EyeWorld Weekly Update, August 11, 2017

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August 11, 2017
Volume 23 , Number 27

Results announced from DEL MAR Phase 2B stage 2 trial for Luminate to treat DME

The DEL MAR Phase 2B Stage 2 trial for Luminate (Allegro Ophthalmics, San Juan Capistrano, California) met its primary endpoint when used as a sequential therapy in patients with diabetic macular edema (DME), according to a company press release. The primary endpoint was noninferiority to bevacizumab in mean change in best-corrected visual acuity at 20 weeks when Luminate was a sequential therapy or combination therapy with an anti-vascular endothelial growth factor in 80 patients with DME. "The 1.0 mg dose of Luminate in sequential therapy demonstrated visual gains equivalent at all time points to bevacizumab monotherapy and again showed 12-week durability after the completion of three loading doses," the company reported. The results with Luminate occurred after one treatment of 1.25 bevacizumab followed by three 1.0 mg Luminate injections at weeks 1, 4, and 8 and then 12 weeks off treatment, compared with 5 injections every 4 weeks with bevacizumab. The drug was well tolerated and did not have any drug toxicity or ocular inflammation.

Pivotal Phase 3 PEACHTREE trial enrollment completed for CLS-TA

Enrollment is complete for the pivotal Phase 3 PEACHTREE trial for CLS-TA for suprachoroidal administration (Clearside Biomedical, Alpharetta, Georgia) to treat macular edema associated with noninfectious uveitis. The suspension from Clearside is a formulation of the corticosteroid triamcinolone acetonide. PEACHTREE is a randomized, masked, sham-controlled trial with 160 patients with macular edema associated with noninfectious uveitis. The primary outcome measure is based on the improvement in best-corrected visual acuity (BCVA) over the trial's 6-month duration. Top-line results from the clinical trial are expected in the first quarter of 2018, according to the company. Executives at Clearside believe PEACHTREE will be the only Phase 3 clinical trial needed to support the New Drug Application (NDA) for CLS-TA.

Complete Response Letter received from the FDA for latanoprostene bunod

Valeant Pharmaceuticals (Laval, Quebec) has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the NDA for latanoprostene bunod ophthalmic solution 0.024%, which is an eyedrop that is slated to lower IOP in patients with open-angle glaucoma (OAG) or ocular hypertension. The letter refers to a Current Good Manufacturing Practice inspection at the Bausch + Lomb manufacturing facility in Tampa, Florida. However, the FDA did not state any efficacy or safety concerns or indicated additional trials needed for the approval of the NDA. Valent will work closely with the FDA to determine next steps, according to a company press release.

U.S. News & World Report names top hospitals for ophthalmology

U.S. News and World Report announced its annual list of top hospitals within adult ophthalmology. Bascom Palmer Eye Institute, Miami, topped the list for the 14th year in a row. Rounding out the top five for adult ophthalmology were Wills Eye Hospital, Thomas Jefferson Hospital, Philadelphia (#2); Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore (#3); Massachusetts Eye and Ear Infirmary, Massachusetts General Hospital, Boston (#4); and Stein and Doheny Eye Institutes, UCLA Medical Center, Los Angeles (#5).

RESEARCH BRIEFS

  • Glaucoma drainage devices are used more frequently nowadays, while the use of trabeculectomy has concurrently decreased in the past 20 years, according to a study from Kateki Vinod, MD, and coresearchers. The purpose of their study was to assess surgical practice patterns among members of the American Glaucoma Society. They found that among the 252 survey participants, phacoemulsification was the preferred surgical approach in 44% of patients with primary OAG and visual significant cataract, followed by phaco combined with trabeculetomy with mitomycin C (MMC; 24%), with microinvasive glaucoma surgery (22%), and with a glaucoma drainage device (9%). In 1996, trabeculectomy was selected most often to surgically manage glaucoma in eight of eight clinical settings, but in 2016, a glaucoma drainage device was preferred in seven of eight clinical settings. The study appears in the Journal of Glaucoma.
  • A higher risk of haze is associated with hyperopic and large myopic or astigmatic corrections, but longer MMC application may help prevent haze, according to Igor Kaiserman, MD, MSc, MHA, and coresearchers. Their retrospective study of PRK with MMC included 7535 eyes; patients with a history of corneal pathology or surgery were excluded. Haze incidence, onset time, and corneal haze severity were the main outcome measures. The incidence of haze was 2.1% in eyes with high myopia compared with 1.1% in eyes with low to moderate myopia and 3.5 times higher in eyes with high astigmatism compared with low astigmatism. The overall incidence of haze was higher in eyes treated for hyperopia (10.8%) compared with myopia (1.3%). The study is published in the journal Cornea.
  • Patients with OAG were more likely to experience a stroke compared with patients who did not have OAG, and the risk was particularly higher in older adults and males, according to a new retrospective study. Led by Tyler Hyungtack Rim, researchers conducted a score-matched cohort study using the Korean National Health Insurance Service database. Over a 10-year follow-up from after OAG diagnosis, OAG was associated with an increased incidence of stroke (HR = 1.20); hypertension, diabetes, chronic renal failure, atrial fibrillation, hyperlipidemia, older age, and male sex also increased the risk. Although other studies have found an association between stroke and OAG, there is still a lack of longitudinal studies in large populations, the researchers reported. The study appears in the British Journal of Ophthalmology.
  • There was less IOL misalignment with digital marketing compared with manual marking during cataract surgery, according to Valentin S.C. Webers, MD, and coresearchers. However, this did not result in a better uncorrected distance visual acuity or lower residual refractive astigmatism. Researchers compared accuracy of IOL alignment with the Verion Image-Guided System (Alcon, Fort Worth, Texas) in eyes with a regular corneal astigmatism of at least 1.25 D that required cataract surgery and toric IOL implantation. Patients were randomly assigned to the image-guided or manual marking group. Among 36 eyes (24 patients), the mean toric IOL misalignment was significantly less in the image-guided group than the manual group at both 1 hour (1.3 degrees versus 2.8 degrees) and 3 months (1.7 degrees versus 3.1 degrees). The mean residual refractive cylinder was -0.36 D and -0.47 D in the image-guided and manual groups, respectively. The research appears in the Journal of Cataract & Refractive Surgery.

PRODUCT NEWS PRODUCT NEWS PRODUCT NEWS

  • The Stellaris Elite (Bausch + Lomb) vision enhancement system for retina surgery has been launched in the U.S. The system has multiple enhancements and the ability to integrate future technologies, including the Vitesse hypersonic vitrectomy system. Stellaris Elite has various vitrectomy cutters operating up to 7,500 cuts a minute.
  • The epithelial thickness mapping software from Optovue (Fremont, California) has been cleared by the FDA. The epi-mapping is the only FDA-cleared product to provide corneal epithelia and stroma measurements that help diagnose, document, and manage adult ocular health and diseases, according to a company press release.

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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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