EyeWorld Weekly Update, October 27, 2017

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October 27, 2017
Volume 23 , Number 38

Katena acquires Rhein Medical

Katena Products (Denville, New Jersey) announced the acquisition of Rhein Medical (St. Petersburg, Florida). Rhein focuses on the anterior segment surgical business, including cataract and refractive surgery, glaucoma, and corneal procedures as well as the ocular surface. "The acquisition of the Rhein Medical product line is an important addition to Katena's product portfolio," said Mark Fletcher, CEO of Katena Products. "The combination of these two renowned brands will bring internal synergies as well as offer physicians a more complete resource for handheld instrumentation."

Patient enrollment completed in Phase 2 trial of CLS-TA with Eylea for DME

Patient enrollment is now complete in the TYBEE Phase 2 clinical trial for CLS-TA (Clearside Biomedical, Alpharetta, Georgia), a proprietary suspension formulation of corticosteroid triamcinolone acetonide for suprachoroidal administration to be used with intravitreally administered aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) to treat diabetic macular edema (DME). Patient follow-up during the trial is 6 months. TYBEE is a multicenter, randomized, controlled Phase 2 trial that has enrolled 71 patients naïve to pharmacologic treatment for DME. Patients were randomized to receive a combination arm of suprachoroidal CLS-TA with intravitreal aflibercept or a control arm that will receive only intravitreal aflibercept. The primary outcome measure is mean change from baseline in best corrected visual acuity between the two study arms, according to a company press release.

Subsidiary announced for Imprimis Pharmaceuticals

Imprimis Pharmaceuticals (San Diego) filed a form 8-K with the U.S. Securities and Exchange Commission that contains a corporate presentation for its new subsidiary Surface Pharmaceuticals. Surface will focus on ocular surface disease treatments and seek U.S. Food and Drug Administration (FDA) approval for three drug candidates for up to five indications, according to an Imprimis press release. Surface is intended to be separately managed and funded outside of Imprimis. Also, Imprimis announced this month that it will make compounded cyclosporine-based formulations as a potentially lower-cost alternative to cyclosporine ophthalmic emulsion (Restasis, Allergan, Dublin, Ireland). The formulation will be packaged in a multi-use, preservative-free bottle that is patent-pending and is called Klarity Drops.

First in-human clinical trial approved for sub-retinal implant

The wireless sub-retinal implant PRIMA (Pixium Vision, Paris, France) has received authorization from the French regulatory agency Agence Nationale de Sécurité du Médicament et des Produits de Santé to begin a feasibility clinical study in patients with advanced dry age-related macular degeneration, according to a company press release. Called "Feasibility Study of Compensation for Blindness with the PRIMA System in Patients With Dry Age Related Macular Degeneration," the trial is designed to evaluate the tolerance for PRIMA and show evoked central visual perception. The study is slated to recruit five patients with an interim 6-month follow-up and a 36-month long-term follow-up. The company is also pursuing discussions with the FDA to prepare a feasibility study for PRIMA in the U.S.

ASCRS Foundation Resident Excellence Award and Research Grant applications due Dec. 31

The ASCRS Foundation will again offer 10 $1,000 Resident Excellence Awards to enable ophthalmology residents exhibiting exemplary performance to attend the ASCRS/ASOA Annual Meeting, which in 2018 will be held in Washington, D.C. The categories for consideration include research, patient care, leadership, and education. The 2018 Resident Excellence Award includes:
  • A $1,000 grant to fund travel to the ASCRS/ASOA Annual Meeting, April 13-17, 2018
  • Complimentary registration
  • Four nights of complimentary accommodations at a Washington, D.C. hotel
  • Invitations to select ASCRS leadership and social events
The application for the 2018 Resident Excellence Awards can be found at https://www.ascrsfoundation.org/education. Additionally, the foundation is accepting applications for its 2018 ASCRS Foundation Research Grant program. The foundation will award 10 $5,000 Research Grants to young, enterprising ophthalmologists (in practice and in training). Totaling $50,000, the grants are intended to fund research studies, explore new treatment options, and further exploration into all areas of eye disease and treatment. Visit https://www.ascrsfoundation.org/research for more information. The deadline for both the Resident Excellence Awards and Research Grants is Sunday, Dec. 31.

RESEARCH BRIEFS

  • Second eye cataract surgery improved visual function and quality of life beyond what first eye cataract surgery was able to provide alone in a cohort study of 328 patients, led by Nakul Shekhawat, MD. All patients were having first eye and second eye phacoemulsification at one of five Veterans Affairs centers in the U.S. In addition to ophthalmic examinations, patients had their best corrected visual acuity (BCVA) measured at 30 to 90 days. Patients also completed the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ) before and after surgery. When compared with second eyes, first eyes had a worse mean preoperative BCVA (0.55 versus 0.36 logMAR, P<0.001), greater mean BCVA improvement after surgery (-0.50 versus -0.32 logMAR, P<0.001), and slightly worse preop BCVA. Second eye surgery resulted in higher NEI-VFQ scores for almost all traditional subscales, the visual function subscale, and the socioemotional subscale when compared with first eye surgery. Although first eye surgery improved visual function scores more than second eye surgery, both first and second eye surgeries had similar improvements on socioemotional scores. The study appears in Ophthalmology.
  • Single-use dual blade goniotomy and phacoemulsification resulted in a significant and sustained IOP reduction as well as a decrease in the number of glaucoma medications needed after a 6-month follow-up, according to a prospective interventional case series led by Michael Greenwood, MD. The study included consecutive glaucoma patients who had phacoemulsification and goniotomy with the single-use dual blade. Seventy percent of the 71 eyes in the study had primary open angle glaucoma. Other diagnoses included angle closure, pigmentary, pseudoexfoliative, and normal tension glaucoma. Sixty-five percent of the eyes had mild to moderate glaucoma. Mean baseline IOP dropped from 17.4 mm Hg to 12.8 mm Hg at 6 months postop. Hypotensive medication use decreased from 1.6 to 0.9, respectively. In 39.4% of patients, blood reflux was observed. The research is published in the Journal of Cataract & Refractive Surgery.
  • Corneal stromal cells can align and create organized and purposeful tissues by the influence of substrate curvature, without the need for additional topographical cues, reported Ricardo Gouveia, and coauthors. In their research, tissues self-released from corneal templates showed an organized nanostructure that had aligned collagen fibrils; significantly higher expression of corneal stroma-characteristic markers such as keratocan and lumican; and significantly higher elastic modulus compared with planar counterparts. The curved tissues were shown to support growth, stratification, and differentiation of human corneal epithelial cells in vitro while also maintaining structural integrity and shape. The findings could help researchers better understand corneal biosynthesis mechanisms in vitro and in vivo, the authors concluded. The research appears in Advanced Biosystems.
PRODUCT NEWS
  • A new 3.3 software package and hardware for the femtosecond laser platform Victus (Bausch + Lomb, Bridgewater, New Jersey) have been given 510(k) clearance by the U.S. FDA.

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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