LENSAR granted CE mark for application upgrades
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European Union regulators have granted the CE mark for a suite of 5 new application technologies on the LENSAR Laser System, the Orlando, Fla.-based company said in a press release.
The LENSAR Laser System with Streamline application upgrades include: wireless integration with popular topographers, iris registration, cataract density imaging, customized fragmentation patterns, and arcuate incision planning.
LENSAR received U.S. approval for the same indications in April, and plans on launching the system in Europe this week.
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FDA gives nod to AMO's S4 IR Excimer Laser System
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The Food and Drug Administration (FDA) has granted regulatory approval to the Star S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System, the agency said in a news brief. Abbott Medical Optics (Abbott Park, Ill.) system "reduces or eliminates myopia and/or astigmatism," and the laser includes an eye tracker, the FDA noted. The iDesign System includes an aberrometer, a corneal topographer, and treatment planning software. The systems are intended for wavefront-guided LASIK for up to -11 D of myopia and up to -5 D of astigmatism.
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FDA approves intelli-Case for contact lens use
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NovaBay Pharmaceuticals (Emeryville, Calif.) has received 510(k) clearance from the Food and Drug Administration (FDA) for its intelli-Case with hydrogen peroxide solutions, the company said in a press release.
According to NovaBay, hydrogen peroxide is the gold standard for contact lens disinfection, but determining the right concentration can confound users. The intelli-Case "monitors the neutralization of hydrogen peroxide during the disinfection cycle with sophisticated microprocessor electronics embedded in the cap of what otherwise looks like a standard peroxide lens case," the company said, and alerts users with a flashing green light when lenses are safe to insert into the eye.
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InSite to file BromSite NDA, announces merger plans
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InSite Vision (Alameda, Calif.) plans to promptly file a New Drug Application (NDA) this week with the FDA for marketing approval of its drug candidate BromSite (low dose [0.075%] bromfenac ophthalmic solution formulated in DuraSite) to reduce postoperative inflammation and prevent pain following cataract surgery, the company said.
InSite also announced plans to merge with QLT (Vancouver, Canada) and will become a QLT subsidiary, the company said in a press release. The combined companies will continue to develop QLT091001, QLT's Orphan Drug and FDA Fast Track-designated retinoid product candidate for the treatment of inherited retinal diseases. The merged companies also expect to file a second NDA for InSite Vision's DexaSite for the treatment of blepharitis in 2016.
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Researchers identify 'night blindness' gene
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An international team of researchers has identified a gene that could be responsible for some cases of human night blindness, the University of Bristol said in a news release.
Recent clinical trials of gene therapy for Leber congenital amaurosis (LCA) have shown early promising results in treated patients, although their improvements in vision appear to be temporary. Similarly, stem cell transplantation in patients with a range of inherited and acquired retinal disorders is currently undergoing clinical trials.
The gene PRDM8 is linked to the early loss of night vision in animal models, the researchers found. Unlike typical genes that affect the function/survival of light-sensitive retinal cells, PRDM8 appears to influence the inner neural circuitry of the retina that connects the photoreceptors with the rest of the central nervous system. PRDM8 affects the survival of neurons within this retinal circuitry so that they are permanently lost. Consequently, signals from the photoreceptors are not processed correctly through the circuitry of the inner retina causing night blindness, meaning this gene may be a potential candidate for gene therapy.
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RESEARCH BRIEFS
- The rate of trabeculectomy-related complications does not appear to be associated with mitomycin-C use in the long term, according to a large, cohort study. J.A. Olayanju and colleagues retrospectively enrolled the residents of Olmsted County, Minn., who underwent a trabeculectomy from January 1, 1985, through December 31, 2010; data was analyzed through January 2014. In 334 patients, 460 eyes underwent trabeculectomy, with 159 eyes having complications. Early complications were defined as those occurring within 3 months of surgery; 100 eyes were in this category. The remaining 59 eyes had late complications; 10 eyes had both early and late complications. The 20-year cumulative chances of early, late, or any complications were 19.7%, 26.0%, and 45.0%, respectively. The association between the rate of complications and mitomycin-C dose used was P=0.77. Overall, 98 cases underwent further surgical procedures as a direct result of the complication. The study is published in JAMA Ophthalmology.
- Using a capsular tension ring (CTR) to help fixate a toric IOL is both a simple and safe procedure, according to O. Sagiv and D. Sachs. They presented a case of a highly myopic 74-year-old white man who underwent toric IOL and CTR implantation during cataract surgery. On postop day 1, the IOL had rotated 90 degrees from the designated position, with a consequent high amount of astigmatism. A second procedure was performed and because it was not possible to secure the toric IOL in the correct position, an additional in-the-bag CTR was inserted, with an immediate optimal outcome. The IOL remained stable up to the final follow-up examination. The study is published in the Journal of Cataract & Refractive Surgery.
- Loteprednol etabonate was effective in postoperative photorefractive keratectomy (PRK) management and was significantly less likely to produce elevations in IOP than was dexamethasone. O. Thanathanee and colleagues reported in the Journal of Ocular Pharmacology and Therapeutics on 32 patients who underwent PRK in a prospective, randomized, double-masked study to compare loteprednol etabonate 0.5%/tobramycin 0.3% (Group 1) with dexamethasone 0.1%/tobramycin 0.3% (Group 2) in terms of the epithelial healing time, postoperative visual acuity, corneal haziness score, and intraocular pressure (IOP) in postoperative treatment after PRK. The corneal epithelium was healed within 3 days in both groups; however, the epithelium was closed on the second day in 3 cases in Group 1 compared with 1 case in Group 2. There were no statistical differences in uncorrected visual acuity at 1 and 3 months, corneal haze scores, or number of patients with at least a 5 mm Hg increase in IOP.
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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 nonasthmatic people.
- 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®. |
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: 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: 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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