EW Weekly, March 4, 2016

March 4, 2016
Volume 21 , Number 9

Alcon recalls Tears Naturale Free

Alcon (Fort Worth, Texas) has recalled lot KRJ006 of its Tears Naturale Free lubricant eye drops, 1% and 0.3% preservative-free as some of the single-use vials "may be filled with water rather than the product solution, and the firm cannot guarantee the sterility of the water-filled vials," according to the Food and Drug Administration's Enforcement Report.

Phase 2a study on allergicconjunctivitis shows promise

A randomized, parallel-group, single-center, double-masked, vehicle-controlled phase 2a clinical trial of topical ocular NS2 (a small molecule aldehyde trap) in subjects with induced allergic conjunctivitis demonstrated statistically significant activity of NS2 over vehicle in reducing ocular itching and tearing, said developer Aldeyra Therapeutics (Lexington, Mass.). In this study, 100 healthy men and women with at least a 2-year history of allergic conjunctivitis to grass, tree or ragweed pollen were enrolled and randomized in equal groups for treatment with topical ocular NS2 or vehicle. The clinical endpoints in the trial included patient assessment (on a 0 to 4 point scale) of ocular itching and tearing, 2 prominent inflammation-related symptoms of allergic conjunctivitis. Statistically significant differences were demonstrated for ocular itching (P<0.05) and ocular tearing (P<0.05) between NS2 and vehicle after single dose and multiple dose administration. NS2 demonstrated durable effects throughout the 3 hours following conjunctival allergen provocation test (CAPT) challenge. The effects of NS2 persisted across substantially all time points for all CAPT challenges despite a stronger than expected vehicle effect. The reductions from baseline scores were of the same magnitude seen in the CAPT model with existing therapies utilized in the treatment of allergic conjunctivitis, and peak changes exceeded one point for both ocular itching and ocular tearing scores. NS2 was generally well tolerated and there were no safety concerns during the trial. Transient and generally mild stinging was noted in the treatment arm. Two patients dropped out of the trial during treatment.

Pivotal phase 3 LHONstudy enrolls first patient

The first patient has been enrolled in both RESCUE and REVERSE, 2 parallel pivotal phase 3 trials with GS010 for the treatment of Leber's hereditary optic neuropathy (LHON), developer GenSight Biologics (Paris) said in a press release. The pivotal trials are intended to determine whether GS010 can halt or reverse vision loss associated with LHON due to the NADH dehydrogenase 4 (ND4) mutation or be effective as prophylaxis for vision loss in an eye not yet affected. The trials will also seek to identify the therapeutic window of opportunity for treatment after onset of disease. As early intervention is potentially a major factor in maximizing therapeutic success, the 2 clinical trials will focus on treating patients who have manifested visual decline for up to 1 year, GenSight said. RESCUE is expected to enroll 36 patients with an onset of vision loss up to 6 months in duration, while REVERSE is expected to enroll 36 patients with an onset of vision loss ranging from 7 to 12 months in duration. GS010 will be administered as a single intravitreal injection to 1 eye of each subject, while the fellow eye will receive a sham procedure. At the end of the initial 48-week study period, a minimal 3-year, long-term follow-up period will be initiated to determine the sustainability of efficacy outcomes and long-term safety of treatment.

ArcScan starts repeatability, reproducibility study

A multicenter study to evaluate the intraoperator repeatability and interoperator reproducibility of the Insight 100 for layered corneal thickness measurements (cornea, epithelium, and temporal epithelium) and anterior segment and lens capsule dimensions (sulcus diameter, anterior chamber depth, capsule thickness, and lens rise) will include 3 to 5 sites enrolling 20 patients each, developer ArcScan (Golden, Colo.) said in a press release. The study will involve each of 2 operators performing 5 corneal scans on 1 randomly chosen eye and 5 anterior segment/capsule scans on the fellow eye of 20 randomly chosen subjects from each site.

Conflicting views over vision screening for older adults

A U.S. Preventive Services Task Force report in JAMA ("Visual Acuity Screening Among Asymptomatic Older Adults") stated that current evidence doesn't allow for assessment of clear recommendation supporting the use of visual acuity (VA) in screening those 65 and older who have no symptoms and are not already under eyecare. However, an editorial in JAMA highlights some difficulties in carrying out the recommendations of the task force and the possible implications of ongoing change in the care delivery system. Those difficulties include the high degree of rigor that makes it challenging to complete the randomized clinical trials with the specific population, and the time required to conduct appropriate studies might not be able to keep up with changes in current health delivery approaches.


