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FDA accepts Raindrop submission
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The Food and Drug Administration (FDA) has accepted a premarket approval (PMA) submission for the Raindrop Near Vision Inlay, developer ReVision Optics (Lake Forest, Calif.) said in a press release. The Raindrop is a microscopic hydrogel inlay designed to correct presbyopia. FDA's acceptance of the PMA starts a 180-day period where the FDA will review the submission before determining if an advisory panel needs to be convened before ruling on the submission. That should occur during the first quarter of 2016, ReVision Optics said.
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IOP reduction holds through year 3 with dual iStents, study finds
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A new study has found two iStent trabecular micro-bypass stents provided "statistically significant, sustained and safe reduction in intraocular pressure (IOP) to about 15 mm Hg without medication through 36 months" in patients with open-angle glaucoma, developer Glaukos (Laguna Hills, Calif.) said in a press release.
In this prospective pilot study conducted by multiple surgeons at a single investigational site, 39 phakic and pseudophakic subjects with open-angle glaucoma and preoperative unmedicated IOP between 22 mm Hg and 38 mm Hg received two stents in a standalone procedure. At 36 months, subjects not taking medication achieved mean IOP of 15.2 mm Hg, representing a 37% reduction from unmedicated baseline IOP. In four subjects who required medication, IOP ranged from 13 mm Hg to 15.7 mm Hg at 36 months. There were no postoperative adverse events related to stent implantation, except for one incidence of early postoperative hyphema that resolved at 1 week.
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Genentech launches sustained release Lucentis study
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Genentech (South San Francisco) has initiated a phase 2 clinical trial evaluating the ranibizumab port delivery system in patients with neovascular age-related macular degeneration, the company said. LADDER (Long Acting DElivery of Ranibizumab) will assess the efficacy and safety of the implant for the sustained delivery of Lucentis (ranibizumab) for the treatment of wet AMD.
A previous phase 1 study showed the implant to be well tolerated and showed an improvement in best corrected visual acuity comparable to monthly injections, Genentech said. The implant also recently received Fast Track designation from the Food and Drug Administration.
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Movement disorder drug may prevent AMD
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A drug already used safely to treat Parkinson's disease, restless leg syndrome and other movement disorders also could delay or prevent the most common cause of blindness affecting more than 9 million older Americans, age-related macular degeneration (AMD).
Researchers have discovered that patients who take the drug L-DOPA are significantly less likely to develop AMD, and if they do develop AMD it's at a significantly older age, according to researchers at Marshfield Clinic Research Foundation, University of Arizona, Medical College of Wisconsin, University of Miami, Essentia Health, Stanford University and University of Southern California.
L-DOPA is a natural byproduct of pigmentation; if patients no longer produce L-DOPA and are supplemented through pill form, it may have the potential to serve as a preventive medicine against AMD, the researchers said. Initial studies were conducted in albino mouse models, and led to the current theory that darker pigmentation may be protective.
To test this, researchers examined health records of 37,000 Marshfield Clinic patients looking for those with AMD, those taking L-DOPA and those with both L-DOPA and AMD. They then determined the age patients developed AMD.
According to national statistics, the average age at which individuals are given L-DOPA is 67; the average age of AMD diagnosis is 71. In those people who received L-DOPA before being diagnosed with AMD, their AMD diagnosis occurred 8 years later than those without L-DOPA.
These provocative results were then confirmed in a much larger data set of 87 million patients where similar results were observed, and the study expanded to include prevention and delay of wet AMD, the most devastating form of the disease.
In all the groups examined, data suggests L-DOPA may prevent or delay AMD.
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RESEARCH BRIEFS
- Recovery of central corneal sensitivity to baseline was reached by 6 months after small-incision lenticule extraction and was higher than after LASIK for the first 6 months after surgery, according to new research. Dan Z. Reinstein, MD, and colleagues retrospectively evaluated consecutive myopic eyes that were treated with small-incision lenticule extraction using the VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany). Corneal sensitivity was measured centrally and at 4 paracentral locations using a Cochet-Bonnet esthesiometer preoperatively and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. Results were compared with averaged results from previous LASIK and small-incision lenticule extraction studies. After small-incision lenticule extraction, the preoperative mean central corneal sensitivity dropped from 54 mm preoperatively to 33 mm 1 day postoperatively, rising to 40 mm, 45 mm, 48 mm, 54 mm, and 55 mm over 12 months; it reached baseline at 6 months (P>.05). For 21 LASIK studies, the mean central corneal sensitivity dropped from 56 mm preoperatively to 6 mm at 1 day, rising to 14 mm, 23 mm, 34 mm, 45 mm, and 51 mm over 12 months. For 8 small-incision lenticule extraction studies, central corneal sensitivity dropped from 57 mm preoperatively to 39 mm at 1 week, then rose to 39 mm, 42 mm, 49 mm, 52 mm, and 54 mm over 12 months; it was higher than after LASIK at 1 week and 1, 3, and 6 months (P<.05). The study is published in the Journal of Cataract & Refractive Surgery.
- Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia, according to M. Labetoulle and colleagues. Further, they say patients who received intracameral Mydrane were significantly more comfortable before IOL insertion than the reference group. In this international phase 3, prospective, randomized study, the selected eye of 555 patients undergoing phacoemulsification with IOL implantation received 200μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as "routine" in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups. The study is published in the British Journal of Ophthalmology.
- Non-central keratoconus has lesser effect on SimK, pachymetry and smaller-aperture higher-order aberrations root mean square (HOARMS), according to G. Prakash and colleagues. They evaluated the differences in central and non-central keratoconus (based on cone location). Apex keratometry (ApexK), simulated keratometry at 3 mm (SimK), central corneal thickness (CCT) and minimum corneal thickness (MCT), anterior corneal HOARMS, and Zernike's coefficients up to fourth order at different zones were measured. In spite of the keratoconic groups having comparable ApexK (p>0.05), central keratoconus had higher SimK and thinner CCT and MCT (p<0.001). HOARMS was significantly more for central keratoconus at 3 mm zones. These findings had moderate to large effect size. Receiver operating curve analysis was carried out to compare central keratoconus and non-central keratoconus with the control group. ApexK and HOARMS had the best discriminative parameters. Using single parametric suspicion cut-offs of "either SimK steep >47.2 D or CCT<491.6 μ" had a good sensitivity (0.98) for central keratoconus, but not for non-central keratoconus (0.80). Changing this cut-off to "either SimK steep K≥45.8 D or CCT≤503 μ" gave a sensitivity and specificity of 0.95 and 0.87 for non-central keratoconus and 0.99 and 0.87 for central keratoconus. The study is published in Acta Ophthalmologica.
NEW PRODUCT BRIEFS
- Marco (Jacksonville, Fla.) combined its slit lamp imaging technology with the latest Apple technology to create the new Ion imaging system, debuting this weekend at the American Academy of Ophthalmology (AAO) annual meeting. Ion includes an app dedicated to anterior segment imaging that consists of: patient demographics, pre-set photography modes maximizing the various lighting techniques for video or still images, auto storage to the Cloud, and a local network for EMR or PACS integration.
- Topcon Medical Systems (Oakland, N.J.) introduced a High Definition Video Teaching System for PASCAL. The system is comprised of an HD video camera, camera control unit, power supply and interface cable.
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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 non asthmatic 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®.
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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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