EyeWorld Weekly Update, December 9, 2016

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December 9, 2016
Volume 21 , Number 46

Iontophoretic treatment has positive early stage results

An iontophoretic dexamethasone phosphate treatment for ocular inflammation and pain in post-surgical cataract patients has "promising data" from the third stage of a Phase 1b/2a study, developer EyeGate Pharmaceuticals (Waltham, Massachusetts) said in a press release. Stage three of this multicenter, open-label clinical trial enrolled 30 subjects who have undergone cataract surgery with implantation of a posterior chamber IOL. Patients were divided into three cohorts wherein they received iontophoretic doses of EGP-437 at either 4.5 mA-min or 14.0 mA-min, or a placebo at 14.0 mA-min. Subjects in the EGP-437 14.0 mA-min cohort were administered treatments on day 0 (preoperative), day 1, and day 4. The other two cohorts were administered treatments on day 0 (postoperative), day 1, and day 4. Subjects who were administered 4.5 mA-min dosing (3.0 mA for 1.5 minutes) realized the greatest benefit, with 30% and 80% of patients at day 14 and day 28, respectively, achieving complete reduction or an anterior chamber cell (ACC) count of 0, compared to the placebo group where 80% of subjects had to be rescued and only 10% had an ACC count of 0 on day 28. EyeGate plans to initiate a randomized, double-masked, placebo-controlled study in the first half of 2017.

Aerie fully enrolls Roclatan's Mercury 2 Phase 3 registration trial

Patient enrollment in a second Phase 3 registration trial (Mercury 2) for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% is now complete, developer Aerie Pharmaceuticals (Bedminster, New Jersey) said in a press release. Roclatan is being developed to lower IOP in patients with glaucoma or ocular hypertension. Roclatan is a fixed dose combination of Rhopressa (netarsudil, Aerie) and latanoprost. Total patient enrollment has exceeded the 690 patients needed for this three-arm study, designed to demonstrate superiority of Roclatan solution to each of its two components, all dosed once daily in the evening, according to Aerie. Enrolled patients had maximum baseline IOPs ranging from above 20 to below 36 mm Hg. Mercury 2 is a 90-day registration trial with a topline efficacy readout expected in the second quarter of 2017.

ST266 enters Phase 2 study for allergic conjunctivitis

A novel secretome, ST266, has entered Phase 2 studies for the treatment of allergic conjunctivitis, according to developer Noveome (Pittsburgh). ST266 uses paracrine signaling and has been found to help promote cellular homeostasis, modulate inflammation and regenerate damaged cells, the company said. The Phase 2 multicenter, double-masked, randomized, placebo-controlled trial will assess the efficacy, safety, and tolerability of ST266 ophthalmic drops for the treatment of the signs and symptoms of allergic conjunctivitis. The primary endpoint of the study will measure ocular itching and conjunctival redness over time following an allergen challenge. Topline Phase 1 study data showed the compound to be well tolerated, without any drug-related adverse events.

UVB exposure associated with reduced risk of myopia

Higher ultraviolet B (UVB) radiation exposure, directly related to time outdoors and sunlight exposure, was associated with reduced odds of myopia, and exposure to UVB between ages 14 and 29 years was associated with the highest reduction in odds of adult myopia, according to a press release from the London School of Hygiene & Tropical Medicine. Astrid Fletcher, PhD, and colleagues examined the association of myopia with UVB radiation, serum vitamin D concentrations, and vitamin D pathway genetic variants, adjusting for years in education. The study included a random sample of participants 65 years and older from six study centers from the European Eye Study. Of 4,187 participants, 4,166 attended an eye examination including refraction, gave a blood sample, and were interviewed by trained fieldworkers using a structured questionnaire. After exclusion for various factors, the final study group included 371 participants with myopia and 2,797 without. The researchers found that an increase in UVB exposure at age 14 to 19 years and 20 to 39 years was associated with reduced odds of myopia; those in the highest tertile (group) of years of education had twice the odds of myopia. No independent associations between myopia and serum vitamin D3 concentrations or variants in genes associated with vitamin D metabolism were found. An unexpected finding was that the highest quintile (group) of plasma lutein concentrations was associated with reduced odds of myopia. "The association between UVB, education, and myopia remained even after respective adjustment. This suggests that the high rate of myopia associated with educational attainment is not solely mediated by lack of time outdoors," Dr. Fletcher said. "As the protective effect of time spent outdoors is increasingly used in clinical interventions, a greater understanding of the mechanisms and life stages at which benefit is conferred is warranted."