  • A comparison of the accuracy of 5 biometric formulas (SRK II, SRK/T, Holladay I, Hoffer Q, and Binkhorst II) for predicting postoperative refraction determined using applanation A-scan ultrasound found the highest postoperative myopic shift is with the Holladay I for average and long eyes and SRK/T for short eyes. F. Özcura and colleagues retrospectively compared 485 eyes that underwent uneventful phacoemulsification with IOL implantation that had applanation A-scan ultrasound biometry and postop manifest refraction obtained in all eyes. All eyes were divided into 3 groups according to axial length: short (≤22.0 mm), average (22.0-25.0 mm), and long (≥25.0 mm) eyes. The results showed that all formulas had significantly lower mean absolute error (MAE) in comparison with the Binkhorst II formula (P<0.01). The lowest MAE was obtained with the SRK II for average (0.49±0.40 D) and short (0.67±0.54 D) eyes and the SRK/T for long (0.61±0.50 D) eyes. The highest postoperative hyperopic shift was seen with the SRK II for average (46.8%), short (28.1%), and long (48.4%) eyes. The highest postoperative myopic shift was seen with the Holladay I for average (66.4%) and long (71.0%) eyes and the SRK/T for short eyes (80.6%). The SRK II formula produced the lowest MAE in average and short eyes and the SRK/T formula produced the lowest MAE in long eyes. The SRK II had the highest postoperative hyperopic shift in all eyes. The study is published in International Ophthalmology.
  • When administered at the time of cataract surgery in patients with diabetic macular edema (DME), at 6 months both triamcinolone (TA) and bevacizumab improve visual acuity; however, only TA results in a sustained reduction in central macular thickness (CMT), according to L.L. Lim and colleagues. Their prospective, single-masked study evaluated 41 patients (mean age 66.4 years, 73.2% male) and randomized them to receive intravitreal bevacizumab 1.25 mg or TA 4 mg during cataract surgery. Visual acuity and CMT were similar between groups at baseline (p>0.2). After 6 months, the TA group gained a mean +21.4 letters and the bevacizumab group gained a mean +12.5 letters with no significant difference between groups. Those in the TA group had a sustained reduction in CMT (-43.8 μm), whereas the bevacizumab group had an increase of +37.3 μm. Following surgery, additional injections were required in 70.6% of participants in the bevacizumab group, compared to 16.7% in the TA group (p<0.0001). Three patients in the TA group experienced a rise of intraocular pressure over 21 mm Hg (12.5%) during the 6-month follow-up; none of the patients in the bevacizumab group had pressure increases. There were no cases of endophthalmitis in either group. The study is published in Clinical and Experimental Ophthalmology.
  • Chronic dry eye is uncommon after PRK and LASIK, according to a new study by Kraig S. Bower, MD, and colleagues. He and colleagues at the Walter Reed Army Medical Center prospectively evaluated 143 active duty U.S. Army personnel, ages 29.9±5.2 years, with myopia or myopic astigmatism (manifest spherical equivalent −3.83±1.96 D) who were undergoing PRK or LASIK. Schirmer scores, corneal sensitivity, ocular surface staining, surface regularity index, and responses to dry eye questionnaire significantly changed over time after PRK. After LASIK, significant changes were observed in tear break-up time, corneal sensitivity, ocular surface staining, and questionnaire responses. At 12 months postop, 5.0% of PRK and 0.8% of LASIK participants developed chronic dry eye. Regression analysis showed that preoperatively lower Schirmer score will significantly influence development of chronic dry eye after PRK, whereas lower Schirmer score or higher ocular surface staining score preoperatively will significantly influence the occurrence of chronic dry eye after LASIK. The study is published in the Journal of Cataract & Refractive Surgery. 


  • Bausch + Lomb (Bridgewater, N.J.) introduced the Ultra for Presbyopia contact lenses, a monthly replacement silicone hydrogel lens that combines the company's MoistureSeal technology with the 3-zone progressive design found in Biotrue ONEday for Presbyopia daily disposable contact lenses.

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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