EW Weekly, November 2, 2018

November 2, 2018
Volume 24 , Number 40

First noninvasive LVC procedures performed

The first noninvasive laser vision correction procedure, called laser induced refractive index change (LIRIC), has been performed, according to Clerio Vision (Rochester, New York). Five partially sighted subjects have been treated in LIRIC's first-in-human study, the company stated in a press release. The procedure is based on ultrafast laser technology originally developed at the University of Rochester. Femtosecond techniques were modified for noninvasive ophthalmic applications. In preclinical studies with LIRIC, femtosecond lasers were optimized to change the refractive index of cornea tissue. The modifications can be used to correct myopia, hyperopia, astigmatism, and presbyopia. Clerio is also leading clinical trials of new contact lens designs using LIRIC technology and refining the technology for IOL applications.

Clinical program initiated for MK Melt conscious sedation drug

Additional studies will soon begin for MKO Melt (midazolam/ketamine/ondansetron, Melt Pharmaceuticals, a subsidiary of Imprimis Pharmaceuticals, San Diego), a sublingual product that provides conscious sedation. One study will establish the pharmacokinetics and pharmacodynamics of midazolam and ketamine after administration of the patented MK Melt in up to 25 healthy volunteers, according to a company press release. The measurements will identify the time course of effects of MK Melt in relation to the concentrations of its component drugs in the body. That study is expected to be finished in the fourth quarter of this year. A second study with MKO Melt will focus on conscious sedation during dental surgery. The studies, along with a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration (FDA) slated for January, will inform Melt's clinical development programs for 2019, according to the company.

Phase 3 clinical development program announced for omidenepag isopropyl for glaucoma

A Phase 3 development program called SPECTRUM will evaluate the investigational use of omidenepag isopropyl (DE-117, Santen, Emeryville, California) to treat glaucoma or ocular hypertension. The SPECTRUM program will include two pivotal, randomized, double-masked, active-controlled, parallel-group multicenter trials to compare omidenepag isopropyl with timolol maleate 0.5%. Each SPECTRUM trial will enroll about 400 adult patients and up to 30 pediatric patients around the U.S. who are diagnosed with glaucoma or ocular hypertension. Previous trials with the agent found it performed similar to latanoprost in IOP reduction and that it was generally safe and well-tolerated.

Phase 2 trial results reported for agent used to treat severe dry eye patients

A clinical improvement in severe dry eye patients was seen in the Northern Lights Phase 2 trial that focused on the safety and efficacy of MC2-03 (PADciclo, MC2 Therapeutics A/S, Copenhagen, Denmark). The agent is an eye drop with cyclosporine that is formulated using the company's proprietary PAD Technology. The randomized, double-masked, parallel-arm, controlled 6-month trial enrolled 263 adult patients; two active treatment arms were compared to two control arms as an add-on therapy to a standard-of-care lubricant. The active treatment arms showed a similar, consistent trend for a higher proportion of corneal fluorescein staining responders than vehicle. Among 108 patients who were severe, 58 were randomized to the combined MC2-03 active arms. Patients with severe keratitis appeared to benefit more from active treatment as more patients treated with active MC2-03 were corneal fluorescein staining responders when compared with a combined control arm. No serious adverse events occurred; the most common adverse events in the active arm included eye pain and irritation, both of which were not common.

Zeiss acquires ianTECH

Carl Zeiss Meditec (Jena, Germany) has entered an agreement to acquire ianTECH (Reno, Nevada), a privately held company focused on technology solutions for micro-interventional cataract surgery.

Companies sign exclusive AI platform agreement for the U.S. market

IDx (Coralville, Iowa) and Topcon (Oakland, New Jersey) have signed an exclusivity agreement to allow the company to scale delivery of artificial intelligence-based diagnostic solutions in the U.S. market. IDx will be the only autonomous company in the U.S. to sell its products with the Topcon NW400 fundus camera; the NW400 will be the only robotic desktop fundus cameral with a less than 55-degree field of view to be integrated with the IDx-DR, a system recently approved by the FDA to detect diabetic retinopathy in fundus images.

