EW Weekly, November 22, 2019

Aerie acquires Avizorex Pharma
Aerie Pharmaceuticals has acquired the Spanish firm Avizorex Pharma, which specializes in developing therapeutics for dry eye disease. Earlier this year, Avizorex completed a Phase 2a study with AVX-012, its lead product candidate. The active ingredient is AVX-012, a selective agonist of the TRPM8 ion channel, a cold sensor, and an osmolarity sensor that regulates ocular surface wetness and blink rate, according to a press release from Aerie. TRPM8 agonists could have the potential to restore tear film instability and reduce dry eye-related discomfort, Aerie reported. A larger Phase 2b study of AVX-012 is planned for late next year. As part of the agreement between the two companies, Aerie also will acquire the rights to other compounds that target TRPM8. The acquisition is slated to close by the end of this year.

FDA approves MiSight contact lens to slow myopic progression in children
The U.S. FDA has approved MiSight (CooperVision), the first contact lens indicated to slow down the progression of myopia in children ages 8–12 years old. Approval data comes from a prospective clinical trial at four clinical sites as well as real-world evidence. In a randomized controlled clinical trial of 135 children ages 8–12, myopic progression was shown to be less in those wearing the MiSight lenses compared with those wearing conventional contact lenses. There also was less change in the axial length in patients who wore the MiSight lenses. CooperVision is required to do a post-market study of MiSight to further evaluate safety and efficacy. MiSight is a daily, disposable contact lens.

European Commission approves Rhokiinsa
The European Commission granted Rhokiinsa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals) marketing authorization, according to a company press release. Approved by the U.S. FDA in 2017 as Rhopressa, the drug is meant to reduce IOP in adults with primary open-angle glaucoma or ocular hypertension. “The receipt of an EC marketing authorization for Rhokiinsa is an important milestone for Aerie as it once again demonstrates the potential value of Aerie’s netarsudil franchise at an international level,” Vicente Anido, Jr., PhD, Aerie chairman and CEO, said in a press release statement. He also said it sets the stage for future approval in Europe of Roclanda (FDA-approved as Rocklatan in the U.S.), a fixed-dose combination of netarsudil and latanoprost.

Second pivotal clinical trial of Zimura in geographic atrophy initiated
IVERIC bio. started to identify U.S. and international clinical trial sites for its second pivotal clinical trial in geographic atrophy secondary to dry AMD for avacincaptad pegol (Zimura), according to a company press release. This is the only additional pivotal, randomized, double-masked, sham-controlled clinical trial that company leaders believe is needed to support regulatory approval, provided its safety and efficacy profile remains consistent. In a previously announced Phase 2b trial, Zimura met its prespecified primary efficacy endpoint and reached statistical significance in geographic atrophy secondary to AMD.

Study: Deep learning algorithm detects referable glaucoma
A deep learning algorithm using fundus images was able to detect referable glaucomatous optic neuropathy with higher sensitivity and comparable specificity of eyecare providers, according to Sonia Phene, BS, and coresearchers. The study used an algorithm developed with a retrospective dataset of 86,618 images that were analyzed for glaucomatous optic nerve head features and referable glaucomatous optic neuropathy by 43 graders. The algorithm was validated with three datasets: dataset A (18.1% referable), with images adjudicated by a panel of glaucoma specialists; dataset B (9.2% referable), with images from a diabetic teleretinal screening program; and dataset C (81.7% referable), with images from a glaucoma clinic. The area under the receiver operating characteristic curve for the algorithm for referable glaucomatous optic neuropathy was 0.945 in dataset A, 0.855 in dataset B, and 0.881 in dataset C. The most crucial features related to referable glaucomatous optic neuropathy for both the specialists and the algorithm were presence of vertical cup-to-disc ratio of 0.7 or more, neuroretinal rim notching, retinal nerve fiber layer defect, and bared circumlinear vessels. The study is published in Ophthalmology.

ELT Sight acquires MLase AG Excimer Laser System assets and IP
Sight acquired the IP and assets of the MLase AG excimer ophthalmic laser system for glaucoma surgery, according to an ELT Sight press release.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member. Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • Medical residents were able to safely and efficaciously perform Baerveldt glaucoma drainage device (Johnson & Johnson Vision) implantation, reported Adam Rothman, MD, in a retrospective study. Researchers reviewed Baerveldt implantation and up to 1 year of postop management in a resident-run clinic. Failure was defined as two consecutive visits starting at postop month 3 with an IOP of 5 mm Hg or less, an IOP greater than 21 mm Hg, or less than a 20% IOP reduction from baseline. Other indicators of failure included reoperation for glaucoma or loss of light perception. Among the 48 eyes in the study, the mean IOP at baseline was 23.1 mm Hg; the mean number of medications was 3.7. The mean postop IOP was 20.5 mm Hg, 14.3 mm Hg, 16.7 mm Hg, and 13.0 mm Hg at postop day 1, postop week 1, and postop months 1 and 12, respectively. The mean number of medications decreased to 2.8 by month 12. Seventeen percent of patients failed on the implant, at a mean of 9.2 months. No patients had additional glaucoma surgical interventions or lost light perception. The study is published in the Journal of Glaucoma.
  • When comparing preservative-containing and preservative-free prostaglandin analogue formulations on the ocular surface, Jun Young Ha and coresearchers found that preservative-containing formulations led to more ocular discomfort, a poorer ocular surface, and more severe meibomian gland loss compared with the preservative-free formulations. Their retrospective study included 80 treatment-naïve patients with open-angle glaucoma (OAG) and 40 healthy controls. The OAG patients were randomized into groups to use their respective formulation for 12 months. At baseline, patients in both groups had similar ocular surface and meibomian gland parameters. At the 12-month visit, the preservative-containing prostaglandin group showed more severe Ocular Surface Disease Index scores, shorter tear film breakup time, greater ocular surface staining, and worse meibomian gland parameters. The preservative-free group had worse meiboscores, meibum scores, and severe ocular surface staining scores compared with the control group (all P<0.05). Although both types of prostaglandins led to meibomian gland damage, preservative-free formulations are advisable in patients with preexisting or concomitant ocular surface disease or meibomian gland disease, the researchers concluded. The study is published in Chonnam Medical Journal.
  • A prospective, cross-sectional study of patient-reported, long-term quality of vision after SMILE identified some of the factors associated with a higher risk for visual disturbances, Valerie Schmelter, MD, and coresearchers reported. The researchers used a clinically validated, 30-item instrument to obtain a quality of vision score related to symptom frequency, severity, and bothersome. Patient subgroups were stratified by baseline characteristics, such as age and treatment parameters, along with refractive outcomes and visual outcomes. A total of 394 eyes were included from 197 patients. The quality of vision scores for symptom frequency, severity, and bothersome were 34.63, 29.60, and 24.56, respectively. Worse quality of vision scores were associated with patients who had a preop binocular corrected distance visual acuity of 20/12.5 or better, lost a line or more of uncorrected distance visual acuity compared with preop corrected distance visual acuity, were over age 40, and those who had inadvertent anisometropia of more than 0.375 D. These prognostic factors should be discussed in advance with patients seeking SMILE procedures, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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