said. The system uses a smart bio-inspired camera that functions like the human eye.

Medidur meets primary endpoint in posterior uveitis phase 3 study

A sustained release of 0.18 mg of the corticosteroid fluocinolone acetonide (Medidur, pSivida, Watertown, Mass.) was highly statistically significant in meeting its primary efficacy endpoint of prevention of recurrence of chronic posterior uveitis at 6 months (P<0.00000001; intent to treat analysis) in a phase 3 study. The 129-patient, multicenter, randomized, double-masked study also showed positive safety results. There were about 11% more Medidur-treated eyes than control eyes that experienced an increase in intraocular pressure (IOP) above 21 mm Hg through 6 months, which was reduced to 6.1% through the most recent follow-up visits (some as long as 24 months). A total of 87 eyes were treated with Medidur; 42 eyes served as controls and received sham injections. Among the results: 18.4% of Medidur-treated eyes had a recurrence, compared to 78.6% of the control eyes, and 23% of the Medidur-treated eyes had a 3-line gain in visual acuity (compared to 5% of control eyes).

Awards and appointments

  • Mark Humayun, MD, will be awarded the National Medal of Technology, presented by President Barack Obama. The award represents the nation's highest for a technology achievement. Dr. Humayun is being honored for his work on bio-implants to restore vision, including the Argus II retinal prosthesis system.
  • Joel S. Schuman, MD, has been named chair of the Department of Ophthalmology at NYU Langone Medical Center, the center said. Among Dr. Shuman's accomplishments is being a part of the group to first discover a molecular marker for glaucoma.

RESEARCH BRIEFS

  • An injectable intraocular miniature telescope appears safe in the short- to medium-term and capable of improving visual function in patients with bilateral, intermediate, or advanced dry age-related macular degeneration (AMD), according to Muhammad A. Qureshi, FRCS(Ophth), and colleagues. In this pilot study, eyes had implantation of 2 IOLs designed for use together in a Galilean telescope configuration (iolAMD). There were no significant intraoperative or postoperative complications. In 1 eye, an anterior sulcus IOL was replaced; there were no sequelae. The mean endothelial cell density was reduced by 18%. The mean decimal CDVA improved from 0.12 preoperatively to 0.20 at 4 months, a 67% gain. The mean change in spherical equivalent after implantation was −1.5 D with 0.5 D of induced astigmatism. Microperimetric testing indicated a magnification effect and a deviation of the retinal image by up to 5 degrees, with improved fixation stability. The study is published in the Journal of Cataract & Refractive Surgery.
  • Micro-organisms can be isolated from calcified plaques developed at the site of previous pterygium excision, and the size of plaques is the only risk factor for culture-positive results, according to T.J. Kim and colleagues. Only exposed calcified plaques developed at the same site of previous pterygium excision were prospectively removed in 15 eyes of 14 patients. Plaques were completely removed, divided into small pieces and evaluated for microbiological identification. At surgery, the mean age of the patients was 71.2±5.8 years and 71.4% were females. The mean time interval between pterygium excision and calcified plaque removal was 19.3±13.8 years. Six of 15 (40%) removed plaques showed bacterial growth, and Stenotrophomonas maltophilia was the most frequently isolated micro-organism. The size of calcified plaques was the only risk factor for culture-positive results (P=0.045). Underlying scleral defects were successfully repaired without any serious complication. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • The Esclera scleral contact lens (SCL) treatment had a positive impact on tear osmolarity and van Bijsterveld score, as well as an improvement in patients' best corrected visual acuity, dry eye disease (DED) symptoms, and quality of life. S. La Porta Weber and colleagues evaluated 41 eyes from 25 patients with moderate to severe DED for Esclera SCL treatment. Forty-one eyes from 25 patients were fitted with the SCL for management of DED. The underlying diseases were Stevens Johnson syndrome (22 eyes), Sjögren's syndrome (11 eyes), Graft-versus-host disease (2 eyes), dry eye after keratomileusis in situ (2 eyes), and undifferentiated ocular surface disease (4 eyes). BCVA improved from 0.703±0.55 logMAR with habitual correction to 0.406±0.43 logMAR with SCL (p<0.001). There was a significant decrease in tear osmolarity values (338.1±27.1 to 314.25±38.8 mOsm/L, p<0.001) and van Bijsterveld scores (3.63±2.33 to 2.63±2.46 grade, p=0.015) between the baseline and 12 months after SCL wear. The study is published online ahead of print in American Journal of Ophthalmology.

NEW PRODUCT BRIEF

  • Nidek (Gamagori, Japan) launched the VersaCam alpha digital medical scope. The VersaCam alpha features a 5-megapixel clear-color camera with a 45-degree horizontal angle of view (40-degree vertical) for high-quality digital imaging. Weighing in at 445 g, it is designed to be portable with up to 3 hours of continuous operation.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, 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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