EW Weekly, January 11, 2019

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January 11, 2019
Volume 24 , Number 2

Phase 2 topline results announced for netarsudil in a Japanese-American population

Topline results from a pilot Phase 2 study of Rhopressa (netarsudil ophthalmic solution, Aerie Pharmaceuticals, Durham, North Carolina) in a Japanese-American population were announced by Aerie. The study took place in Japan, where the drug is not yet commercially available. The pilot study enrolled 40 Japanese and second-generation Japanese-American subjects. Ocular hypotensive activity of two different dose concentrations (0.02% and 0.04%) relative to placebo over 28 days and the ocular and systemic safety of netarsudil were evaluated. The 0.02% agent lowered IOP by a range of 5 to 5.3 mm Hg for subjects, with an average baseline of 18.3 mm Hg. The 0.04% agent lowered IOP by a range of 5.2 to 6.6 mm Hg, with an average baseline IOP of 20.2 mm Hg. In the placebo arm, the IOP was lowered by 2 to 2.5 mm Hg, with an average baseline IOP of 19.6 mm Hg. There was a statistically significant lowering of IOP in both treatment arms compared with placebo. The company expects to begin a Phase 2 clinical trial in Japan in the first quarter of this year. The new trial will be consistent with the pilot study and add a concentration of 0.01%.

Eye tracking test to detect concussion receives marketing authorization by the FDA

The U.S. Food and Drug Administration (FDA) will allow marketing of a noninvasive test to help diagnose a concussion. EyeBOX (Oculogica, New York) uses eye tracking during a 4-minute test to help clinicians evaluate patients with a suspected concussion. In the DETECT clinical trial, EyeBOX had high sensitivity to the presence of a concussion. The device is designed for use in children starting at age 5 and in adults up to age 67.

CooperVision acquires Blanchard Contact Lenses

CooperVision (Pleasanton, California) has acquired scleral lens maker Blanchard Contact Lenses (Sherbrooke, Quebec, Canada), according to a CooperVision press release. Blanchard recently introduced the OneFit MED scleral lens. The acquisition includes Blanchard entities in both the U.S. and Canada.

In-licensing of Phase 2 anti-TNF alpha antibody fragment for dry eye announced

Oculis (Lausanne, Switzerland) has entered into an agreement to in-license a topical anti-tumor necrosis factor alpha antibody that is from Novartis (Basel, Switzerland), according to an Oculis press release. Named LME 636, the compound has a profile to treat inflammatory conditions in the anterior segment, including dry eye. The compound will be renamed OCS-02. The company plans to develop OCS-02 in parallel to other ongoing pipeline programs, according to the press release.

Acquisition of Shire Pharmaceuticals by Takeda complete

Takeda Pharmaceutical (Osaka, Japan) has completed its acquisition of Shire (Dublin, Ireland), the maker of Xiidra (lifitegrast).

Two agents from EyePoint on fast track for commercial launch this quarter

Dexycu (dexamethasone intraocular suspension, EyePoint Pharmaceuticals, Watertown, Massachusetts) will commercially launch in the U.S. this quarter, according to an update from EyePoint. Dexycu is a single-dose, sustained release intracameral steroid to treat postop inflammation. It was approved by the FDA last year. Also in the first quarter of this calendar year, the company will launch Yutiq (fluocinolone acetonide intravitreal implant), which was approved by the FDA in October for continuous control of chronic, noninfectious posterior segment uveitis.

First patient treated with Oxervate for neurotrophic keratitis

The first patient has been treated with Oxervate (cenegermin-bkbj) for neurotrophic keratitis, according to a Dompé press release. The FDA approved the agent in August of last year. It is the first drug to treat neurotrophic keratitis.

Inveltys launched by Kala

Inveltys (loteprednol etabonate ophthalmic suspension, Kala Pharmaceuticals, Waltham, Massachusetts) has been launched by the company, and a specialty sales force has been hired, according to a Kala press release. Inveltys is used twice a day to treat postop inflammation and pain after ocular surgery. The agent was approved by the FDA last August.

2019 ASCRS/ASOA Annual Meeting real-time program now available

The Real-Time Program for the 2019 ASCRS/ASOA Annual Meeting* is now available. The Real-Time Program provides the most updated meeting information. You can search using keywords, or you can browse by day, ASCRS categories, ASOA tracks, session type, or speakers and authors. If you have not registered yet, you can still take advantage of the best rate by registering today. Tier One pricing ends Wednesday, February 6. Make the most of the Annual Meeting by selecting the "Annual Meeting + ASCRS Subspecialty Day" category,** which provides full access to ASCRS programming including instructional courses, symposia, and ASCRS Subspecialty Day programming. Registrants for the Annual Meeting and ASCRS Subspecialty Day will receive on-demand access to all sessions, lectures, and symposia within 48 hours.

*Must have current membership to attend the Annual Meeting.
**Does not include Skills Transfer Labs.

Research briefs

  • High-density lipoprotein (HDL) cholesterol is associated with an increased risk of AMD, according to Johanna Colijn, MD, and coresearchers, in their pooled analysis of cross-sectional data. They used 30,953 individuals over age 50 from the European Eye Epidemiology consortium and 1,530 individuals from the Rotterdam Study to analyze blood lipid measurements, genetics, medication, and other factors. Although HDL was associated with an increased risk of AMD, triglycerides were negatively associated with AMD. Having a higher HDL increased the odds of larger drusen, and higher triglycerides decreased the odds. There was statistical significance with LDL only in association with early AMD (P=0.045). It is not yet clear if systemic lipids directly influence AMD or represent lipid metabolism in the retina, the researchers concluded. The study is published in Ophthalmology.
  • Intraoperative floppy iris syndrome (IFIS) may be less common in female than male patients, but its presence in females could significantly affect the rate of intraop events and affect the final visual outcome, reported Argyrios Tzamalis, MD, and coresearchers. Their comparative, retrospective, case-control study included 3,811 cataract eyes (3,213 patients) with recorded IFIS of any severity over a 4-year period that had phaco. There was IFIS in 25 eyes (1.29%); the incidence of IFIS was higher in males. Alpha1-receptor blockers were used in 72.2% of males and in none of the females with IFIS. The rate of posterior capsule rupture was significantly higher in 7 of the 25 female IFIS cases (28%) compared with 9 (9.28%) of the 97 male IFIS cases (P=.02). Posterior capsule rupture incidence and final corrected distance visual acuity correlated with IFIS severity grade only in females (P<.001 and P=.02, respectively). The research is published in the Journal of Cataract & Refractive Surgery.
  • Medical marketing and direct-to-consumer advertising in particular increased substantially between 1997 and 2016, according to a review by Lisa Schwartz, MD, and coresearchers. They found that spending in medical marketing grew from $17.7 billion to $29.9 billion overall and that direct-to-consumer advertising increased from $2.1 billion of total spending to $9.6 billion of total spending. Direct-to-consumer prescription drug advertising grew from $1.3 billion (79,000 ads) to $6 billion (4.6 million ads, including 663,000 TV commercials), with a larger focus on biologic drugs and cancer immunotherapies. There were increases in disease awareness campaigns and laboratory tests such as genetic testing. Marketing to healthcare professionals also grew, including prescriber detailing, free samples, and direct physician payments. Regulatory oversight remains limited, the researchers added. The study appears in JAMA.

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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