EW Weekly, March 8, 2019

March 8, 2019
Volume 24 , Number 9

FDA: Class 1 recall for Raindrop Near Vision Inlay

The U.S. FDA announced this week a recall of the Raindrop Near Vision Inlay (Optics Medical). The recall stems from post-approval study data that showed an increased risk for corneal haze associated with the device. The FDA classified this as a Class 1 recall, which is its most serious type of recall. In November 2018, Optics Medical sent a letter to customers to urge them to stop implanting the Raindrop inlay in patients and to return any unused inlays to the company. Clinicians should return any Raindrop inlays to Optics Medical c/o the UPS Store, 26895 Aliso Creek Road #B, Aliso Viejo CA 92656. Patients should keep regularly scheduled appointments with eyecare providers but seek an evaluation sooner if they develop visual symptoms such as blurry vision or glare. For questions about the recall, contact Optics Medical at 949-330-6511.

Endpoints met in Phase 3 trial for teprotumumab for active thyroid eye disease

Primary and secondary endpoints were met in a Phase 3 confirmatory trial for teprotumumab (Horizon Pharma) to treat active thyroid eye disease, according to a company press release. The study met its primary endpoint, which showed meaningful improvement in proptosis in more patients treated with teprotumumab versus placebo. Nearly 83% of patients on teprotumumab had a 2 mm or more reduction in proptosis compared with 9.5% of placebo patients. Secondary endpoints were also met, and the safety profile was consistent with the Phase 2 study of the drug. The company expects to submit a Biologics License Application to the FDA by the middle of this year, according to the release. Teprotumumab has already received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA. Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor 1 receptor.

Dosing resumed in APL-2 Phase 3 program for geographic atrophy patients

Dosing with APL-2 (Apellis Pharmaceuticals) in a Phase 3 program for patients with geographic atrophy has resumed, according to a company press release. The company has two Phase 3 trials underway for geographic atrophy, called DERBY and OAKS. The company expects to have both trials fully enrolled by the end of the first quarter of 2020. In October 2018, the company voluntarily stopped dosing due to observed cases of non-infectious inflammation in patients treated from a single manufacturing lot of APL-2 intravitreal investigational material. Inflammation resolved in all patients, according to the company. The DERBY and OAKS trials are prospective, international, multicenter, randomized, double-masked, sham-injection studies enrolling 600 patients that are assessing the efficacy and safety of multiple APL-2 injections in patients with geographic atrophy secondary to age-related macular degeneration.

Autologous serum tears may help with neuropathic corneal pain

Changes in the subbasal corneal nerve plexus of patients with debilitating neurotrophic corneal pain were seen with the use of autologous serum tears, reported S. Aggarwal and coresearchers. Their retrospective case control study included 16 patients with severe neurotrophic corneal pain and no current ocular surface disease compared with 12 controls. In vivo confocal microscopy of the central cornea was performed bilaterally. Pain severity, corneal nerve density, tortuosity, reflectivity, and the presence of beading and microneuromas before and after treatment were measured. On a scale of 0 to 10, the average pain severity was 9.1. Prior to treatment, the subbasal nerves were significantly lower compared to controls, including total nerve length and total number of nerves. After treatment for an average of 3.8 months, pain severity decreased to 3.1 ( P<0.0001). In vivo confocal microscopy showed a significant improvement in total nerve length and number as well as a significant reduction in reflectivity and tortuosity. The study is published in The Ocular Surface.

Breakthrough Device Designation given to aid for concussion assessment

The FDA has issued a Breakthrough Device designation for EYE-SYNC (SyncThink), a device that can provide objective measurements to aid in concussion assessment, according to a company press release. The eye-tracking platform is currently used to help healthcare professionals evaluate visual impairments, monitor recovery, and support the rehabilitation of ocular-motor and ocular-vestibular deficits.

Register now for "Cataract Surgery in Patients with Corneal Pathology" webinar

On Wednesday, March 20 at 9 p.m. EDT, ASCRS is hosting the "Cataract Surgery in Patients with Corneal Pathology" webinar. Sponsored by the Cornea Clinical Committee, attendees will review how to evaluate and manage cataracts in patients with various corneal diseases, including anterior basement membrane dystrophy, Salzmann's nodular degeneration, keratoconus, and Fuchs' dystrophy. Surgery timing and when to consider combining surgeries will also be discussed. Join moderator Brandon Ayres, MD, panelists Marjan Farid, MD, and Elizabeth Yeu, MD, and facilitator Clara Chan, MD for this engaging and valuable session. This webinar is complimentary for ASCRS members. The cost to attend the webinar is $75 for nonmembers, or become a member of ASCRS today.

Research briefs

  • Combined amniotic membrane transplantation and medical therapy do not accelerate corneal epithelialization or affect final visual acuity in severe chemical injuries compared to conventional medical therapy, reported Medi Eslani and coresearchers. Their randomized, parallel-controlled clinical trial included 60 eyes of 60 patients with a Roper-Hall grade IV ocular chemical injury with a minimum follow-up of 12 months. Patients were randomly assigned to Group 1 (30 eyes), in which patients received topical preservative-free lubricating gels and drops, chloramphenicol, betamethasone, homatropine, oral vitamin C, and doxycycline; or Group 2 (30 eyes), which received amniotic membrane transplant on the entire ocular surface in addition to the same medical treatment as Group 1. The mean follow-up time was 20.3 months. Corneal epithelial defects improved within 72.6 days in Group 1 versus 75.8 days in Group 2 (P=.610). The mean BCVA was 2.06 logMAR versus 2.06 logMAR, respectively. There was more central corneal neovascularization in Group 1, but it was not statistically significant. The study is published in the American Journal of Ophthalmology.
  • Use of a trabecular microbypass stent (iStent, Glaukos) and cataract surgery achieved substantial, durable, and safe IOP and medication reductions, according to Tobias Neuhann, MD, and coresearchers. Their prospective, nonrandomized, consecutive case series included 65 eyes of 43 patients with open angle glaucoma. One stent was implanted after phaco by one surgeon over 4 years. Previous trabeculectomy and/or glaucoma laser surgery occurred in 38% of eyes; 68% were on two or more medications before surgery. Twenty-six eyes completed 5 years of follow-up, which is ongoing. The mean year 5 IOP reduced by 38% to a mean of 14.7 mm Hg in eyes without additional glaucoma surgery versus 23.7 mm Hg preop. A mean year 5 IOP of 18 mm Hg or lower was seen in 92% of eyes. Mean medication use was reduced to 0.5 versus 2.0 preop. The mean IOP at all postop visits was 16.0 mm Hg or lower. Safety was favorable throughout follow-up. The study is published in the Journal of Cataract & 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; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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