EyeWorld Weekly Update, April 20, 2018

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April 20, 2018
Volume 24 , Number 13

Reduction in unmedicated IOP in IDE pivotal data trial for iStent inject

The iStent inject Trabecular Micro-Bypass System (Glaukos, San Clemente, California) led to a significant reduction in unmedicated diurnal IOP in patients undergoing cataract surgery, according to 2-year U.S. Investigational Device Exemption (IDE) pivotal trial data. The prospective, randomized, multicenter trial included 387 subjects randomized to the iStent inject along with cataract surgery and 118 subjects randomized to cataract surgery only. Subjects were followed through 24 months with annual medication washouts, according to a Glaukos press release. At 24 months, 75% of the iStent inject cohort had a 20% or larger reduction in unmedicated IOP compared with 62% in the cataract-only cohort. The mean unmedicated IOP reduction was 6.9 mm Hg for the iStent inject cohort compared with 5.4 mm Hg for the cataract-only cohort. The iStent inject has the same fluidic method of action as the first-generation iStent Trabecular Micro-Bypass Stent, according to the company. The iStent inject is not yet approved in the U.S. but is commercially available in other countries. Glaukos submitted a premarket approval application for it to the U.S. Food and Drug Administration (FDA) in December. In other Glaukos news, the company announced that it has filed a patent infringement lawsuit against Ivantis (Irvine, California), alleging that the Hydrus Microstent infringes on Glaukos patents relating to certain Glaukos' core glaucoma technologies. The suit was filed in the U.S. District Court for the Central District of California, Southern Division.

12-month results released comparing MIGS devices Hydrus and the iStent

Twelve-month results comparing the Hydrus Microstent to the iStent Trabecular Micro-Bypass Stents found that 47% of eyes in the Hydrus Microstent group were medication-free compared with 24% of eyes in the two iStent group, according to research from Ivantis. Use of medication decreased on average by 1.6 medications (61%) in the Hydrus group compared with one medication (37%) in the two iStent group. A 20% IOP reduction occurred in 73% of patients receiving the Hydrus compared with 47% of the two iStent patients. The results are from COMPARE, the first prospective, multicenter randomized trial comparing the two devices to treat open angle glaucoma in a standalone procedure, according to an Ivantis press release. The trial included 152 patients with mild to late moderate glaucoma and took place at 12 centers in eight countries outside of the U.S. It was designed to be a head-to-head comparison of devices without the confounding effect of cataract surgery, according to Ivantis.

Marketing permitted for IDx-DR for detection of diabetic retinopathy in primary care

The FDA has granted a De Novo request from IDx (Coralville, Iowa) to market its IDx-DR, an artificial intelligence-based diagnostic system for the autonomous detection of diabetic retinopathy. It is the first autonomous, artificial intelligence-based diagnostic system authorized for commercialization by the U.S. FDA, according to a press release from IDx-DR. The system can be used to provide an immediate assessment for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting, the company reported. Information generated by the exam and interpretation allow primary care providers to counsel patients about follow-up care while they are still in the office.

Additional Phase 3 trial required for RGN-259 for dry eye

The FDA is asking for an additional Phase 3 trial to be completed for the New Drug Application submission of RGN-259 (RegeneRx Biopharmaceuticals, Rockville, Maryland). The additional Phase 3 trial would follow the company's completion of ARISE-2, also a Phase 3 trial. All safety data from ARISE-1 and ARISE-2 were accepted by the FDA, and the company's chemistry and manufacturing control plans for the drug substance and product were considered complete and acceptable, according to a company press release.

FDA issues guidance for resubmission of the EyeGate Ocular Bandage Gel

The U.S. FDA has provided guidance to EyeGate Pharmaceuticals (Waltham, Massachusetts) regarding its amended IDE application for a second pilot study of the EyeGate Ocular Bandage Gel, which is under development to accelerate reepithelialization of large corneal epithelial defects in patients having PRK. The letter from the FDA identified four deficiencies in the company's submission and requested more information on the manufacturing processes associated with the EyeGate Ocular Bandage Gel, according to a company press release. EyeGate anticipates targeting a second amendment to the IDE application in July of this year. If the next amendment is approved by the FDA, the company would look to initiate the product's second pilot study in PRK patients later in the third quarter.

RESEARCH BRIEFS

  • Patients with dry eye disease who received 3,000 mg of omega-3 fatty acid supplements for 12 months did not have significantly better outcomes than those assigned to receive placebo in the multicenter, double-blind Dry Eye Assessment and Management (DREAM) study. Patients received a daily oral dose of fish-derived omega-3 acids or an olive oil placebo. The primary outcome was the mean change from baseline in the Ocular Surface Disease Index (OSDI) score at 6 and 12 months. There were 349 patients in the active supplement group and 186 in the placebo group. The mean OSDI score did not differ significantly between the two groups. There also were no significant differences between the two groups in terms of conjunctival staining score, corneal staining score, and Schirmer's test result. There was an 85.2% rate of adherence to treatment in the active supplement group. The study appears in the New England Journal of Medicine.
  • Compared with other specialties, ophthalmology has a relatively low number of malpractice claims reported and has less spending on average indemnity and defense, according to a retrospective analysis of closed medical professional liability (MPL) claims, led by Atalie Thompson, MD. Researchers found 90,743 MPL claims, of which 2.6% of closed claims and 2.2% of paid claims were against ophthalmologists. Only 24% of closed claims against ophthalmologists resulted in payment, the authors reported. Two-thirds were dropped, withdrawn, or dismissed. There was a verdict favorable toward the ophthalmologist in 90% of claims. The costliest operative procedures among the claims were cataract and cornea procedures. The average indemnity for corneal procedures was higher than vitreoretinal procedures, oculoplastic procedures on the eyelid, and orbit and eyeball procedures. The study is published in Ophthalmology.
  • In a study comparing visual outcomes with four IOLs, the extended range of vision IOL and the +2.5 D multifocal IOL had markedly better intermediate visual restoration after cataract surgery compared with the monofocal IOL and the +3.0 D multifocal IOL, according to Emilio Pedrotti, MD, and coresearchers. The study included patients with bilateral cataract surgery implanted with a Tecnis (Johnson & Johnson Vision, Santa Ana, California) one-piece monofocal (30 patients), Tecnis Symfony extended range of vision IOL (55 patients), ReSTOR (Alcon, Fort Worth, Texas) +2.5 D multifocal IOL (50 patients), and the ReSTOR +3.0 D multifocal IOL (50 patients). There was also better spectacle independence with the +2.5 D multifocal IOL and extended range of vision IOL. The research appears in the Journal of Cataract & Refractive Surgery.
PRODUCT NEWS
  • LENSAR (Orlando, Florida) received 510(k) clearance for the LENSAR Laser System's new Streamline IV, which expands the platform's capabilities to include the creation of corneal pockets and flaps used to treat presbyopia.
  • TrueTear (Allergan, Dublin, Ireland) has been released to temporarily increase tear production during neurostimulation in adult patients. It is the first and only FDA-cleared device of its kind, according to a company press release. TrueTear is a handheld neurostimulation device with disposable tips inserted into the nasal cavity to induce the production of natural tears.

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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