EW Weekly, July 20, 2018

July 20, 2018
Volume 24 , Number 26

Nasal spray to treat dry eye meets Phase 2 primary endpoints

A Phase 2 clinical trial for a nasal spray to treat dry eye disease, OC-02, a nicotinic acetylcholine receptor agonist, which stimulates the trigeminal parasympathetic pathway, met its primary endpoints in signs and symptoms, Oyster Point Pharma (Princeton, New Jersey) announced in a press release. The randomized, double-masked study included 165 patients with dry eye who received one of three different dose levels of the drug or the vehicle control. Schirmer's scores and patient-reported dry eye symptoms based on the Eye Dryness Scale were assessed. Researchers observed a statistically significant improvement in Schirmer's scores at all three doses compared to control, and there was a significant reduction in symptoms at the two highest doses compared to control. Adverse effects included cough and nose and throat irritation, which the company noted are common with nasal sprays.

Positive results for Phase 3 trial for neovascular age-related macular degeneration treatment

Allergan (Dublin, Ireland) and Molecular Partners (Zurich, Switzerland) announced positive results for two phase 3 clinical trials (SEQUOIA and CEDAR) it conducted for 8-week and 12-week treatment regimens with its injection abicipar, which features a new class of drugs known as DARPin. According to a press release from Allergan, safety and efficacy of abicipar were compared with ranibizumab in treatment-naive patients with neovascular age-related macular degeneration. Patients had stable vision at 52 weeks (the primary endpoint), and both studies found abicipar to be similarly effective after six or eight injections, compared to 13 ranibizumab injections. Adverse events were similar among all groups, the company stated.

Orange consumption linked to reduced risk for macular degeneration

A 15-year study of 2,000 Australian adults 50 and older found that those who regularly ate oranges were less likely to develop macular degeneration. The research out of the Westmead Institute for Medical Research found that eating at least one serving of oranges a day was correlated with a 60% reduced risk of developing this currently incurable and vision-threatening type of retinal pathology. "The data shows that flavonoids found in oranges appear to help protect against the disease," lead researcher Bamini Gopinath, BA, associate professor, University of Sydney, said in a press release. This research was published in the American Journal of Clinical Nutrition.

Valeant Pharmaceuticals changes its name

The parent company of Bausch + Lomb (Bridgewater, New Jersey), Valeant Pharmaceuticals (Laval, Canada), has changed its name to Bausch Health Companies Inc.

Combined Ophthalmic Symposium tier one deadline is July 25

Wednesday, July 25 is the tier one deadline for the ASCRS/ASOA Combined Ophthalmic Symposium, to be held August 24-26 in Austin, Texas. Register today to secure the best rates. The Ophthalmologist Program will be held on Saturday, August 25, from 8:00 a.m.-5:30 p.m. and Sunday, August 26, from 8:00 a.m.-12:30 p.m. The 2018 program chairs, Sumitra Khandelwal, MD, Douglas Koch, MD, and Douglas Rhee, MD, are joined by esteemed faculty who will deliver valuable and engaging education. The 2018 Program Preview with meeting highlights is available online, and housing can be booked through ASCRS/ASOA to reserve a discounted hotel room at the JW Marriott Austin before housing closes on Wednesday, August 8.

Research briefs

  • The technique, advantages, and early complication rates of preloaded, prestained Descemet's membrane endothelial keratoplasty (DMEK) tissue were evaluated by Lara Newman, MD, and coinvestigators in what they describe as the "first report" of this system's clinical use. Newman et al. wanted to determine whether the clinical outcomes of using preloaded DMEK injectors are comparable to that of surgeon-prepared and eye bank-prepared donor grafts. Prestripped, stained, S-stamped grafts were loaded into a Straiko-modified Jones tube and delivered to the OR 1-2 days before surgery for 111 eyes with endothelial failure. According to the results, the tissue remained well stained, and it took, on average, 3.5 minutes (a range of 0.5-11.25 minutes) to center and unscroll the graft. In terms of complications or surgical difficulties, there was no primary graft failure; 16 cases required rebubble postoperatively and of these, two required a second rebubbling. Endothelial cell loss at 3 months was 26.7% and 30.9% at 6 months. Newman et al. stated that the complication rate using preloaded grafts in this study was comparable to that of surgeon-loaded tissue. The researchers also cited surgical time saved during the preparation and loading step and reduced risk of damaging donor tissue as possible advantages of using preloaded tissue. This study is published in Cornea.
  • Treating severe dry eye with platelet-rich plasma injections was evaluated in a randomized, prospective clinical trial led by Marcel Avila, MD. Dr. Avila and coresearchers included 15 patients with Sjogren's syndrome who received injections at 0, 30, 60, and 90 days, in addition to receiving hyaluronic acid drops five times per day during the study period. Fifteen Sjogren's patients who received just hyaluronic acid at the same dose and frequency served as the control group. Those in the injection group, compared to the control, showed reduced corneal staining, increased mean Schirmer scores (5.6±0.7 to 9.0±1.1 mm), increased tear breakup time (4.0±0.4 to 6.4±0.4), and improvement in their ocular surface disease index values. Avila et al. concluded that platelet-rich plasma injections are safe and effective at improving objective and subjective dry eye parameters. This research is published in the British Journal of Ophthalmology
  • Lens autofluorescence measured with a scanning confocal biomicroscope could be used to identify patients with undiagnosed type 2 diabetes, according to research by Seren Pehlivanoglu, MD, et al. In a cross-sectional, comparative study, Pehlivanoglu and coinvestigators measured lens autofluorescence in 191 subjects (82 who had physician-diagnosed type 2 diabetes and 109 who "self-reported as normal"). In addition, they performed a full ophthalmic exam and analyzed fasting plasma glucose and glycosylated hemoglobin levels. The mean fluorescence ratio was significantly higher in diabetic subjects than those without diabetes, and there was a significant correlation between fluorescence ratio, fasting plasma glucose, and glycosylated hemoglobin. "Measuring [autofluorescence] of [the] human lens as indirect evidence of increased advanced glycation end products may [be] helpful in detecting impaired glucose metabolism," Pehlivanoglu et al. wrote. "Our results show highly significant correlation between [the] possibility of [diabetes] and [fluorescence ratio]." This research is published in the journal Clinical Ophthalmology.

  • Product news
  • Described as the first artificial intelligence mobile app for eye care providers, Fluid Intelligence (RETINA-AI, Houston) went live this week with the ability to detect macular edema and subretinal fluid on OCT scans, according to a company press release. With less than 3,000 retinal specialists in the U.S., the company's press release stated that an app like Fluid Intelligence could help healthcare professionals better assess cases that might need urgent referral. The app is currently available for purchase in the Apple App Store, and an Android version is in development.
  • LensGen (Irvine, California) earned a patent from the U.S. Patent Office for Juvene, its modular, fluid-optic shape-changing, presbyopia-correcting IOL. This lens, implanted at the time of cataract surgery, is designed to mimic natural accommodation with its shape-changing properties. It is currently considered an investigational device.

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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