|
B+L's chandelier fiber optic illuminator granted 510(k) clearance
|
|
An adjustable chandelier fiber optic illuminator in 23- and 25-gauge versions, which has been designed specifically for the Stellaris PC Vision Enhancement System, was granted 510(k) clearance, developer Bausch + Lomb (B+L, Bridgewater, N.J.) said in a news release.
The adjustable chandelier will give surgeons uniform, diffused lighting and modifiable light control "to help provide excellent intraocular visibility and efficiency during vitreoretinal procedures," B+L said.
The chandelier works transscleral or integrates seamlessly with the Entry Site Alignment (ESA) valved cannulas.
|
|
Positive results from Rhopressa p3 study
|
|
A second phase 3 study for Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, has achieved its primary efficacy endpoint, demonstrating non-inferiority when compared to timolol, developer Aerie Pharmaceuticals (Irvine, Calif.) said in a news release. The compound inhibits both Rho-kinase and norepinephrine transporter, the company noted.
The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mm Hg. The Rocket 2 efficacy results demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period for Rhopressa, Aerie said. The company expects to file its New Drug Application for Rhopressa in mid-2016.
|
|
First patients enrolled in Thymosin beta-4 dry eye trial
|
|
RegeneRx Biopharmaceuticals (Rockville, Md.) has enrolled its first patients in a phase 2b/3 clinical trial with RGN-259 (Thymosin beta-4), its sterile, preservative-free eye drop formulation developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders, the company said.
The double-masked, placebo-controlled trial is being conducted at 4 sites and will enroll approximately 350 dry eye patients; completion is expected by the end of the first quarter of 2016. The co-primary endpoints are assessments of total corneal staining and reduction of ocular discomfort in patients using RGN-259 compared to those using placebo. Patients will use the eye drops 4 times daily for 28 days, RegeneRx said.
|
|
Autoimmune uveitis therapy granted orphan drug designation
|
|
Col-Treg, a personalized T-cell immunotherapy using collagen-II specific regulatory T-cells for the treatment of chronic non-infectious uveitis, has been granted Orphan Drug Designation (ODD) in the U.S., developer TxCell (Valbonne, France) said in a press release. The designation had previously been granted in Europe.
TxCell plans to move Col-Treg into a first clinical study in 2016, with top line results expected by the end 2017, the company said.
|
|
Genetic interaction offers potential new glaucoma therapy target
|
|
Scientists at the University of California, San Diego School of Medicine have explained a genetic interaction that may prove key to the development and progression of glaucoma, the university said. Recent genome-wide association studies have identified two genes, SIX1-SIX6 and p16INK4a, as strongly associated with primary open-angle glaucoma (POAG), the university said. SIX6 is required for proper eye development, and P16INK4a irreversibly arrests cell growth.
Kang Zhang, MD, professor of ophthalmology and chief of ophthalmic genetics, Shiley Eye Institute, and colleagues reported that some variants of SIX6 boost expression of p16INK4a, which in turn accelerates senescence and death of retinal ganglion cells. Inhibiting p16INK4a may be a new therapeutic target, Dr. Zhang's group suggests. They plan to initiate preclinical studies on the targets in the near future.
|
|
Sun Pharma to buy InSite Vision
|
|
Sun Pharma (Mumbai, India) will buy InSite Vision (Alameda, Calif.) in an all-cash transaction worth about $48 million, the two groups announced. InSite has terminated its previously announced second amended and restated merger agreement with QLT after the board of directors determined Sun's offer provided "a significant improvement in value for our stockholders," InSite said.
|
|
Robert Califf, MD, nominated as next FDA commissioner
|
|
President Barack Obama has nominated cardiologist Robert Califf, MD, to serve as commissioner of the U.S. Food and Drug Administration, the White House announced.
If confirmed by the Senate, Dr. Califf would replace Stephen Ostroff, MD, who has served as acting commissioner for the past few months.
|
|
RESEARCH BRIEFS
- Atropine 0.01% reduces childhood myopic progression and should be considered for lower levels of myopia, according to Tiana Y. Clark and Robert A. Clark. They retrospectively evaluated 56 children (6-15 years) with initial myopic spherical equivalents from −0.25 to −8.00 D. The primary measure was the rate of myopic progression per year. Secondary measures were the proportions of subjects with minimal or rapid myopic progression and atropine-related side effects. After 1.1±0.3 years of follow-up, atropine subjects had significantly lower rates of myopic progression (−0.1±0.6 D/year) than controls (−0.6±0.4 D/year) (P=0.001), including 20/28 (71%) with myopic progression ≤ −0.25 D/year vs. only 5/28 (18%) controls. Three atropine and 4 control subjects had myopic progression ≥ −1.00 D/year. For subjects with low initial myopia (≤ −1.00 D), 7/9 (78%) atropine subjects had plano or slightly hyperopic refractive changes after 1 year, whereas 9/9 (100%) controls were more myopic. Only 3 atropine subjects complained of intermittent blur or light sensitivity, not symptomatic enough to discontinue treatment. The study is published in the Journal of the AAPOS.
- Amniotic membrane transplant (AMT) exhibits potential as an alternative to mitomycin-C (MMC) in trabeculectomy surgery, according to H.A. Khairy and M.F. Elsawy. This study was a patient-masked, randomized, controlled comparison trial involving 52 eyes (52 patients) with bilateral primary open-angle glaucoma. Patients were randomized to receive trabeculectomy with AMT or trabeculectomy with MMC. The main outcome for comparison was the pressure-lowering effect of both procedures. Surgical success was considered if the patient's intraocular pressure (IOP) was <22 mm Hg, and the IOPs were lowered by >20% without the use of any medication. All patients showed significantly (P<0.05) lower IOP on the first postoperative day compared with their respective preoperative IOP with non-significant (P>0.05) difference between both study groups. Patients in the AMT group showed lower IOP compared with those included in the MMC group throughout the follow-up period; however, the difference was not statistically significant at any point of the study period. The article is published in the Journal of Glaucoma.
- Two-year results indicate that the application of prophylactic collagen crosslinking (CXL) concurrently with high-myopic LASIK appears to improve refractive and keratometric stability, presumably by affecting corneal biomechanical properties, according to A. John Kanellopoulos, MD. This consecutive, randomized, prospective, comparative study enrolled 140 consecutive eyes that had myopic LASIK. Of those, 65 eyes underwent concurrent high-fluence CXL. In the LASIK-CXL eyes, the mean postoperative MRSE was −0.18±17.0 D from −6.67±2.14 D preoperatively. The postoperative flat K was 37.67 D from 43.92 D, and the steep K was 38.38 D from 45.15 D. The correlation coefficient of spherical equivalent (SE) correction predictability was 0.975. In the LASIK-only eyes, the mean postoperative manifest refraction spherical equivalent was −0.32±0.24 D from −5.49±1.99 D preoperatively. The flat K was 38.04 D from 43.15 D, and the steep K was 38.69 D from 44.03 D. The correlation coefficient of SE correction predictability was 0.968. The differences between the 2 groups at the 20/20 and 20/25 levels were statistically significant (P=.045 and P=.039, respectively). The study is published in the Journal of Cataract & Refractive Surgery.
NEW PRODUCT BRIEFS
- Reichert Technologies (Buffalo, N.Y.) launched the Ocular Response Analyzer G3, the "only tonometer capable of measuring corneal hysteresis," the company said. This third generation device provides fully automated alignment and a unique chinrest-less design, Reichert said.
|
|
|
|
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. |
|
|
|
|
