EW Weekly, February 24, 2017

February 24, 2017
Volume 22 , Number 8

FDA accepts Dextenza NDA

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for Dextenza (dexamethasone insert) 0.4 mg for the treatment of ocular pain after ophthalmic surgery from developer Ocular Therapeutix (Bedford, Massachusetts). Dextenza is administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days, the company said. Ocular Therapeutix had resubmitted its NDA in response to a complete response letter received from the FDA in July 2016, which identified items pertaining to deficiencies in manufacturing process and controls. The FDA determined that the NDA resubmission is a complete response and designated the resubmission as a Class 2 review, with a target action date under the Prescription Drug User Free Act of July 19, 2017, for the potential approval of Dextenza, according to a press release from Ocular Therapeutix.

Patient enrollment in pivotal phase is complete for U.S. trial for iStent Supra

Patient enrollment is complete in the pivotal phase of the U.S. FDA Investigational Device Exemption trial for the iStent SUPRA Suprachoroidal Micro-Bypass Stent, according to a press release from developer Glaukos (San Clemente, California). The iStent SUPRA trial is a prospective, randomized clinical trial at 36 sites with 505 subjects who have mild to moderate primary open-angle glaucoma and cataracts. Subjects were randomized for the iStent SUPRA with cataract surgery or cataract surgery alone. The study's primary outcome measure at 24 months is a 20% or higher reduction in IOP compared to baseline. The trial results are expected to form the basis of Glaukos' future Pre-Market Approval submission to the FDA. The iStent SUPRA aims to reduce IOP by accessing the eye's suprachoroidal space, an area that is responsible for about 20% of the aqueous fluid outflow. The iStent SUPRA is already approved for marketing in Europe and other countries around the globe outside of the U.S. In other Glaukos news, L. Jay Katz, MD, FACS, has joined the company as chief medical officer. Dr. Katz is currently director, Glaucoma Service, Wills Eye Hospital, and professor of ophthalmology, Jefferson Medical College, Thomas Jefferson University, both in Philadelphia.

Dropless Therapy and LessDrops Formulations to become available to all customers

Imprimis Pharmaceuticals (San Diego) has begun to ship its core sterile ophthalmic medications, Dropless Therapy injectable and LessDrops, to select customers from its FDA-registered outsourcing facility in New Jersey, according to a company press release. Currently, customers can purchase Dropless and LessDrops in 20-unit boxes without a patient-specific prescription. However, to facilitate expected growth, the company's new integrated order and fulfillment system has functionality similar to an online shopping cart that moves orders right to the facility's fulfillment center, according to the press release. The medications currently have more than 1,450 customers and have been part of 600,000 cataract and refractive surgeries since mid-2014, the company reported.

Licensing agreement reached between Valeant and EyeGate for EGP-437

Valeant Pharmaceuticals (Laval, Quebec) and EyeGate Pharmaceuticals (Waltham, Massachusetts) have reached a global licensing agreement through which EyeGate has granted a Valeant subsidiary the exclusive commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product. EGP-437 is used for the treatment of postoperative pain and inflammation in ocular surgery patients. "We believe the product has significant potential in the market as part of our Bausch + Lomb [Bridgewater, New Jersey] business and applaud EyeGate for a remarkable job in advancing the product's development in both uveitis and cataract surgery," said Joseph C. Papa, chairman and CEO of Valeant, in a press release.

New drug submission forIluvien filed in Canada

A New Drug Submission (NDS) for Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg has been accepted for review by Health Canada, according to Alimera Sciences (Atlanta) and Knight Therapeutics (Montreal). Iluvien is a sustained release intravitreal implant from Alimera and is approved in the U.S. to treat diabetic macular edema patients previously treated with corticosteroids and who did not have a clinically significant rise in IOP. The NDS was filed by Knight Therapeutics, a Canadian specialty pharmaceutical company. The two companies signed an agreement in 2015 that gives Knight the exclusive right to distribute Iluvien in Canada.


  • Significant predictors of more symptoms than signs of dry eye were found in patients who had a chronic pain syndrome, atopic disease, a known allergy, depression osteoarthritis, or who used antihistamines or anti-depressants, according to research from Jelle Vehof, MD, PhD, and coauthors. Their study focused on the discordance between symptoms and signs in dry eye and included 648 patients with dry eye from a dry eye clinic patient cohort in the Netherlands. Predictors of fewer symptoms than signs were increased age, the presence of Sjögren's disease, and graft-versus-host disease. The research results can help better assess dry eye patients in clinical practice, the authors concluded. The study is published in Ophthalmology.
  • Using the National Eye Institute Visual Function Questionnaire-25, researchers found that trabeculectomy versus tube shunt surgery had a similar impact on patient-reported visual quality of life (QoL), according to Aachal Kotecha, PhD, and coauthors. They were comparing vision-specific QoL outcomes in the Tube Versus Trabeculectomy study. Patients were 18 to 85 years old and seen at 17 clinical centers. They all had medically uncontrolled glaucoma and previous cataract and/or glaucoma surgery. Patients had either a tube shunt or trabeculectomy with mitomycin C. Researchers found no significant differences in composite scores between the two treatment groups, nor did they find a significant change in scores over time. The research appears in the American Journal of Ophthalmology.
  • In patients with open-angle glaucoma (OAG) and ocular hypertension who used twice-daily inhaled fluticasone propionate, there was no clinically significant increase in mean IOP compared with inhaled placebo. The randomized, double-masked, placebo-controlled trial focused on 22 adults with well-controlled OAG or ocular hypertension. Participants were randomized to receive a 6-week course of fluticasone propionate or saline placebo. There were no statistically significant differences between groups at baseline or at week 6, and adherence was higher than 80% for all participants. One patient in the steroid group met the study's secondary endpoint of a greater than 20% elevation in IOP. The study was led by Edward B. Moss, FRCSC, MD, and is published in the Journal of Glaucoma.
  • High overall quality of vision was seen when implanting rotationally asymmetric multifocal IOL in a combination of superotemporal placement of the near segment (+2.00 D add) in the dominant eye and inferonasal placement of the near segment (+3.00 D add) in the fellow eye. Researchers, led by Richard N. McNeely, BSc, focused on how IOL placement pattern affected visual performance. The retrospective comparative case series included 180 patients (360 eyes). Group 1 had bilateral SBL-3 IOLs (Lenstec, St. Petersburg, Florida), and Group 2 received bilateral Lentis Mplus LS-312 MF30 IOLs (Oculentis, Berlin, Germany). Patients in both Group 1 and 2 had near segments placed inferonasally. Group 3 received a Lentis Mplus LS-312 MF20 IOL in the dominant eye, but with the near segment positioned superotemporally, and a Lenstec SBL-3 IOL positioned inferonasally in the fellow eye. No significant difference was found between the groups in binocular uncorrected distance, intermediate, or near visual acuity. The groups did have a significant difference in quality of vision, with Group 3 reporting a significantly better quality. The study is published in the Journal of Cataract & Refractive Surgery.

  • 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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