EyeWorld Weekly Update, July 27, 2018

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July 27, 2018
Volume 24 , Number 27

FDA approves two Investigational Device Exemptions for Ocular Bandage Gel

The U.S. Food and Drug Administration (FDA) has approved two of the Investigational Device Exemptions submitted by EyeGate Pharmaceuticals (Waltham, Massachusetts) for pilot studies associated with its Ocular Bandage Gel, created to accelerate the re-epithelialization of large corneal epithelial defects in patients who have had PRK, according to a company press release. The Ocular Bandage Gel is also designed to reduce corneal staining in patients with punctate epitheliopathies. The PRK pilot study will include up to 45 subjects who will have a bilateral procedure; the trial will compare the EyeGate product to a bandage contact lens plus artificial tears. The primary endpoint will be the percentage of subjects achieving complete wound healing on day 3. The punctate epitheliopathies study will include 30 patients in a two-arm, 6-week trial with 15 patients in each arm. The primary performance outcome will be the change in National Eye Institute corneal staining score from day 0 to day 28 between the Ocular Bandage Gel arm and the comparator arm. The trials are expected to begin in this year's third quarter, the company reported.

FDA accepts NDA submission for netarsudil/latanoprost 0.02%/0.005%

The FDA has accepted the New Drug Application for Roclatan (netarsudil/latanoprost 0.02%/0.005%, Aerie Pharmaceuticals, Durham, North Carolina), according to a company press release. The FDA's acceptance indicates that the application is sufficiently complete to permit a substantive review, and the Prescription Drug User Fee Act goal date for completion of the review is March 14, 2019. Roclatan is designed as a once-a-day eye drop to lower IOP in patients with glaucoma or ocular hypertension.

Phase 2 results reported for eye implant offering sustained delivery of biologic for AMD

Positive top-line results have been announced from the Phase 2 LADDER study, which evaluates the efficacy and safety of a Port Delivery System with ranibizumab (Genentech, South San Francisco) in people with AMD. The majority of the patients in the trial lasted 6 months or longer between implantation of the device and the first refill, the company reported in a press release. Visual outcomes in the high-dose Port Delivery System group were similar to monthly ranibizumab eye injections. The outcomes were maintained throughout the study period, according to Genentech. In the LADDER study, patients implanted with the delivery system received a 10 mg/mL, 40 mg/mL, or 100 mg/mL concentration of ranibizumab. Among the 59 patients receiving the 100 mg/mL dosage, about 80% were able to go 6 months or longer until a refill was necessary. In the 40 mg/mL and the 10 mg/mL groups, 71.3% and 63.5%, respectively, lasted 6 months or longer until the first refill. The Phase 3 program is expected to begin later this year.

Top-line Phase 3 results presented for EM-100 ophthalmic solution

Top-line results were announced this week for EM-100 ophthalmic solution (Eton Pharmaceuticals, Deer Park, Illinois), designed as a topical, preservative-free formulate to treat ocular itching associated with allergic conjunctivitis. "Results from the trial demonstrated non-inferiority of EM-100 topical ophthalmic solution to the compactor product in the treatment of ocular itching," a company press release stated. The product also had statistically significant superiority to placebo at all time points, with no adverse events.

Register for the ASCRS and YES Know Your Tools/Toy Box: IOLs webinar

Registration is now open for the upcoming ASCRS and YES webinar Know Your Tools/Toy Box: IOLs," which will take place on August 1 at 9:00 p.m. EDT. This session is sponsored by the ASCRS Young Eye Surgeons (YES) Clinical Committee. Attendees will have the opportunity to explore various IOL platforms and selection using thought-provoking case presentations from some of the top experts in the field. Join moderators Claudia Perez-Straziota, MD, and Naveen Rao, MD, and panelists Nicole Fram, MD, and Sonia Yoo, MD, for an interactive discussion. The webinar is free to ASCRS members and $75 for non-members. Join today.

RESEARCH BRIEFS

  • A significant elevation in matrix metalloproteinases (MMP)-9 was found in patients with lax eyelid syndrome compared with controls, according to Mackenzie Sward and coresearchers. The study, which focused on the connection between lax eyelid syndrome, obstructive sleep apnea (OSA), and ocular surface inflammation, found that among 35 patients with sleep study results, 32 had OSA. However, there was no meaningful association between OSA and MMP-9 (P=.12), according to researchers. "Although there is some evidence to support the association of eyelid laxity and OSA, the most accurate and reliable method for grading eyelid laxity remains unclear," the researchers concluded. The research is published in The Ocular Surface Journal.
  • Polymorphonuclear neutrophils (PMN) promoted meibomian gland obstruction in a chronic inflammatory model of allergic eye disease in mice, reported Nancy Reyes and coresearchers. Their analysis of leukocytes in tears of patients with meibomian gland dysfunction demonstrated an increase in PMN numbers compared with healthy subjects. The PMN numbers correlated with the clinical severity of meibomian gland dysfunction. The results point to a role for PMNs in the pathogenesis and progression of meibomian gland dysfunction, the authors concluded. The research appears in Science Translational Medicine.
  • Biometric measurements completed with the use of the Scheimpflug-Placido optical biometer can be used to calculate IOL power accurately, according to Giacomo Savini, MD, and coauthors. Their evaluation focused on the results of IOL power calculation using different corneal power measurements provided by an optical biometer combined with a dual Scheimpflug analyzer and a Placido disc topographer. The IOL power in the evaluation was calculated with the
  • Barrett Universal II, Haigis, Hoffer Q, Holladay 1, and the SRK/T formulas. A number of options were used to calculate the corneal power, including simulated keratometry based on anterior corneal surface measurements only and total corneal power (TCP) based on ray tracing through both corneal surfaces. Three TCP measurements were analyzed for the 118 study eyes. The mean values of simulated K, TCP1, TCP2, and TCP-IOL were significantly different (P<.0001), according to researchers. The best results were found with simulated K; the median absolute error ranged between 0.22 D and 0.29 D and the percent of eyes with a prediction error of ±0.50 D or less between 76.2% and 84.7%, depending on the formula. The results are published in the Journal of Cataract & Refractive Surgery.

Product News
  • Alcon (Fort Worth, Texas) introduced its Ngenuity 3D Visualization System with Datafusion. With the addition of Datafusion software, Ngenuity also offers integration with the Constellation Vision System, according to the company.

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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