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August 7, 2015
Volume 20, Number 30

Victus gets 510(k) OK for 'enhanced patient interface'

The Food and Drug Administration has granted 510(k) clearance to Bausch + Lomb (Bridgewater, N.J.) for an enhanced patient interface kit for the Victus femtosecond laser platform, the company announced.

The interface features a smaller diameter suction clip, which has been modified to allow for easier opening and closing of the clip "to help facilitate more efficient placement of the clip in patients with narrow fissures and smaller eye openings," the news release said. Additional features include a colored suction skirt and a multi-port suction design.

The Victus is already approved for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery.
Omidria receives EC approval

The European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1%/0.3% in the European Union for use in cataract surgery and lens replacement procedures to maintain mydriasis, prevent miosis, and to reduce postoperative eye pain, developer Omeros (Seattle) said in a news release.

The European approval was based on the same clinical data that formed the Food and Drug Administration's U.S. approval last year. Decisions about price and reimbursement for Omidria will occur on a country-by-country basis.
iStent inject granted Australian approval

The Australian Therapeutic Goods Administration (TGA) has granted approval for the iStent inject Trabecular Micro-Bypass Stent to its developer, Glaukos (Laguna Hills, Calif.). With TGA approval, the iStent inject is now indicated for use in Australia in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate glaucoma currently treated with ocular hypotensive medication.

The iStent inject allows an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point for greater IOP reduction, Glaukos said. Each iStent inject is about 0.3 mm x 0.4 mm, or roughly one-third the size of the original iStent.
Shire buys Foresight; gains all rights to FST-100
Shire (Lexington, Mass.) has bought Foresight Biotherapeutics (New York) for $300 million, including global rights to FST-100 (topical ophthalmic drops combining 0.6% povidone iodine and 0.1% dexamethasone), a therapy in late-stage development for the treatment of infectious conjunctivitis.
Glaucoma medication may treat TB

Michigan State University (MSU) scientists have reason to believe ethoxzolamide, a sulfa-based compound found in many prescription glaucoma drugs, could also be used to treat tuberculosis (TB), even the drug-resistant kind, the university said.

According to Robert Abramovitch, PhD, TB "may not have eyes and ears, but it has the uncanny ability to sense certain environmental cues in the body and adapt. One of these cues includes the infection's ability to detect pH, or acidity levels, which tells the disease it's being attacked by a host immune cell," MSU said in a news release.

Ethoxzolamide "inhibits TB's ability to detect acidic environments, effectively blindfolding the bacterium so it can't resist the immune system's assault," Dr. Abramovitch said.
Aerie moves ahead with wet AMD compound

Aerie Pharmaceuticals (Irvine, Calif.) said its pre-clinical in vivo studies on the AR-13154 molecule found it reduced wet age-related macular degeneration lesion size more than aflibercept. AR-13154 targets Rho kinase, Janus kinase 2, and platelet-derived growth factor receptor beta, the company said.

As a result, Aerie is moving into clinical development with AR-13154 using GrayBug's (Baltimore) polymer-based delivery technology to provide multi-month drug release capability. GrayBug is a spin-out of the Wilmer Eye Institute of the Johns Hopkins University School of Medicine.

Aerie is also using Graybug's delivery technology to evaluate long-term sustained delivery of the active ingredient in its glaucoma compound Rhopressa.

RESEARCH BRIEFS

  • Axial length measurements using a biometer based on optical low coherence reflectometry (OLCR) appeared as reliable as those made using the standard measurement mode, according to H.J. Shammus and colleagues. In this cross-sectional, retrospective study, data were collected from 2 sites where the "dense cataract measurement" mode for the OLCR on the LENSTAR LS900 (Haag-Streit, Koniz, Switzerland) had been used. The percentage of eyes that were measurable in the new mode that were not measurable in the standard mode was calculated. Data for 4,791 eyes were available for analysis. Axial length (AL) measurement was possible using the standard algorithm in 94.4% of cases. The use of the new mode allowed for measurement of an additional 4.0% of cases, a statistically significant increase (P<.001). Comparisons of AL measurements with concurrent ultrasound or postoperative optical biometry showed high correlations, with the 95% limits of agreement of -0.47 to +0.29 mm, similar to results for standard measurements. The study is published in the Journal of Cataract & Refractive Surgery.
  • Topical azithromycin suppressed expression of pro-inflammatory mediators and increased expression of transforming growth factor β1 (TGF-β1) to normal levels, according to a study in JAMA Ophthalmology. L. Zhang and colleagues performed a case-controlled study where 16 patients with posterior blepharitis and conjunctival inflammation due to MGD were treated with azithromycin, 1%, drops for 4 weeks. Compared with a 1-time measurement of 8 healthy participants, among 16 symptomatic patients, the mean fold change of expression of pro-inflammatory mediators interleukin 1β (IL-1β), IL-8, and MMP-9 increased to 13.26, 9.38, and 13.49, respectively (all P<.001), in conjunctival cells and to 11.75, 9.31, and 11.52 (all P<.001), respectively, in the eyelid margin of patients with MGD. In contrast, the mean fold change of expression of TGF-β1 messenger RNA (mRNA) decreased to 0.58 and 0.63 (both P=.02) in conjunctival and eyelid margin cells, respectively, of patients with MGD. Levels of IL-1β, IL-8, and MMP-9 mRNA remained suppressed, although they rebounded toward pretreatment values 4 weeks after azithromycin withdrawal. Expression of TGF-β1 increased during treatment and remained at levels similar to the healthy controls after drug withdrawal.
  • Eyes with glaucoma are at increased risk for complications and have more modest visual outcomes after cataract surgery compared to eyes without glaucoma, according to a large cohort study. Angela Turalba and colleagues identified 608 glaucoma cases and 4,306 controls undergoing planned cataract surgery alone from the Veterans Affairs Ophthalmic Surgery Outcomes Data Project. After adjusting for age, pseudoexfoliation, small pupil, prior ocular surgery, and anterior chamber depth, they found glaucoma cases were more likely to have posterior capsular tear with vitrectomy (odds ratio [OR] 1.8, P=.03) and sulcus IOL placement (OR 1.65, P=.03) during cataract surgery. Glaucoma cases were more likely to have postoperative inflammation (OR 1.73, P<.0001), prolonged elevated intraocular pressure (OR 2.96, P=.0003), and additional surgery within 30 days (OR 1.92, P=.03). Mean best corrected visual acuity (BCVA) and Visual Function Questionnaire (VFQ) scores significantly improved after cataract surgery in both groups (P<.0001), but there were larger improvements in BCVA (P=.01) and VFQ composite scores (P<.0001) in the non-glaucoma versus the glaucoma group. 3,621 (94.1%) non-glaucoma cases had postoperative BCVA of 20/40 or better, compared to 466 (89.6%) glaucoma cases (P=.0003). The study is published in the American Journal of Ophthalmology.




EyeWorld Weekly Update is edited by Stacy Jablonski and Michelle Dalton.

 

EyeWorld Weekly Update (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 D. Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Steven C. Schallhorn, MD, refractive editor; and John A. Vukich, MD, international editor

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