EW Weekly, November 4, 2016

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November 4, 2016
Volume 21 , Number 40

FDA approves Restasis Multidose

The Food and Drug Administration (FDA) has approved Restasis Multidose (cyclosporine 0.05%), a preservative-free, multi-dose bottle for the treatment of dry eye, marketer Allergan (Dublin, Ireland) said in a press release. Restasis Multidose "is designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative. The new multi-dose bottle uses less plastic than a package of single-use vials and will be available for the same price," Allergan said.

Rocket 4 Phase 3 trial meets endpoints

The Rocket 4 Phase 3 clinical trial of Rhopressa (netarsudil, Aerie Pharmaceuticals, Irvine, California) achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily formulation compared to twice-daily timolol. The Rocket 4 trial is designed to provide adequate 6-month safety data for European regulatory filing purposes, but is not necessary for U.S. filings, Aerie said in a press release. Rhopressa dosed once daily achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol for patients with baseline IOPs ranging from above 20 to below 25 mm Hg. It also demonstrated non-inferiority compared to timolol at the pre-specified secondary endpoint range of above 20 mm Hg to below 27 mm Hg, and at a range of above 20 mm Hg to below 28 mm Hg. The most common Rhopressa adverse event was hyperemia, which was reported in approximately 40% of patients; 85% was scored as mild. Separately, Aerie announced that it has withdrawn the Rhopressa New Drug Application that was submitted to the FDA in the third quarter of 2016, stating a third-party manufacturing facility was not ready for a pre-approval inspection. The company plans to refile in January 2017 when the manufacturing facility will be prepared.

iStent effective in Hispanic glaucoma patients

A study of 134 predominantly Hispanic eyes with open-angle glaucoma (OAG) found the iStent (Glaukos, San Clemente, California) produced a mean IOP of 12.9 mm Hg and a 61% decrease in mean medication burden 1 year following implantation with concurrent cataract surgery, the company said. The retrospective, consecutive case series includes 168 eyes (128 patients) who underwent iStent implantation with concomitant cataract surgery, and 134 eyes (100 patients) have been followed through 1 year. In the first of three groups, mean IOP decreased to 12.7 mm Hg, compared to 13.6 mm Hg preoperatively. In the second group, mean IOP was 12.6 mm Hg, compared to 19.1 mm Hg preoperatively. In the third group, mean IOP decreased to 13.6 mm Hg, compared to 19.3 mm Hg preoperatively, which was statistically significant ( P<0.001).

RESEARCH BRIEFS

  • A new formula with three preoperative parameters-angle-to-angle (ATA) depth, preoperative anterior chamber depth (ACD), and axial length (AL)-predicted postoperative ACD more accurately than the SRK/T and Haigis formulas, according to S. Goto and colleagues. In this retrospective, consecutive case series, 304 eyes (276 patients) implanted with acrylic IOLs were divided randomly into a training set (152 eyes) and a validation set (152 eyes). The main outcome measures included postop ACD, median absolute prediction error of postoperative ACD, and ocular biometric parameters. In the training set, ATA depth yielded the highest standard partial regression coefficient value, indicating that ATA depth is the most effective parameter for predicting postoperative ACD. In the validation set, the postoperative ACDs of the new formula, the SRK/T formula, and Haigis formula were predicted with R2 of 0.71, 0.36, and 0.55, respectively, and the medians of the absolute prediction errors were 0.10 mm, 0.65 mm, and 0.30 mm, respectively. The absolute prediction error with the new formula was significantly smaller than those obtained with the SRK/T and Haigis formulas (P<0.0001). The study is published in Ophthalmology.
  • As more surgeons become aware of intraoperative floppy iris syndrome (IFIS), the number of cases and the percentage of females are higher compared to in previous reports, according to M. Wahl and colleagues. They evaluated the association between IFIS and concurrent medications containing selective alpha1A receptor antagonists as well as nonselective alpha1-adrenergic receptor antagonists, bulbus length, patient age and gender in all patients undergoing cataract surgery over a 6-month period. IFIS was observed in 119 of 947 cases (12.6%). In 31 of those 119 patients (26.1%), patients used a concurrent medication with a drug that is associated with a higher risk of causing IFIS. Tamsulosin was the drug most commonly associated with IFIS (n=11), followed by a combination of drugs (n=7), doxazosin (n=4), quetiapine (n=4), finasteride (n=2), prothipendyl (n=2), and mianserin (n=1). Bulbus length and age did not show any significant association with occurrence or grade of IFIS. Gender distribution among IFIS cases was 57.1% males (n=68) and 42.9% (n=51) females. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • Combined cataract surgery and trabecular microbypass stent implantation was statistically effective in reducing IOP and/or medication burden in open-angle glaucoma (OAG) patients with a low preoperative IOP, according to Leonard K. Seibold, MD, and colleagues. They analyzed 64 eyes (45 patients) to evaluate treatment success (defined as a 20% or more IOP reduction or discontinuation of at least one medication). At 1 year, the mean IOP was significantly reduced from 14.7±3.2 mm Hg (SD) to 13.2±2.8 mm Hg (P<.01) and the mean medication use decreased from 1.81±1.13 to 1.41±1.48 (P=.0001). The estimated IOP reduction at 1, 3, 6, and 12 months was 3.5% (P=.23), 7.9% (P=.04), 9.7% (P=.01), and 12.2% (P=.002), respectively. Treatment success at 1 year was achieved in 76.1% of patients, and 41% of patients were medication free at 1 year. The corrected distance visual acuity was significantly improved from 0.4±0.38 logMAR at baseline to 0.17±0.35 at 1 year (P<.0001). The study is published in the Journal of Cataract & Refractive Surgery. 

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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