Lucentis granted DR indication
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U.S. regulators have approved Lucentis (ranibizumab, Genentech, South San Francisco) for an additional indication: treatment of diabetic retinopathy (DR) in people with diabetic macular edema.
Approval was based on results from 2 pivotal phase 3 studies (RIDE and RISE) and is the first ocular therapeutic to be approved for the DR indication.
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Ultrasound device granted CE mark
for surgery-naïve glaucoma
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The EyeOP1 (EyeTechCare, Rillieux-la-Pape, France) has been granted a CE mark extension to now include all patients living with uncontrolled glaucoma, irrespective of prior treatment. The device reduces intraocular pressure by using focused ultrasound technology, the company said.
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Dailies Total1 show lengthy lubricity, low silicon
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Two separate studies on Dailies Total1 (Alcon, Fort Worth, Texas) indicated after 16 hours of lens wear, the lenses were shown to have equivalent lubricity to eyes without worn lenses. The second study showed the lenses have the lowest concentration of silicon at the outermost lens surface (less than 1%), which may influence improved wettability over other lens materials, the company said in a press release.
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Lower-income Chinese students have better vision than wealthier peers
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In one of the largest population-based studies ever conducted on myopia in children, researchers have discovered that lower-income students in China have better vision than their middle-class counterparts, according to the American Academy of Ophthalmology, which published the results.
Data from the study indicated myopia is twice as prevalent in the middle-income province of Shaanxi compared to the poorer neighboring province of Gansu. With about half the 13 million visually impaired children living in China, the government collaborated with Stanford University to undertake several population-based studies on childhood myopia. In 2012, they examined vision in nearly 20,000 fourth- and fifth-grade students: 9,489 students in Shaanxi, a middle-income province, and 10,137 students in Gansu, the second poorest province in China.
The prevalence of clinically significant myopia in Shaanxi is almost 23% compared to Gansu, at 12.7%. Higher math scores were associated with increased myopia, regardless of geographic location, and myopia was less prevalent in males.
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RPB co-sponsors Vision Health Report
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Research to Prevent Blindness (RPB, New York) is co-sponsoring a major Institute of Medicine (IOM, Washington, D.C.) study titled "Public Health Approaches to Reduce Vision Impairment and Promote Eye Health." The report will be released in 2016, and "will provide data for evidence-based strategies to improve knowledge, access and utilization to eye care in order to combat the dramatically rising rates of eye diseases in the U.S.," RPB said in a news release.
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BlephEx launches certified lid hygienist program
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BlephEx (Lake Worth, Fla.) will offer concentrated courses at a variety of locations in the U.S. in conjunction with major ophthalmic meetings "to provide education and practical training in the use of BlephEx," according to a company news release.
BlephEx is "the first and only device to deliver microblepharoexfoliation (MBE), which removes excess oil, debris and inflammation-promoting biofilm, from the eyelid margins," the company said.
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GA treatment study now enrolling in Europe
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Spain's Institut de la Màcula i de la Retina (Barcelona) is the first European site to be actively recruiting patients in the first phase 3 trial on lampalizumab to treat and slow the progression of the geographic atrophy (GA) secondary to age-related macular degeneration, the hospital said in a news release.
The studies will also explore if people with a specific mutation in complement factor I may benefit more from lampalizumab treatment.
Studies Chroma (GX29176) and Spectri (GX29185) are identically designed, double-masked, randomized studies comparing 10 mg dose of lampalizumab administered every 4 or 6 weeks by intravitreal injection to sham injections. Approximately 936 patients will be enrolled in each study (188 biomarker-positive patients and 124 biomarker-negative patients each for the sham, lampalizumab q4w, and lampalizumab q6w treatment groups, in each study), the hospital said.
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RESEARCH BRIEFS
- In patients with dry eye symptoms, ADV2 was an effective and relatively well-tolerated artificial tear for first-line therapy and should be considered as a treatment option for dry eye, especially in those patients who would benefit from a lipid-based formulation in addition to lubrication, according to a study. Peter A. Simmons, PhD, and colleagues randomized 256 patients to receive 1 of 2 lipid-based tear formulations containing carboxymethylcellulose, glycerin, polysorbate 80, and emulsified lipid (ADV1 or ADV2) or an existing lipid-based tear formulation (DET), and instilled 1 to 2 drops per eye at least twice daily. All 3 groups showed improvement in symptoms, and the 2 lipid-based formulations were non-inferior to DET in reducing the severity of symptoms of dryness at 90 days. Of the 3 treatment groups, the ADV2 group had the greatest improvements in tear break-up time and OSDI. Treatment-related adverse events were reported in 13 patients (13.4%) receiving ADV1, 8 (8.4%) receiving ADV2, and 21 (21.9%) receiving DET. Four patients (4.1%) in the ADV1 group and 2 (2.1%) in the ADV2 group discontinued owing to an adverse event compared with 14 (14.6%) receiving DET. The study is published in Clinical Therapeutics.
- An interval objective improvement in capsulorhexis skill on a haptic-enabled cataract surgery simulator was associated with intervening operating room experience, according to Shameema Sikder, MD, and colleagues. They evaluated a haptic-based simulator, MicroVisTouch, as an assessment tool for capsulorhexis performance in cataract surgery in 78 ophthalmology residents at 2 sites: the Wilmer Eye Institute at Johns Hopkins Medical Center (Baltimore) and King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Four variables (circularity, accuracy, fluency, and overall) were tested by the simulator and graded on a 0-100 scale. Circularity (42%), accuracy (55%), and fluency (3%) were compiled to give an overall score. Capsulorhexis performance was retested in the original cohort 6 months after baseline assessment. Average scores in all measured metrics demonstrated statistically significant improvement (except for circularity, which trended toward improvement) after baseline assessment. A reduction in standard deviation and improvement in process capability indices over the 6-month period was also observed. The study is published in Clinical Ophthalmology.
- The Trulign toric IOL (Bausch + Lomb, Bridgewater, N.J.) was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision, according to Jay S. Pepose, MD, and colleagues. In their prospective, randomized, single-masked multicenter study, the Trulign toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the non-toric accommodating IOL (Crystalens, Bausch + Lomb) control group, the authors said. The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P<.001) and uncorrected distance visual acuity (P=.002) than the control group at the 120- to 180-day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. The study is published in the Journal of Cataract & Refractive Surgery.
NEW PRODUCT BRIEFS
- Rhein Medical (St. Petersburg, Fla.) introduced the Melki 3.5 mm marker (developed in coordination with Toufic S. Melki, MD), to be used in the OR during vitrectomy or in the office for intravitreal injections. The company has also introduced the Younger 360 degree capsule polisher, developed in conjunction with Jared R. Younger, MD, with an acknowledgment to John R. Shepherd, MD, to allow "quick and easy" polishing of both the anterior and posterior capsules with the single instrument.
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EyeWorld Weekly Update is edited by Stacy Majewicz 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: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Eric D. Donnenfeld, 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: ASCRSOpinions 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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