EW Weekly, January 18, 2019

January 18, 2019
Volume 24 , Number 3

Supplemental New Drug Application filed for Dextenza

Ocular Therapeutix (Bedford, Massachusetts) has filed a supplemental New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert). The supplemental NDA seeks to expand Dextenza's current indications to include the treatment of ocular inflammation after ophthalmic surgery, according to a company press release. The FDA review is slated for completion in the second half of 2019, Ocular Therapeutix reported. Dextenza is currently approved by the FDA as an intracanalicular insert that delivers dexamethasone to treat postop ocular pain for up to 30 days with a single administration. It was approved for this use in November 2018.

Investigational NDA for AR-1105 reviewed and accepted by FDA

The FDA has reviewed and accepted the NDA for AR-1105 (dexamethasone intravitreal implant, Aerie Pharmaceuticals, Durham, North Carolina), which allows drug maker Aerie to start studies in humans for the treatment of macular edema due to retinal vein occlusion, according to a company press release. Aerie submitted the NDA in December, and it expects to begin a Phase 2 clinical study in the first quarter of this year. AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a 6-month sustained period, according to the press release.

ProQR, FDA reach agreement on Phase 2/3 pivotal trial for Leber's congenital amaurosis 10 treatment

ProQR (Leiden, Netherlands) and the FDA reached an agreement earlier this month on the design of ILLUMINATE, a Phase 2/3 pivotal trial for QR-110 (now named sepofarsen) in patients with Leber's congenital amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene. Leber's congenital amaurosis is the leading genetic cause of childhood blindness. The Phase 2/3 trial will be a randomized, double-masked, sham-controlled trial that will initially enroll 30 adults and children assigned to one of three arms, two active dose levels and a sham control arm, with 10 patients in each arm. The trial's primary efficacy endpoint will be a change in visual acuity from baseline in the treated arm compared with the sham-treated control arm at 12 months. The trial is slated to begin the first half of this year, with top-line results ready near the end of 2020.

Price of generic and older drugs increase along with branded drugs

A rise in the cost of generic and specialty drugs throughout medicine were driven primarily by new product entry, according to Inmaculada Hernandez and coresearchers, who used First Databank and pharmacy claims from the University of Pittsburgh Medical Center Health Plan to measure the contribution of new versus existing drugs to the changes in costs of oral and injectable drugs in the outpatient setting between 2008 and 2016. Oral and injectable brand-name drugs rose annually by 9.2% and 15.1%, respectively, and this was largely driven by existing drugs, according to the authors. Costs increased 20.6% and 12.5%, respectively, for oral and injectable specialty drugs, with 71.1% and 52.4% of the price rises attributable to new drugs. Oral and injectable generics had a price increase of 4.4% and 7.3%, respectively, also driven by new drug entry. The study is published in Health Affairs.

Branded nepafenac has better results post-cataract surgery

Better objective and subjective outcomes after cataract surgery occurred with branded nepafenac 0.3% compared with generic ketorolac 0.5%, reported John Hovanesian, MD, and coresearchers. Their prospective case series randomized one eye of each patient to receive ketorolac 0.5% (n=90) or nepafenac 0.3% (n=91) topical drops for 3 days before surgery and 28 days postop. Patients also used moxifloxacin 0.5% four times daily and difluprednate. Baseline characteristics were similar in both patient groups. There was more burning and stinging in the ketorolac group but more blurry or hazy vision and a film or coating on the eye in the nepafenac group ( P<.0001). Statistically significant objective measures for ketorolac versus nepafenac were as follows: corneal staining (64% versus 28%), Oxford grade 2 or greater staining (28% versus 4%), Schulze grade 30 or greater conjunctival erythema (65% versus 36%), and abnormal tear breakup time of more than 10 seconds (77% versus 51%). The study appears in the Journal of Cataract & Refractive Surgery.

Be a part of the new Winning Pitch Challenge Symposium at the 2019 ASCRS/ASOA Annual Meeting

Get ready to enter the "Shark Tank"* with the all new Winning Pitch Challenge Symposium at the 2019 ASCRS/ASOA Annual Meeting. The Round 1 submission deadline is Monday, February 11, 2019. Being held Sunday, May 5, this unique session gives you the opportunity to bring innovation to the field of ophthalmology. During the symposium, selected finalists will present their pitch live to the judges.
The Winning Pitch Challenge is currently accepting Round 1 submissions. Selected submissions are advanced to Round 2 and paired with a mentor on a rolling basis.

*Shark Tank is a registered trademark of Sony Pictures Television and is not affiliated with these services.

Research briefs

  • Descemet membrane endothelial keratoplasty (DMEK) had good postop final visual acuity results in eyes with poor preop vision caused by corneal pathology, reported Silvia Schrittenlocher and coresearchers. Their analysis of 1,162 consecutive eyes of 1,184 patients focused on eyes with DMEK alone or combined with cataract surgery (triple-DMEK). They also analyzed pre- and postop visual acuity values at 1, 3, 6, and 12 months after transplantation. A significant correlation was found between pre- and postop visual acuity after triple-DMEK after 6 and 12 months. A preop visual acuity of below 20/100 led to more delayed and reduced final visual acuity results after 12 months. However, when defining an increase in visual acuity as greater than 0.1 logMAR as clinically relevant, researchers could not show any clinically relevant significant difference in the time needed to recover final visual acuity and in final visual acuity. No significant difference for preop visual acuity values above 20/40 occurred. "The chance to reach postoperative visual acuity above 20/25 is 40% for preoperative visual acuity of 20/200, 50% for preoperative visual acuity of 20/60, and greater than 60% for preoperative visual acuity of 20/40," the researchers wrote. There appears to be a benefit in performing DMEK early, before visual acuity is below 20/100, the authors concluded. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • Meibography results appear to be a sensitive early indicator for meibomian gland disease (MGD), reported Muhammed Yasin Adil and coresearchers. Their cross-sectional study included 538 patients with MGD and 21 healthy controls. Meibomian gland loss was tracked using meibography images of upper and lower lids that were graded on a scale of 0 (lowest degree of loss) to 3. The mean upper and lower lid meibogrades were significantly higher in patients with MGD compared with controls. Sensitivity and specificity of the meibograde as a diagnostic parameter for MGD were 96.7% and 85%, respectively. Meibomian gland morphology correlated significantly but weakly with several clinical parameters. Morphologic analysis of meibomian glands can show an early stage of MGD and is a complementary clinical parameter with diagnostic potential, the researchers concluded. The study is published in the American 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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