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Health Canada approves iStent inject, U.S. study enrollment completed
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Glaukos (Laguna Hills, Calif.) announced that Health Canada has approved its iStent inject Trabecular Micro-Bypass Stent for the reduction of intraocular pressure (IOP) in patients diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma. The device can be used in combination with cataract surgery in patients who require IOP reduction and/or would benefit from glaucoma medication reduction. iStent inject is also indicated as a standalone procedure for patients who continue to have elevated IOP despite prior treatment with glaucoma medications or conventional glaucoma surgery, Glaukos said.
The company has also completed patient enrollment in its Food and Drug Administration pivotal Investigational Device Exemption trial for the iStent inject.
The iStent inject prospective, randomized, multicenter clinical trial includes about 40 sites and 500 randomized subjects. Subjects in the trial are randomized to either iStent inject in combination with cataract surgery or cataract surgery alone. The study protocol calls for randomized subjects to be followed for 2 years, with a primary endpoint of a 20% or greater reduction in IOP from baseline. This study will serve as the foundation for the U.S. regulatory submission, Glaukos said.
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| Presbia close to completing patient enrollment in pivotal U.S. study |
| Presbia (Dublin) has almost completed patient enrollment of its Food and Drug Administration (FDA) pivotal study for the Presbia Flexivue Microlens. The final Premarket Approval module will be submitted to the FDA after 300 treated subjects complete the 24-month follow-up visit. Currently, 11 U.S. sites are enrolling patients. |
| Patient enrollment in EBI-005 phase 3 underway |
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The first patients in a phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis have been enrolled, developer Eleven Biotherapeutics (Cambridge, Mass.) said in a news release. EBI-005 is a novel, topically administered interleukin-1 receptor blocker in development as a protein therapeutic for inflammatory diseases at the surface of the eye.
Results from a phase 2 study showed statistically significant improvements in mean change from baseline in patient-reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.
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| Trace metals in blood and risk of glaucoma linked |
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Researchers from the University of California, San Francisco analyzed data from a representative sample of the South Korean population and found a lower blood manganese level and higher blood mercury level were associated with greater odds of a glaucoma diagnosis, JAMA Ophthalmology said in a news release.
According to the journal, blood or urine metallic element levels and information pertaining to ocular disease were available for 2,680 individuals (19 years and older) participating in the fourth Korea National Health and Nutrition Examination Survey between January 2008 and December 2009.
No association was found between blood lead or cadmium levels or urine arsenic levels and a diagnosis of glaucoma in the study population.
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| 'Landmark' study confirms benefit of supplement use in diabetics |
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A science-based nutritional supplement was investigated in the landmark Diabetes Visual Function Supplement Study (DiVFuSS), and found improvement in contrast sensitivity, color vision, and macular pigment optical density (MPOD), according to marketer ZeaVision (St. Louis). Color vision was most improved, by 42%, ZeaVision added.
Sixty-seven subjects participated in DiVFuSS, designed to determine if a novel, multi-component nutritional supplement could be of benefit to patients with type 1 and type 2 diabetes, the company said.
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RESEARCH BRIEFS
- The incidence of opaque bubble layer (OBL) during creation of a LASIK flap with the VisuMax 500 kHz femtosecond laser (Carl Zeiss Meditec, Jena, Germany) was 5.0%. A steep, thick cornea and a hard-docking technique could be risk factors for an OBL, according to H.G. Jung and colleagues. They retrospectively analyzed 827 myopic eyes that fell into 2 groups: OBL-occurrence group and OBL-free group. Clinical outcomes in the 2 groups were compared to measure the risk factors and clinical effects of an OBL. The mean flat keratometry was steeper and the preoperative cornea thicker in the OBL-occurrence group. The OBL-occurrence group had harder applanation (i.e., a larger area of meniscus) than the OBL-free group. The incidence of OBL was higher in the hard-docking technique. Clinical outcomes, including refractive error, visual acuity, and optical quality, in the 2 groups were not statistically significantly different 1 month after LASIK. The study is published in the Journal of Cataract & Refractive Surgery.
- At more than 1 year postoperatively, the absolute success rate of treating advanced glaucoma by endocyclophotocoagulation (ECP) and phacoemulsification was low, but did result in lower medication use, according to J. Morales and colleagues. They conducted a retrospective chart review on patients who underwent the combined procedure between 2005 and 2012. Absolute success was defined as IOP ≤15 mm Hg without medication and qualified success was IOP ≤15 mm Hg with medications. Mean IOP decreased from 17±1.4 mm Hg preoperatively in the 104 eyes (104 patients) to 14.7±1.3 mm Hg at the last postoperative visit. Absolute success was achieved in 11.9% and qualified success was achieved in 72.3%. Best corrected visual acuity improved by ≥2 lines in 76 (73%) eyes. Eyes with primary open-angle glaucoma had the higher absolute and qualified success rates compared with primary angle-closure and pseudoexfoliation glaucoma (P>0.05). Although 48 (46%) patients required more than 3 medications for IOP control, before surgery 78 patients (75%) needed at least 3 medications. The study is published in the Journal of Glaucoma.
- Cataract surgery results in intraocular pressure (IOP) reduction in eyes with either open angles (OA) or narrow angles (NA), according to a study. S. Moghimi and colleagues prospectively enrolled 85 non-glaucomatous eyes (39 with OA, 46 with NA). The average IOP reduction was -4.95±2.26mm Hg, from a preoperative mean of 17.12±2.47mm Hg, at 3 months after cataract surgery. The amount of IOP reduction was significantly greater in the NA compared with the OA group. In multivariate linear regression analysis, preoperative IOP and anterior vault were significantly associated with IOP decrease (all P≤0.03). The study is published in Eye.
NEW PRODUCT BRIEFS
- Bausch + Lomb (Bridgewater, N.J.) launched a 23-gauge fragmentation needle for the Stellaris PC Vision Enhancement System, the company said. This new ultrasonic needle design is used during vitreoretinal procedures to effectively remove the lens material from the posterior chamber of the eye with balanced irrigation and aspiration through 23-gauge incisions.
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Important Safety Information about PROLENSA®
- PROLENSA® contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmaticpeople.
- All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
- There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs.
- There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
- Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
- Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
- PROLENSA® should not be instilled while wearing contact lenses. The preservative in PROLENSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA®.
- The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.
Click here for Prescribing Information about PROLENSA®.
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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
For sponsorship opportunities or membership information, contact: ASCRS*ASOA * 4000 Legato Rd. * Suite 700 * Fairfax, VA 22033 * Phone: 703-591-2220 * Fax: 703-591-0614 * Email: ASCRS
Opinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS*ASOA. Mention of products or services does not constitute an endorsement by ASCRS*ASOA. |
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