EW Weekly, May 13, 2016

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May 13, 2016
Volume 21 , Number 17

CyclASol DED study enrolls last patient

Patient enrollment in a phase 2 study evaluating the safety, efficacy and tolerability of CyclASol for the treatment of moderate to severe dry eye disease (DED) is now complete, said developer Novaliq (Heidelberg, Germany) in a news release. CyclASol is a clear, preservative-free ophthalmic solution of cyclosporine A formulated using Novaliq's proprietary EyeSol technology. The double-masked, placebo-controlled, multicenter study enrolled 207 patients who were randomized to 1 of 4 treatment groups that included 2 CyclASol groups, a placebo (vehicle control) group and an open label cyclosporine A 0.05% ophthalmic emulsion group. Study subjects are self-administering 1 drop twice daily, and returning for examination periodically and at the end of the trial at 4 months. The trial is being conducted in 4 sites in the U.S. Topline results are anticipated by the end of 2016.

OTX-TP moving into phase 3 studies

Ocular Therapeutix (Bedford, Massachusetts) has completed it end-of-phase 2 review with the U.S. Food and Drug Administration for OTX-TP (sustained release travoprost), the company's product candidate for the treatment of glaucoma and ocular hypertension. Based on this review, the company intends to initiate the first of 2 phase 3 clinical trials during the third quarter of 2016. The overall phase 3 clinical program includes the following: 2 phase 3 studies that include an OTX-TP treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot; the study will not use a timolol comparator or validation arm; and the study will not have eye drops, placebo or active, administered in either arm. A primary efficacy endpoint is statistically superior and clinically meaningful reduction of intraocular pressure from baseline with OTX-TP compared to placebo at 60 and 90 days. The FDA has also indicated that it will take into consideration the risk-reward profile of OTX-TP relative to currently available therapies in its evaluation of the phase 3 clinical trial results.

D-EYE retinal screening captures quality photos

Using D-EYE with an iPhone 6 to obtain retinal images of pediatric patients in both outpatient and inpatient settings, on dilated and undilated eyes, is a "beneficial alternative for fundus imaging in the pediatric population," according to a news release. D-EYE (Padua, Italy) uses direct ophthalmoscopy to capture a field of view of approximately 20 degrees in a single fundus image at a distance of 1 cm from the patient's dilated eye. When examining an undilated eye, the field of view is approximately 5-8 degrees. Results of the study were presented during the American Association of Pediatric Ophthalmology and Strabismus conference.

Cyclo G6 deemed safe, efficacious

The Cyclo G6 with MicroPulse (Iridex, Mountain View, California) showed a significant mean intraocular pressure (IOP) reduction in the patient population as well as the ability to safely retreat patients, if necessary, to achieve the target pressure, according to results from a phase 3 study presented during the Association for Research in Vision and Ophthalmology meeting. Robert Noecker, MD, presented data from a study population of 45 glaucoma patients (45 eyes) with a mean preoperative IOP of 28.1 mm Hg who underwent micropulse transscleral cyclophotocoagulation with the MicroPulse P3 probe at 2.0 watts, with a total duration of 140-180 seconds at a 31.3% duty cycle. Results showed that there was a mean IOP reduction among the study population of 42% (an average of 16.4 mm Hg). Ten of the 45 patients needed retreatment with the Cyclo G6 to achieve the target IOP, and all of these patients responded to repeat treatment with MicroPulse.

Oasis Medical obtains CE mark for collagen corneal shields

Oasis Medical has obtained a CE mark for its Soft Shield Collagen Corneal Shields, which allow for ocular healing by providing a protective barrier over the surface of the eye. As the shield degrades, a thin layer of collagen is released that helps to lubricate the eye.