Roski Eye Institute first in California to train certified ophthalmic techs

The University of Southern California (USC) Roski Eye Institute (Los Angeles) will offer the first educational program in California, one of only 14 programs nationwide, to train certified ophthalmic technicians with its Ophthalmic Technician Education Program (OTEP) beginning January 2017, the university said in a press release. The USC OTEP "will create highly skilled allied health professionals who guide patients and families on understanding their vision conditions, ensure compliance with treatment protocols, and conduct various tests and procedures that inform ophthalmologists in the diagnosis and treatments of eye diseases and vision conditions," the university said of its 21-month program.

RESEARCH BRIEFS

  • Ultrasonic coagulation of the ciliary body is a safe and effective procedure for reducing IOP in refractory glaucoma, according to G. Giannaccare and colleagues. Their prospective, multicenter, interventional study enrolled 30 eyes (16 open-angle, 10 angle-closure and four neovascular glaucoma) of 30 patients with a mean preop IOP of 30.1±10.5 mm Hg and treated them with sequential activation of each transducer lasting 4s (group 1), 6s (group 2), or 8s (group 3). Hypotensive medications were interrupted after surgery and then prescribed only if postoperative IOP was ≥21mm Hg during follow-up visits. Patients were assessed before and 1, 7, 14, 30, 90, and 180 days after the procedure. At days 1 and 180, the mean IOP was significantly reduced (18.4±7.2 and 20.2±6.2 mm Hg, respectively; all p<0.0001). Group 3 patients (8-s ultrasound exposure time) showed a greater IOP reduction than the other two groups (-16.2±8.3 for group 3 vs. -8.8±6.6 for group 2 and -3.7±6.5 for group 1; p=0.02 and p<0.001, respectively). Qualified and complete success was achieved in 23.3% and 46.7% of patients, respectively; treatment failure was recorded in 6.6%. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • A pilot study suggests that implanting a thick endocapsular open ring is feasible and may contribute to the prevention of anterior capsule opacification (ACO) and posterior capsule opacification (PCO) after cataract surgery. Ioannis Pallikaris and colleagues prospectively evaluated 15 patients (17 eyes) who underwent cataract surgery; during the surgery, a thick endocapsular open ring (peripheral capsule reconstructor) was inserted into the capsular bag, prior to IOL implantation. Six different models of IOL were implanted. The mean follow-up period was 30±8.06 months (range: 12-36 months). At the last follow-up, mild PCO was observed in only three eyes and mild ACO in three patients. The centration of IOLs was good in all but one eye, which had a tilted IOL. The study is published in Clinical Ophthalmology.
  • Central presbyopic LASIK with corneal asphericity modulation using the monovision correction algorithm was effective and safe for presbyopia treatment, according to Yin G.H. Wang and colleagues. Their prospective cohort study assessed the effectiveness, refractive outcomes, and quality of vision of central presbyopic LASIK performed with the Custom Q algorithm (WaveLight EX500, Alcon, Fort Worth, Texas) between February 2013 and January 2015 on 138 eyes (28 men, 41 women). The median age was 53.84±4.2 years. One year after surgery, the mean binocular uncorrected distance visual acuity was -0.04±0.05 logMAR (20/20), the mean binocular uncorrected near visual acuity was 0.10±0.08 logMAR (Jaeger 2), and the mean binocular uncorrected intermediate visual acuity was -0.13±0.14 logMAR (20/20). The mean K in nondominant eyes was statistically higher than the mean K in dominant eyes (43.93±1.77 D vs. 45.85±1.47 D) (P=.002). More than 95% of patients were satisfied 3 months after surgery, and at 6 months, 100% said they would recommend the surgery. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Heidelberg Engineering (Heidelberg, Germany) introduced its OCT Angiography module for use on the Spectralis to perform non-invasive, layer-by-layer examinations of flow in the vascular networks of the retina and choroid outside the U.S., the company said.
  • OD-OS (Irvine, California) introduced the Navilas 577s Navigated Retina System that allows surgeons to perform treatments under an infrared light and without a contact lens. The system allows for laser therapy planning based on color fundus and external diagnostic images.

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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