FDA approves new bimatoprost solution

The U.S. FDA has approved Akorn Pharmaceutical's (Lake Forest, Illinois) Abbreviated New Drug Application for bimatoprost ophthalmic solution 0.03%. The solution is indicated to treat hypotrichosis of the eyelashes by increasing their growth, according to a company press release.

ASCRS/ASOA Annual Meeting Early Bird pricing ends next week

Register today for the 2019 ASCRS/ASOA Annual Meeting, May 3-7, and gain access to the best programming available for anterior segment surgeons. This year ASCRS/ASOA is offering Early Bird pricing, which ends on Wednesday, November 7. Make the most of the Annual Meeting by registering for the "ASCRS/ASOA Annual Meeting + ASCRS Subspecialty Day" category, which provides full access to ASCRS Programming such as instructional courses, symposia and Friday's ASCRS Subspecialty Day programming (ASCRS Glaucoma Day, ASCRS Refractive Day and Cornea Day [sponsored in conjunction with the Cornea Society]). You will also be able to register for the popular Skills Transfer Labs.

*Must have current membership to attend the Annual Meeting
**Does not include Skills Transfer Labs

Research Briefs

Research briefs
  • A new protocol for epithelium-on corneal crosslinking (CXL) stopped the progression of keratoconus and ectasia after LASIK, reported R. Doyle Stulting, MD, and coresearchers. Their prospective observational study used a new riboflavin formulation without epithelial removal then exposed patients to ultraviolet light (365 nm) at 4 mW/cm2 with on/off cycling for 30 minutes. At 3, 6, 12, and 24 months, researchers measured the uncorrected (UDVA) and corrected distance visual acuities (CDVA), total higher-order aberrations, and other parameters. A total of 512 eyes of 308 patients with keratoconus or forme fruste keratoconus and 80 eyes of 55 patients with ectasia after LASIK were treated with the new riboflavin formulation without epithelial removal. A total of 229 patients received bilateral treatments, 95 of which were simultaneous. The mean UDVA and CDVA improved by 1 to 1.5 Snellen lines at 1 and 2 years. Total mean higher-order aberrations and coma lowered by 36% and 37%, respectively. There were no vision-threatening events. The protocol led to a more rapid visual recovery compared with epithelial removal during CXL and allowed for bilateral, simultaneous treatment, the researchers concluded. The study appears in the Journal of Cataract & Refractive Surgery.
  • In an elderly, Caucasian population, there was a substantial overdiagnosis of open angle glaucoma (OAG), according to P. Founti and coresearchers. Their cross-sectional, population-based study randomly chose subjects age 60 or older (n=2554) who were part of the Thessaloniki Eye Study in Greece. They defined OAG as the presence of structural and functional damage, irrespective of IOP. An overdiagnosis in non-OAG subjects was defined by a prior glaucoma diagnosis, prior laser for glaucoma, and prior glaucoma surgery. Among the 2.2% subjects with self-reported glaucoma, 60% were overdiagnosed with OAG. Worse visual acuity, a family history of glaucoma, and history of cataract surgery were statistically significantly associated with OAG overdiagnosis. However, age, sex, higher IOP, higher vertical cup-to-disc ratio, and pseudoexfoliation were not significantly associated with overdiagnosis. Glaucoma overdiagnosis has not been previously addressed in population-based studies and needs further examination, the researchers concluded. The study appears in Acta Ophthalmologica.
Product briefs
  • Bausch + Lomb (Bridgewater, New Jersey) released its eyeTelligence applications, which will run on the IBM Cloud to help eye surgeons and surgical facilities work more efficiently using the company's Stellaris Elite system.
  • Quantel Medical (Cournon D'Auvergne, France) launched its Vitra 810 laser and SubCyclo probe.
  • EyeMD EMR Healthcare Systems (Bonita Springs, Florida) debuted its EyeMD EMR 2.0.

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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