RESEARCH BRIEFS

  • A clinically relevant reduction in mean IOP was observed over 6 months with a bimatoprost ocular insert that seems to be safe and well tolerated, according to J. Brandt and colleagues. In their parallel-arm, multicenter, double-masked, randomized, controlled trial, 130 adult patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) were randomized to receive a bimatoprost insert plus artificial tears twice daily or a placebo insert plus timolol (0.5% solution) twice daily for 6 months after a screening washout period. The primary efficacy endpoint examined the difference in mean change from baseline in diurnal IOPs across 9 co-primary endpoints at weeks 2, 6, and 12 comparing the bimatoprost arm with the timolol arm using a non-inferiority margin of 1.5 mm Hg. A mean reduction from baseline IOP of -3.2 to -6.4 mm Hg was observed for the bimatoprost group compared with -4.2 to -6.4 mm Hg for the timolol group over 6 months. The study met the non-inferiority definition at 2 of 9 time points but was underpowered for the observed treatment effect. Adverse events (AEs) were consistent with bimatoprost or timolol exposure; no unexpected ocular AEs were observed. Primary retention rate of the insert was 88.5% of patients at 6 months. The study is published in Ophthalmology.
  • A modified accelerated corneal crosslinking (CXL) protocol provided the same treatment depth as the standard Dresden protocol, according to G.D. Kymionis and colleagues. They compared the corneal stromal demarcation line depth using anterior segment optical coherence tomography (AS-OCT) after CXL using 2 different treatment protocols: the standard Dresden protocol (30 minutes with 3 mW/cm2) and a modified high intensity protocol (7 minutes with 18 mW/cm2), corresponding to a total surface dose of 5.4 and 7.5 J/cm2, respectively. All patients (N=29; 32 eyes) underwent CXL using the same high intensity ultraviolet-A irradiation device (CCL-365; Peschke Meditrade, Hunenberg, Switzerland) and were randomized equally to each treatment arm. There was no significant difference in corneal stromal demarcation line depth between observer measurements for both groups. Mean corneal stromal demarcation line depth was 341.81±47.02 µm for the Dresden protocol group and 313.37±48.85 µm for the high intensity protocol group. There was no statistically significant difference in the corneal stromal demarcation line depth between the 2 groups. Mean endothelial cell density did not change significantly in either group (P=.090, Dresden protocol group; P=.103, high intensity group). No intraoperative or postoperative complications were noted. The study is published in the Journal of Refractive Surgery.
  • Significantly less cumulative dissipated energy (CDE), aspiration fluid used, and aspiration time were observed with the active fluidics configuration of a new phacoemulsification system than with the gravity fluidics configuration, according to Kerry Solomon, MD, and colleagues. Their prospective clinical case series randomized the first eye of 100 patients having surgery to the active fluidics configuration (Centurion Vision System with Active Fluidics, 0.9 mm 45-degree Intrepid Balanced tip, and 0.9 mm Intrepid Ultra infusion sleeve, Alcon, Fort Worth, Texas) or the gravity fluidics configuration (Infiniti Vision System with gravity fluidics, 0.9 mm 45-degree Mini-Flared Kelman tip, and 0.9 mm Ultra infusion sleeve, Alcon). Second-eye surgery was completed within 14 days after first-eye surgery using the alternate configuration. The CDE was significantly lower with the active fluidics configuration than with the gravity fluidics configuration (4.32±0.28 percent-seconds; P<.001). The active fluidics configuration used significantly less aspiration fluid than the gravity fluidics configuration (mean 46.56±1.39 mL versus 52.68±1.40 mL; P<.001) and required significantly shorter aspiration time (mean 151.9±4.1 seconds versus 167.6 ±4.1 seconds; P<.001). No serious ocular adverse events related to the study devices or device deficiencies were observed. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Leica Microsystems (Wetzlar, Germany) launched IOLcompass Pro, a software-based guidance system for preoperative planning and intraoperative positioning of premium IOLs. It "supports ophthalmic surgeons to achieve minimal residual astigmatism for their patients by providing stable and accurate guidance throughout the cataract surgical workflow," Leica said.
  • Clarity Medical Systems (Pleasanton, California) will launch the HOLOS Barrett Intraocular Lens Formula, available only on the HOLOS IntraOp Wavefront Aberrometer, by mid-year. Developed by Graham Barrett, MD, Douglas Koch, MD, and Warren Hill, MD, the new IOL predictor formula incorporates elements from validated formulae used to calculate IOL power and adds aphakic data taken at the time of surgery to provide additional accuracy of a patient's refractive needs.
  • Bausch + Lomb (Bridgewater, New Jersey) is collaborating with IBM (Armonk, New York) to develop the first app of its kind for iPhone and iPad for surgeons who perform cataract surgery. The "innovative app will help surgeons streamline their workflow by delivering patient information and clinical insights as well as IOL options on a single, digital platform at the point of care," Bausch + Lomb said in a news release. 

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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 Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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