FDA approves Ziemer's Femto LDV Z8
|
|
The Food and Drug Administration granted 510(k) approval for use of the FEMTO LDV Z8, the "first truly mobile femtosecond laser solution for refractive, cornea and cataract procedures to be performed on an all-in-one-system," developer Ziemer (Port, Switzerland) said in a news release.
The FEMTO LDV Z8 is approved for Z-Lasik, Z-Lasik Z, intracorneal rings, intrastromal pockets, lamellar keratoplasty, penetrating keratoplasty, anterior capsulotomy, lens fragmentation, and clear corneal and arc incisions.
|
OPUS-3 lifitegrast study meets endpoints, Shire to resubmit to FDA
|
|
Topline data from the OPUS-3 clinical study of lifitegrast demonstrated significant improvement in patient-reported symptoms from baseline to day 84 in patients receiving lifitegrast versus placebo (p=0.0007), the study's primary endpoint, developer Shire (Lexington, Mass.) said in a news release. Key secondary endpoints were also met, showing symptom improvement from baseline to days 14 and 42 versus placebo (p<0.0001); this benefit was demonstrated as early as two weeks, Shire added.
The positive results will be used as part of Shire's resubmission to the Food and Drug Administration. With the additional results from OPUS-3, lifitegrast has now been studied in more than 2,500 patients.
|
Dextenza, OTX-TP topline results reported
|
|
Ocular Therapeutix (Bedford, Mass.) reported topline results on two product candidates: Dextenza (sustained release dexamethasone) 0.4 mg, Intracanalicular Depot for the treatment of allergic conjunctivitis, and OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension.
In the Dextenza phase 3 study, there was a statistically significant difference (p<0.0001) in the mean scores between the Dextenza treatment group and the placebo group for ocular itching at all three time points measured on day 7 post-insertion of the drug product. The difference in the scores for ocular itching between the Dextenza group and the placebo group was greater than 0.5 units at all time points on day 7 post-insertion and was greater than 1 unit at a majority of the time points on day 7 post-insertion. Dextenza did not achieve the primary endpoints for conjunctival redness in this trial, the company said.
In the company's phase 2b clinical trial of OTX-TP, the duration of effect as measured by the clinically meaningful reduction of intraocular pressure (IOP) in the 4.5-5.7 mm Hg range was observed out to 90 days with the sustained release OTX-TP drug product. This IOP lowering was comparable to levels seen in the treatment group with the same drug release rate in the phase 2a clinical trial of OTX-TP. As with earlier studies, this one was not powered to detect statistically significant differences in IOP-lowering between patient groups.
|
Fovista phase 3 recruitment complete
|
|
Patient recruitment for a second phase 3 trial of Fovista (pegpleranib, Ophthotech, New York) in combination with Lucentis (ranibizumab, Genentech, South San Francisco) for the treatment of wet age-related macular degeneration (AMD) is now complete, Ophthotech said in a news release. Topline data is expected in the fourth quarter of 2016.
The two phase 3 trials investigating the superiority of Fovista in combination with Lucentis compared to Lucentis monotherapy are identical with respect to the trial design in the first year. As a result, the data will be pooled and analyzed together, the company said.
A third phase 3 trial, which is investigating Fovista in combination with either Eylea (aflibercept, Regeneron, Tarrytown, N.Y.) or Avastin (bevacizumab, Genentech), continues to enroll patients with recruitment on track.
|
Topical presbyopia treatment study enrolls first patient
|
|
The first patient has been enrolled in the phase 1 and 2 study investigating EV06, a topical ophthalmic solution to treat presbyopia, developer Encore Vision (Forth Worth, Texas) said in a press release.
EV06 is a first-in-class proprietary lipoic acid choline ester compound that targets a biochemical cause of presbyopia, believed to be associated with an increase in the formation of disulfide bonds between the crystalline proteins within lens fiber cells. EV06 is intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects. EV06 is a prodrug that penetrates the cornea and is subsequently broken down into lipoic acid and choline, two naturally occurring substances.
The 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.
|
|
RESEARCH BRIEFS
- The 5-year results from the ARMOR (Antibiotic Resistance Monitoring in Ocular Microorganisms) surveillance study show prevalent methicillin resistance among staphylococcal isolates from ocular infections, with many strains demonstrating multidrug resistance, according to Penny Asbell, MD, and colleagues. They reported the antibiotic resistance profiles of 3,237 ocular isolates submitted from 72 centers in the United States from January 1, 2009 through December 31, 2013. The study collected ocular strains of Streptococcus pneumoniae, Staphylococcus aureus, coagulase-negative staphylococci (CoNS), Pseudomonas aeruginosa, and Haemophilus influenzae, organisms frequently implicated in bacterial eye infections, some with potentially serious consequences. Methicillin resistance was found among 493 S. aureus isolates (42.2%) and 493 CoNS isolates (49.7%), and methicillin-resistant (MR) isolates had a high probability of concurrent resistance to fluoroquinolones, aminoglycosides, or macrolides (P<0.001). Multidrug resistance to 3 or more additional antibiotic classes continues to be a challenge and was found in 428 MR S. aureus isolates (86.8%) and 381 MRCoNS isolates (77.3%). All staphylococcal isolates were susceptible to vancomycin. Resistance among S. pneumoniae isolates was highest for azithromycin (113 isolates [34.2%]), whereas resistance among P. aeruginosa and H. influenzae was low against the antibiotics tested. Staphylococcal isolates from elderly patients were more likely to be MR, as were S. aureus isolates obtained from the southern United States (P<0.001). Methicillin resistance among staphylococci did not increase during the 5-year study period (P≤0.22), and small decreases in resistance to ciprofloxacin among CoNS and MRCoNS and to tobramycin among CoNS (P≤0.03) were found. The study is sponsored by Bausch + Lomb and published in JAMA Ophthalmology.
- A new technique described by T.P. Page may be able to reduce the risk of iatrogenic zonular damage. In the Journal of Cataract & Refractive Surgery, Dr. Page explains that while the capsular tension ring (CTR) is a useful device for managing a zonular dialysis, insertion of the CTR has potential complications. The CTR can damage zonular fibers during deployment into the capsular bag. Also, the angle and point of initial contact of the CTR with the capsular bag relative to the orientation of the dialysis must be considered to avoid damage to the zonular fibers. Adequate fill of the capsular bag with an ophthalmic viscosurgical device is important to minimize the risk for capsule entanglement with the leading eyelet of the CTR. A simple technique using suture-guided CTR insertion to maintain the intended shape and direction of implantation can be used with both standard and modified CTRs. After the CTR has been safely and fully deployed, the suture will remain in the leading eyelet as it comes to rest in the fornix of the capsular bag. The suture can be cut at the incision and simply pulled on one end to remove it from the eyelet.
- Rates of ocular comorbidities vary by axial length, according to A.C. Day and colleagues. They prospectively collected anonymized data on 180,114 eyes (127,685 patients) undergoing cataract surgery between August 2006 and November 2010 at 28 sites in England. Consultant surgeons performed a higher proportion of operations on eyes whose axial length were at the extremes. Glaucoma and age-related macular degeneration were more common in eyes with shorter axial lengths, while previous vitrectomy was associated with longer axial lengths. Eyes with brunescent or white cataracts or amblyopia were more common at both axial length extremes. Preoperative visual acuities were similar for eyes with axial length measurements up to approximately 28 mm and worse for eyes with longer axial length measurements. Posterior capsule rupture showed little change with axial length. The study is published in Eye (London).
|
|
|
|
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. |
|
|
|
|
