EW Weekly, March 22, 2019
- COMPARE glaucoma devices study reports 24-month results
- Long-term IOP reduction seen with OMNI Surgical System Predicate Device
- Phase 2 trial starts for AR-1105 for macular edema with retinal vein occlusion
- Phase 2 study for diabetic retinopathy therapy fails to meet endpoints
- Therapy for AMD is focus of collaboration between two companies
- Alcon acquires PowerVision
- Acucela to develop compact OCT for NASA missions
- Register now: FDA and ophthalmic community workshop on laser-based imaging
COMPARE glaucoma devices study reports 24-month results
Twenty four-month results from the COMPARE study showed that two times the number of patients in the Hydrus Microstent (Ivantis) group (38%) were medication-free compared with patients receiving two iStents (18.7%; Glaukos). COMPARE, a prospective, randomized, comparative microinvasive glaucoma surgery trial, focused on 152 patients with mild to late-moderate stage disease who were seen at 12 centers in nine countries outside of the U.S. None of the eyes with the Hydrus required a reoperation to control glaucoma, compared with 9% in the two-iStent group, according to a press release from Hydrus.
Long-term IOP reduction seen with OMNI Surgical System Predicate Device
A single-center, retrospective study of glaucoma patients showed that ab interno trabeculotomy with the OMNI Surgical System Predicate Device (TRAB360, Sight Sciences) has a good safety profile and long-term IOP reductions as well as a reduction in the use of IOP-lowering medications. The study, led by Steven Sarkisian, MD, included 81 eyes from 69 glaucoma patients having standalone microinvasive trabeculotomy. Almost two-thirds of the eyes had previous glaucoma surgery. At 12 months, there was a 7.3 mm Hg reduction in IOP, from a mean medicated baseline IOP of 23.7 mm Hg to a mean postoperative 12-month IOP of 15.7 mm Hg. Study results are published in Clinical Ophthalmology.
Phase 2 trial starts for AR-1105 for macular edema with retinal vein occlusion
A Phase 2 trial is underway for the dexamethasone intravitreal implant AR-1105 (Aerie Pharmaceuticals) for patients with macular edema due to retinal vein occlusion, according to an Aerie press release. The study will take place at about 20 centers across the U.S. and include up to 45 patients. Safety, tolerability, and efficacy of the implant are the primary objectives. AR-1105 is a bioerodible implant designed to release dexamethasone over 6 months.
Phase 2 study for diabetic retinopathy therapy fails to meet endpoints
A Phase 2b study for AKB-9778 (Aerpio Pharmaceuticals) for moderate to severe nonproliferative diabetic retinopathy did not meet the study's primary endpoint of the percentage of patients with an improvement of two or more steps in the study eye diabetic retinopathy severity score compared to placebo, according to an Aerpio press release. However, the agent showed encouraging data for some key secondary endpoints. The company plans to advance a topical drop formulation of AKB-9778 into clinical development and will initiate a Phase 1b study for the topical drop in the second quarter, with results expected by the end of this year.
Therapy for AMD is focus of collaboration between two companies
OliX and Théa have signed a license and collaboration agreement to develop and commercialize OLX301A, a treatment for dry and wet age-related macular degeneration, according to a press release. The agreement is specific to Europe, the Middle East, and Africa. OliX continues to hold the rights of OLX301A in the U.S. and Asia.
Acucela to develop compact OCT for NASA missions
Acucela Inc. and Kubota Pharmaceutical Holding will develop a compact OCT device for NASA's Deep Space missions, according to an Acucela press release. Because 63% of long-duration spaceflight crew members present with one or more signs of spaceflight associated neuro-ocular syndrome, OCT has become a mainstay of crew testing. Currently available OCT devices are not suitable for expeditionary space travel.
Register now: FDA and ophthalmic community workshop on laser-based imaging
On April 8 from 8:00 a.m. to 4:30 p.m. ET, join ASCRS, the FDA, and ophthalmic community at the Tommy Douglas Conference Center in Silver Spring, Maryland, for a 1-day workshop that will focus on the latest trends and enhancements in ophthalmic laser-based imaging modalities, including: optical coherence tomography and adaptive optics, regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tools program and the emerging role of artificial intelligence. Registration is required to attend. ASCRS members will receive a discounted rate of $295 (in-person) and $275 (webcast). To register for the public workshop, visit Forum on Laser-Based Imaging. If you have any questions or need help registering, contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org.
Research briefs
- Significantly lower vitreous humor levels of Alzheimer's disease-related biomarkers were seen in patients with poor cognitive function, reported Lauren Wright and coresearchers in their prospective, single-center, multi-surgeon cohort study. Researchers focused on levels of biomarkers amyloid beta and tau protein content in human vitreous and its correlation to neurocognition in 80 eyes. Linear regression was used to examine the association between Alzheimer's biomarker levels, the Mini-Mental State Exam (MMSE), and serum apolipoprotein E allele status, with adjustments for age, sex, and education level. Lower MMSE scores had a significant association with lower levels of vitreous amyloid beta40, amyloid beta42, and tTau protein. The biomarkers were not associated with any preexisting eye conditions. To the researchers' knowledge, their work is the first to correlate cognition with Alzheimer's disease-related proteins in the vitreous humor and suggests that ocular proteins may have a role for early dementia detection in individuals at risk for Alzheimer's. The study appears in the Journal of Alzheimer's Disease.
- When comparing three LASIK femtosecond laser platforms in an ex vivo experimental animal study, Gema Bolivar, MD, and coresearchers found that the iFS (Johnson & Johnson Vision) and Victus (Bausch + Lomb) femtosecond systems induced higher IOP increases and required longer surgical times to cut a LASIK flap than the LenSx (Alcon). The IOPs of the 21 porcine eyes in the study were recorded during placement of the suction ring on the eye and during the intrastromal laser application for flap creation. During suctioning, the mean IOP increase was significantly higher (P=0.0001) with the iFS (78.14 mm Hg) than the Victus (20.28 mm Hg). Because the LenSx performs suctioning and applanation phases at the same time, it was not possible to get results from the suctioning phase alone. During the cutting phase, IOP elevation was significantly lower (P=0.0001) with the LenSx (20 mm Hg) compared with the iFS (108.1 mm Hg) and Victus (96.4 mm Hg). The surgical time was significantly lower with the LenSx (17.21 seconds) compared with iFS (25.10 seconds) and Victus (33.40 seconds). The research is published in the Journal of Cataract & Refractive Surgery.
- A study led by Mingguang He, PhD, focused on the efficacy and safety of laser peripheral iridotomy prophylaxis against primary angle closure in Chinese patients classified as primary angle closure suspects. The randomized controlled trial included 889 individuals (889 treated and 889 untreated eyes) that received laser peripheral iridotomy in the treated eye. The primary outcome was incident primary angle closure disease. Incidence of primary angle closure disease was 4.19 per 1,000 eye-years in treated eyes compared with 7.97 per 1,000 eye-years in untreated eyes. In 19 treated eyes and 36 untreated eyes, a primary outcome event occurred. Laser peripheral iridotomy made a modest but significant prophylactic effect, the researchers concluded. However, the benefit of prophylactic laser peripheral iridotomy is limited, so prophylactic use is not recommended. The study appears in The Lancet.
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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