EyeWorld Weekly Update, June 23, 2017

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June 23, 2017
Volume 23 , Number 22

Indication for mydriasis in ophthalmic surgery removed from Adrenalin

Par Pharmaceutical (Chestnut Ridge, New York) announced a new formulation of Adrenalin (epinephrine) injection 1-ml single-use vials. With the addition of the inactive ingredient, tartaric acid, the new formulation is not approved for intraocular use, and the indication of induction and maintenance of mydriasis during intraocular surgery has been removed from the Prescribing Information. The updated formulation of Adrenalin contains tartaric acid to improve product stability, and the safety of tartaric acid in the levels present in Adrenalin has not been established for intraocular use or intracameral injection.

Brolucizumab shows visual gains in nAMD patients in Phase 3 trials

Two pivotal Phase 3 studies showed that brolucizumab 6 mg (RTH258, Novartis, Basel, Switzerland) met its primary and secondary endpoints for the treatment of neovascular age-related macular degeneration (nAMD). Brolucizumab 3 mg was also evaluated in one of the trials and met its endpoints. The two Phase 3 studies, called HAWK and HARRIER, had more than 1,800 patients with AMD at 400 centers around the globe. Efficacy endpoints included non-inferiority of RTH258 to aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) in mean change in best corrected visual acuity from baseline to week 48 and average mean change between weeks 36 and 48. The agent was generally well tolerated, had non-systemic adverse event rates comparable to aflibercept, and demonstrated long-lasting efficacy versus aflibercept dosed every 8 weeks. Fifty-seven percent of patients in the HAWK trial and 52% in HARRIER received treatment every 12 weeks after the loading phase through week 48. The company plans to complete its pharmacokinetic study with the final manufacturing process to enable regulatory filing in 2018, according to a company press release.

Acute conjunctivitis treatment not always accurate

Fifty-eight percent of patients with acute conjunctivitis receive antibiotic drops that are not necessary, according to a study led by Nakul Shekhawat, MD. About 20% of patients received an antibiotic/steroid combination therapy that can make the infection last longer or worsen it. The study included 300,000 patients diagnosed with acute conjunctivitis over a 14-year period. The odds of filling the prescription depended more on a patient's socioeconomic status than the patient's risk for developing a more serious eye infection, according to a press release about the study. Primary care providers were most likely to diagnose pink eye (83%) among the cases in the study. Those diagnosed by a primary care provider or urgent care provider were two to three times more likely to fill prescriptions for antibiotic eye drops than patients who were diagnosed by an ophthalmologist. The study is published in Ophthalmology.

Treatment for macular telangiectasia effective in Phase 2 study

Twenty-four months of treatment with NT-501 (Neurotech, Cumberland, Rhode Island) delivering ciliary neurotrophic factor was beneficial in patients with macular telangiectasia type 2 in a Phase 2 multicenter, randomized clinical trial. The trial included 67 patients (99 eyes) at eight sites across the U.S. and three in Australia. Eyes received the NT-501 implant or a sham procedure. The primary endpoint of change in the ellipsoid zone from baseline to month 24 was measured by spectral domain OCT. The trial showed a statistically significant reduction in the progressive loss of photoreceptors in treated versus untreated eyes. NT-501 was generally well-tolerated, and no implant had to be removed during the trial. The agent NT-501 uses Neurotech's proprietary encapsulated cell therapy platform to customize and deliver therapeutic molecules to the back of the eye for retinal disease, according to a company press release. The company plans to begin its Phase 3 program by the end of this year, and the company has another program for NT-501 underway for glaucoma.

Academic performance strong in children with higher macular pigment optical density

Higher levels of macular pigment optical density, an indicator of retinal xanthophylls and a correlate of brain lutein, are associated with better cognitive function among children, according to Sasha Barnett and co-researchers. The 56 children in their study (ages 8 and 9 years) had their macular pigment optical density measured via heterochromatic flicker photometry. Academic performance was measured with the Kaufman Test of Educational Achievement. Food records were used in a subsample to measure the dietary intake of xanthophylls and brain lutein. Overall academic achievement and written language composite standard scores improved when more xanthophylls and lutein were present. The research appears in Nutritional Neuroscience.

RESEARCH BRIEFS

  • Patients with both type 2 diabetes and diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR) are at a higher risk for incident cardiovascular disease, according to Jing Xie, PhD, and coauthors. Their work reviewed the relationship between these factors in studies that have appeared in English-language publications and identified 7,604 people who were part of eight prospective population-based studies that had data on photographic-based DR grading, follow-up visits, and well-defined incident cardiovascular disease endpoints. They found DME present in 4.6% of patients with type 2 diabetes and in 7.4% of people with PDR. Of 1,203 incident cardiovascular events, 916 were coronary heart disease cases over a mean follow-up of 5.9 years. Those with DME or PDR were more likely to have incident and fatal cardiovascular disease. The study appears in JAMA Ophthalmology.
  • Adults with atopic dermatitis are at a significantly greater risk for the development of conjunctivitis, keratitis, and keratoconus compared with the general population, according to Jacob Thyssen, MD, and coauthors. The study focused on 5,766 and 4,272 adults with mild and severe atopic dermatitis, respectively. The hazard ratio of conjunctivitis was 1.48 in mild atopic dermatitis and 1.95 in severe atopic dermatitis. The hazard ratio of keratitis was 1.66 for mild atopic dermatitis and 3.17 for severe atopic dermatitis. For keratoconus, the hazard ratio was 10.01 for severe atopic dermatitis. The authors said there is no other large-scale epidemiologic data to their knowledge regarding the prevalence of ocular comorbidities in adults with atopic dermatitis. The study is published in the Journal of the American Academy of Dermatology.
  • During the 20 years following cataract surgery, corneal astigmatism continues to change toward against-the-rule, according to Ken Hayashi, MD, and co-researchers. In their retrospective case study, they measured preoperatively, at baseline, and at 10 and 20 years after baseline in 74 eyes. All patients had phacoemulsification with a horizontal scleral incision more than 21 years previously; the study also had a group of 68 eyes that had no surgery. The mean vertical/horizontal change in corneal astigmatism between baseline and 20 years was -0.64 D in the group that had surgery and -0.49 D in the patients who had no surgery. The mean corneal astigmatism and oblique change values were not significantly different between baseline and 10 years and 10 and 20 years. The trend toward against-the-rule astigmatism was also similar in eyes that did not have surgery. The study appears in the Journal of Cataract & Refractive Surgery.
  • Although both small incision lenticular extraction (SMILE, Carl Zeiss Meditec, Jena, Germany) and wavefront-guided LASIK are efficacious and safe for low and moderate myopia, wavefront-guided LASIK allows for a more predictable outcome and better aberrometric control, according to Mounir Khalifa, MD, and coauthors. The prospective comparative study included 110 eyes with low and moderate myopia (spherical equivalent less than or equal to 6.0 D). During a 6-month follow-up, visual, refractive, aberrometric, and contrast sensitivity outcomes were evaluated. The mean efficacy index was 0.92 ± 0.11 and 1.12 ± 0.17 in the SMILE and wavefront-guided LASIK group, respectively. The postop spherical equivalent was within ± 0.50 D in 81.54% and 98% of eyes in the SMILE and LASIK groups, respectively. There was a higher increase in higher order and coma root mean square and a higher decrease in contrast sensitivity for 6, 12, and 18 cycles/degree after SMILE. The research is published in the Journal of Refractive Surgery.

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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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