EW Weekly, October 19, 2018

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October 19, 2018
Volume 24 , Number 39

FDA approves fluocinolone acetonidefor noninfectious uveitis

The U.S. Food and Drug Administration (FDA) has approved Yutiq (fluocinolone acetonide intravitreal implant, EyePoint Pharmaceuticals, Watertown, Massachusetts) to treat chronic noninfectious uveitis. Yutiq uses EyePoint's Durasert drug delivery technology. Yutiq is a non-bioerodible intravitreal microinsert in a drug delivery system that contains 0.18 mg fluocinolone acetonide, according to a company press release. The insert is designed to release consistently over 36 months. Yutiq significantly lowered recurrent uveitis flares versus sham in clinical trials, the company reported. The most common adverse reactions were cataract development and IOP increase.

NDA submitted for KPI-121 0.25% for dry eye

A New Drug Application (NDA) has been submitted to the FDA for KPI-121 0.25% (Kala Pharmaceuticals, Waltham, Massachusetts), a topical treatment that is targeted to provide temporary relief of the signs and symptoms of dry eye. The drug is to be used for 2 weeks, four times a day. KPI-121 0.25% uses the company's AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology, which contains nanoparticles with proprietary coatings that improve drug penetration and distribution in the ocular tissues, according to a Kala press release. The MPPs increased drug delivery into ocular tissues more than three-fold in preclinical studies. There are three clinical trials with about 2,000 patients to support the NDA filing. An additional Phase 3 clinical trial, STRIDE 3, is also underway, with top-line results anticipated in the fourth quarter of 2019.

Top-line results announced for dry eye treatment CyclASol

Top-line results from the ESSENCE trial have been announced for CyclASol (Novaliq, Heidelberg, Germany), a preservative-free ophthalmic solution of cyclosporine A 0.1% in EyeSol. The Phase 2B/3 pivotal, randomized, double-masked, vehicle-controlled, multicenter trial focused on the efficacy, safety, and tolerability of the agent in patients with aqueous deficient dry eye disease. The trial included 328 patients at nine sites around the U.S. The primary endpoint was analyzed at 4 weeks, with continuous dosing over 3 months. Improvement of total corneal fluorescein staining compared over vehicle was demonstrated at 4 weeks with high statistical significance (P=0.002). "The effect started as early as 2 weeks after start of treatment and was maintained over the entire duration of the study," according to a company press release.

Alcon adds additional mydriatic, cycloplegic, diagnostic, and anesthetic products

Alcon (Fort Worth, Texas) has added several mydriatic, cycloplegic, diagnostic, and anesthetic products to is offerings. The products were transferred from parent company Novartis (Basel, Switzerland). The products that are part of the portfolio include Isopto Atropine (atropine sulfate ophthalmic solution 1%) indicated for mydriasis, cycloplegia, and penalization of a healthy eye to treat amblyopia; Cyclogyl (cyclopentolate hydrochloride ophthalmic solution), used to produce mydriasis and cycloplegia; Mydriacyl (tropicamide ophthalmic solution), indicated for mydriasis and cycloplegia for diagnostic procedures; Cyclomydril (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) to produce mydriasis; Fluorescite (fluorescein injection 10%), indicated in diagnostic fluorescein angiography or angioscopy of the retina; and tetracaine hydrochloride ophthalmic solution 0.5% Steri-Unit, indicated for procedures that require a short-acting topical ophthalmic anesthetic.

Metformin could have a new use in fighting vision loss

The type 2 diabetes drug metformin could play a role one day in fighting against vision loss, according to study results published in the Proceedings of the National Academy of Sciences. Lei Xu and co-researchers discovered that metformin can also stimulate metabolism in the retinal cells. This makes these cells less susceptible to age-related macular degeneration (AMD). Researchers tested metformin in three mouse models of retinal degeneration. "The drug was able to protect photoreceptors from light damage and delay degeneration of the light-sensitive rod and cone cells in the retina," according to a press release. The idea of using metformin for AMD is potentially appealing because it is widely used and inexpensive, according to the researchers. The study was funded by Research to Prevent Blindness, the Foundation Fighting Blindness, and the National Eye Institute.

RESEARCH BRIEFS

  • Introducing cataract surgery training early in residency training significantly lowered major intraoperative complications in resident-performed cataract surgeries, according to Erika Ellis, MD, and coresearchers. The retrospective case series analyzed two classes of ophthalmology residents, one class with a late introduction of cataract surgery and the other with an earlier introduction. All cases in which residents acted as primary surgeon were included. In the late-introduction cohort, there were three residents who performed 540 cataract cases, all during the final year of residency. Among the early-introduction cohort, there were four residents who performed 780 cases beginning in the first year of residency. There were higher rates of major intraop complications in the late-introduction cohort compared with the early-introduction cohort (8.5% versus 3.1%) There were also higher rates of anterior vitrectomy (7.6% versus 2.1%). The early-introduction cohort had a stable anterior vitrectomy rate of 1% to 2% throughout training; the late-introduction cohort had a peak anterior vitrectomy rate of 12% at approximately case 20. There was a lower rate of anterior vitrectomy in the early-introduction cohort. The research is published in the Journal of Cataract & Refractive Surgery.
  • More effective strategies to prevent eye trauma in individuals age 65 and older and in children and teens is needed, according to Mustafa Iftikhar, MD, and coresearchers, who authored a retrospective cohort study that focused on eye trauma hospitalizations in the U.S. from 2001 to 2014. They used the National Inpatient Sample, which is a representative sample of all U.S. community hospitals, to determine the incidence, characteristics, and causes of primary and secondary inpatient eye trauma admissions. There were an estimated 939,608 inpatient admissions (59.3% male) during the study period. Eye trauma was a secondary diagnosis in 82.9% of patients. Primary eye trauma decreased from 3.9 to 3.0 per 100,000, but secondary diagnosis of eye trauma rose from 14.5 to 19.0 per 100,000, largely attributed to a growing number of falls in those over age 65. Orbital fracture was the most frequent diagnosis for primary trauma, followed by contusion of the eye and adnexa for secondary trauma. Primary trauma occurred more often in children and teens, African Americans, Hispanics, uninsured patients, and in those receiving Medicaid. Ophthalmology practices can play an important role in proactive risk assessment and counseling, the researchers concluded. The study appears in JAMA Ophthalmology.
  • Risk factors for an outbreak of Acanthamoeba keratitis in the U.K. from 2012 to 2014 included Oxipol disinfection, contact lenses made of group IV materials, poor contact lens hygiene, deficient hand hygiene, and the use of contacts while swimming or bathing, among other factors, according to Nicole Carnt and coresearchers. Their study focused on an increase in Acanthamoeba infections during the study time period and evaluated potential causes. Users of reusable contact lenses who had Acanthamoeba were recruited retrospectively and prospectively. Controls were reusable contact lens wearers, but they did not have Acanthamoeba. An evaluation of Acanthamoeba contamination in end-user drinking water also could help the understanding in regional variations of exposure risk, the researchers wrote. The study is published in the British Journal of Ophthalmology.

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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