EyeWorld Weekly Update, January 5, 2018

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January 5, 2018
Volume 24 , Number 1

FDA approves brimonidine tartrate ophthalmic solution for eye redness

The U.S. Food and Drug Administration (FDA) approved brimonidine tartrate ophthalmic solution 0.025% (Lumify, Bausch + Lomb, Bridgewater, New Jersey) as an over-the-counter eye drop for ocular redness. The agent uses a lower dose of brimonidine tartrate. Brimonidine was first approved by the FDA in 1996 for reducing IOP in glaucoma patients, according to a company press release. The agent is also available at higher doses in prescription products.

IDE application submitted to FDA for iStent infinite Trabecular Micro-Bypass System

Glaukos (San Clemente, California) submitted an Investigational Device Exemption (IDE) application to the FDA to study its iStent infinite Trabecular Micro-Bypass System, according to a company press release. The iStent infinite is to be used as a standalone procedure to lower IOP in refractory glaucoma patients and includes three heparin-coated titanium stents that are preloaded into an auto-injection system. They allow the surgeon to inject stents across 5 to 6 clock hours around Schlemm's canal. The IDE application proposes a prospective, multicenter, single-arm clinical trial to evaluate the safety and performance of the iStent infinite in an estimated 65 refractory subjects and/or subjects on maximally tolerated topical ocular hypotensive medications. The primary endpoint will be a 20% or greater lowering of the IOP from baseline at 12 months on the same or fewer medications. The trial results may become the basis to seek FDA clearance via a 510k premarket submission.

Tentative approval obtained for generic Prolensa

The U.S. FDA has given tentative approval to the generic version of Prolensa (bromfenac ophthalmic solution 0.07%, Bausch + Lomb), according to a press release from Perrigo (Dublin, Ireland), the maker of the generic version. Bromfenac is a nonsteroidal anti-inflammatory drug used to treat postoperative inflammation and to reduce ocular pain after cataract surgery. Although Perrigo had previous litigation with Bausch + Lomb regarding this product, that has now been settled.

New Drug Application accepted for OTX-101, a dry eye treatment

The FDA accepted a New Drug Application for cyclosporine A ophthalmic solution 0.09% (OTX-101, Sun Pharma, Mumbai, India), according to a company press release. The agent is a nanomicellar formulation of cyclosporine A 0.09% in a clear, preservative-free aqueous solution. The company previously announced top line Phase 3 results from the agent's clinical trial, during which the treatment of 744 dry eye patients with OTX-101 or its vehicle over 12 weeks led to a statistically significant improvement in the primary endpoint for those using OTX-101. If approved, the agent will be commercialized in the U.S. by Sun Ophthalmics (Princeton, New Jersey).

Health Canada approves lifitegrast ophthalmic solution for dry eye disease

Lifitegrast ophthalmic solution 5% (Xiidra, Shire, Lexington, Massachusetts) has been approved in Canada to treat the signs and symptoms of dry eye in adults. This is the company's first international approval for treatment outside the U.S. Xiidra will be available to Canadian patients early this year.

Positive results found in Phase 1/2 study of SF0166 eye drops to treat wet AMD

A double-masked Phase 1/2 trial with SF0166 (SciFluor, Cambridge, Massachusetts) reported positive results, according to a company press release. The trial examined the safety, tolerability, and preliminary efficacy of SF0166 in 42 subjects with neovascular age-related macular degeneration (AMD) randomized 1:1 to self-administer an eye drop with a 2.5% or 5% solution of twice daily SF0166 for 28 days. The mean visual acuity improvement during the treatment period among treatment-naïve patients was about five letters. The drug was also well tolerated.

Intravitreal sirolimus not approved by the FDA

In a complete response letter, the FDA announced to Santen Pharmaceutical (Osaka, Japan) that it did not approve intravitreal sirolimus for the treatment of posterior segment noninfectious uveitis. "The complete response letter indicates that the FDA is unable to approve the application in its present form and requests additional substantiating evidence to demonstrate efficacy of IVT sirolimus," according to a company press release. Santen leaders are evaluating the FDA response and working closely with the agency on how to best respond.

510(k) clearance given to Crystalsert 2.6 injector

The FDA has given 510(k) clearance to the Crystalsert 2.6 injector (Bausch + Lomb), designed for use across the entire diopter range of Crystalens AO and Trulign toric IOLs.

RESEARCH BRIEFS

  • Ophthalmologists have an overall negative perception of electronic health records (EHRs), according to a population-based cross-sectional survey led by Michele Lim, MD. At the same time, adoption of EHRs has doubled since a 2011 survey, to 72.1%. A random sample of 2,000 ophthalmologists was generated using the American Academy of Ophthalmology database. Surveys were emailed to potential participants. Among the 348 respondents, ophthalmologists perceived that their net revenues and productivity had declined with EHRs and that their practice costs were higher. Compared with previous surveys, respondents had more negative perceptions of EHRs. More attention should be given to improving the efficiency and usability of EHRs, the researchers concluded. The study appears in JAMA Ophthalmology.
  • There was high efficacy, predictability, and safety after retreatment post-hyperopic LASIK, according to a retrospective case series led by Andreas Frings, MD. Researchers in the multicenter study included 113 eyes of 113 consecutive hyperopic patients. The study included patients with a preop difference between cycloplegic and manifest refraction of 1 D or less who had LASIK retreatment based on manifest refraction. Both efficacy (P<.001) and safety (P=.004) improved significantly with retreatment and were not negatively influenced by preop manifest spherical equivalent, manifest cylinder, or keratometry. In cases with a trend toward undercorrection, 78% of eyes that were retreated with within ±0.50 D of the attempted correction. The research is published in the Journal of Cataract & Refractive Surgery.
  • Personalized therapy via the use of OCT has helped achieve cost savings within ophthalmology, according to Matthew Windsor and co-researchers. Their observational cohort study aimed to compare patient and Medicare savings from the use of OCT to help guide therapy for neovascular AMD to research investments made to develop OCT by the National Institutes of Health (NIH) and the National Science Foundation (NSF). Researchers tracked Medicare spending as tracked by Current Procedural Terminology codes on intravitreal injections, retinal OCT imaging, and antivascular endothelial growth factor (VEGF) treatment-specific J-codes. Research costs for OCT were determined by searching for grants awarded by NIH and NSF from inception to 2015; costs and savings were discounted by 3% annually and adjusted for inflammation to 2015 dollars. Between 2008 and 2015, the U.S. government and neovascular AMD patients accrued a cost savings of $9 billion and $2.2 billion, respectively, from the use of OCT to guide personalized anti-VEGF treatment. The $9 billion represents a 21-fold return on government investment into development of the technology through NIH and NSF grants. "Although an overall cost-benefit ratio of government-sponsored research is difficult to estimate because the benefit may be diffuse and delayed, the investment in OCT over 2 decades has been recouped many times over in just a few years through better personalized therapy," the researchers concluded. The study is published in the American Journal of Ophthalmology.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

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 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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