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FDA approves Alcon's pre-loaded IOL system
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The Food and Drug Administration has granted approval for the AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System for patients undergoing cataract surgery, said developer Alcon (Fort Worth, Texas). The system "combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize the implantation of the AcrySof IQ Aspheric IOL into the cataract patient's eye," the company said in a news release.
Among the system highlights: a tension-guided plunger, a smaller nozzle tip to allow for corneal incisions down to 2.2 mm, and a "depth guard" that prevents the device from being inserted deeper into the incision than the surgeon has deemed necessary.
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The Harmoni Modular Intraocular Lens System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed has been granted the CE mark, developer ClarVista Medical (Aliso Viejo, Calif.) said in a news release.
The modular design is intended to "enable safe and easy exchange of the optic component to reduce residual postoperative refractive error at the time of the primary surgery or at 3 months postoperatively," the company said.
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Oraya's wet AMD treatment deemed effective in "real world"
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Leading ophthalmologists from three European countries said real world data on Oraya's therapy for the treatment of wet age-related macular degeneration is effective in maintaining vision with reduced injections for patients at different stages of their disease, from chronic patients in discontinuous treatment to treatment-naive patients with new diagnosis, and following different treatment pathways.
Chronic patients treated with the Newark, Calif.-based company's stereotactic, low-voltage X-rays maintained vision with less fluid in the macula and fewer injections compared to same-patient history. These patients experienced a significant 40% to 74% reduction in the number of injections required to maintain vision compared to their previous injection needs, with a corresponding significant decrease in macular edema characterized by a decrease in central macular thickness.
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Positive p3 data on gene therapy for retinal dystrophies
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Positive top-line results from the phase 3 pivotal trial of SPK-RPE65, for the treatment of RPE65-mediated inherited retinal dystrophies (IRDs), show the gene therapy reached its primary endpoint, developer Spark Therapeutics (Philadelphia) said in a news release.
The pivotal trial met its primary endpoint of demonstrating improvement of functional vision in the intervention group compared to the control group, as measured by the change in bilateral mobility testing between baseline and 1 year.
In addition, subjects who received SPK-RPE65 outperformed control subjects across the first two secondary endpoints: full-field light sensitivity threshold testing and the mobility test change score for the first injected eye. The third secondary endpoint, visual acuity, did not show statistically significant evidence of benefit. Spark plans on filing a Biologics License Application in 2016.
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Travoprost XR reaches primary endpoint in p2a trial
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ENV515 (travoprost XR) has achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in IOP with results comparable to topical once-daily Travatan Z (travoprost ophthalmic solution, Alcon, Fort Worth, Texas), developer Envisia Therapeutics (Research Triangle Park, N.C.) said in a news release.
ENV515 is engineered as a proprietary, fully biodegradable PRINT (Particle Replication In Non-Wetting Templates) travoprost formulation that "could offer sustained reduction in IOP for more than 6 months after a single dose," the company said. If successful, 1-2 injections of ENV515 a year in the doctor's office "could satisfactorily control the IOP in most patients without the need for additional eye drops," Envisia said.
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First patients enrolled in trial on topical treatment for presbyopia
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A combined phase 1 and phase 2 study to evaluate EV06 (lipoic acid choline ester, 1.5%) topical ophthalmic solution to treat presbyopia has enrolled its first subjects, developer Encore Vision said. EV06 represents "the first ever clinical evaluation of a new chemical entity intended to address an underlying process that causes presbyopia."
The phase 1/2 prospective, randomized, double-masked, multicenter study will compare the safety and efficacy of EV06 to placebo in subjects 45 to 55 years of age with presbyopia. The 90-day study will aim to enroll 72 subjects and evaluate mean change in distance corrected near visual acuity and best corrected distance visual acuity, along with additional secondary outcomes.
EV06 is a first-in-class new chemical entity intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects.
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MS linked to poor visual neuropsychological testing
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Researchers have found that individuals with multiple sclerosis (MS) who had a history of neuro-ophthalmic syndromes performed poorly on visual neuropsychological tasks, according to the Kessler Foundation (West Orange, N.J.).
Blurred vision, diplopia, and nystagmus are among the symptoms of the neuro-ophthalmic syndromes seen in MS. Visual symptoms may be harbingers of MS, or occur during the clinical course of the disease. Although neuro-ophthalmic syndromes and cognitive symptoms are common among people with MS, few studies have looked at the relationship between these two conditions. In this study, 9 healthy controls were compared with 18 participants with relapsing-remitting MS and normal visual acuity. In the MS group, 12 had a history of neuro-ophthalmic syndromes and 6 did not.
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RESEARCH BRIEFS
- Wavefront-guided LASIK performed using data derived from the new Hartmann-Shack aberrometer was safe, effective, and predictable for treating myopia and myopic astigmatism, according to a study in the Journal of Cataract & Refractive Surgery. D. Smadja and colleagues retrospectively analyzed 100 eyes of 50 consecutive patients treated with wavefront-guided LASIK for myopia and myopic astigmatism using the VISX S4 IR excimer laser (Abbott Medical Optics, Abbott Park, Ill.) and wavefront data derived from a new Hartmann-Shack aberrometer (iDesign Advanced WaveScan aberrometer, Abbott Medical Optics). Refractive (refraction and refractive accuracy) and visual outcomes (uncorrected [UDVA] and corrected [CDVA] distance visual acuities) were recorded 3 months postoperatively. The mean decimal UDVA improved from 0.1±0.1 preoperatively to 1.1±0.15 postoperatively (P<.01). A monocular UDVA of 20/16, 20/20, and 20/25 were achieved in 76.6%, 94.4%, and 96.6% of eyes, respectively. The postoperative manifest spherical equivalent was within ±0.5 D in all eyes. No eye lost 2 or more lines of CDVA, and 29.2% of the eyes gained 1 or more lines of CDVA.
- Hormone replacement therapy (HRT) use may improve aqueous tear production but not the quality of tears in dry eye syndrome (DES), and the effect on tear production is dependent on age, according to Y. Feng and colleagues. A total of 88 women with DES at least 1 year after spontaneous menopause were randomly divided into the HRT group that were treated with oral estrogen and medroxyprogesterone acetate or a control group that did not receive any treatment. After one-month follow-up, HRT use improved the Schirmer test, but the effect was significant only for participants less than 50 years old. The improvement in Schirmer test result was negatively correlated with the age of the participants. The tear break-up time did not change significantly within each group after HRT use. The study is published in Contact Lens & Anterior Eye.
- Corneal thickness does not influence the penetration of topically applied vancomycin into the anterior chamber, according to O. Spierer and colleagues. The study included 58 eyes of 58 patients undergoing phacoemulsification cataract extraction. The central corneal thickness was measured by ultrasonic pachymetry on the day of surgery. Thirty minutes before the surgery, one drop of topical vancomycin 50 mg/mL was instilled three times with 10-minute intervals: 30 minutes, 20 minutes, and 10 minutes before the surgery. There were a total of 49 usable samples; the mean vancomycin concentration in the anterior chamber was 0.220 (±0.209) μg/mL. There was no significant association between vancomycin concentration and corneal thickness. When patients were divided into three groups based on the mean (±1 SD) central corneal thickness, no significant differences in vancomycin concentrations (in micrograms per milliliter) were encountered: 0.267 (±0.247) (for corneal thickness <500.2 μm), 0.209 (±0.212) (for corneal thickness of 500.2 to 579.2 μm), and 0.200 (±0.160) (for corneal thickness >579.2 μm) (p=0.73, analysis of variance). The study is published in Optometry & Visual Science.
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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.
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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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