Here’s a review of clinical trial results and new technology rolled out at the latest gathering of the American Academy of Ophthalmology in New Orleans.
MIGS: Hydrus Microstent Trial Meets Endpoints
The pivotal HORIZON trial of the Hydrus Microstent (Ivantis Inc.), a micro-invasive glaucoma surgery (MIGS) device, met both the two-year primary and secondary endpoints, Paul Harasymowycz, MD, reported. He noted that 77.2% of Hydrus Microstent patients achieved a 20% or greater reduction in intraocular pressure at 24 months, compared with 57.8% in the cataract-only group. Ivantis has submitted the final module of its PMA containing the HORIZON trial results to the Food and Drug Administration (FDA) for market approval.
RETINA: Brolucizumab Results
A few noteworthy presentations at the Retina Subspecialty Day session reported first-time results on the efficacy and safety of emerging therapies. Pravin Dugel, MD, presented 48-week results of the Hawk and Harrier trials of Novartis’ brolucizumab, otherwise known as RTH258, that included head-to-head comparison with aflibercept (Eylea, Regeneron). “Brolucizumab demonstrated noninferiority in best-corrected visual acuity versus aflibercept with a majority of patients maintained on a q 12-week interval,” he said. Patients on brolucizumab also demonstrated less disease activity at week 16 and superior central subfield thickness reductions at weeks 16 and 48, with a safety profile comparable to existing anti-VEGF treatments. Novartis expects to file for an indication for neovascular age-related macular degeneration (AMD) by Q4 2018 and expects to start clinical trials in diabetic macular edema (DME) and retinal vein occlusion in 2018.
CLS-TA with and Without Aflibercept
Also at the first-time results session, Charles Wykoff, MD, PhD, reported on results of the Phase I/II HULK study of suprachoroidal triamcinolone acetonide injection (Clearside Biomedical Inc.), known as CLS-TA, both with and without intravitreally injected aflibercept for treatment of DME. In the six-month open-label trial of 20 eyes, all eyes showed improvement in best-corrected visual acuity (BCVA) and central subfield thickness, but more so in treatment-naive patients. Multiple suprachoroidal CLS-TA injections were well tolerated with a low incidence of intraocular pressure elevation, Dr. Wykoff said. Clearside president and CEO Daniel White said at OIS@AAO 2017 that a complete readout of Phase II HULK data is expected in 2019.
Update on Neurotech’s NT-501
On behalf of the MacTel Project Research Group, Emily Chew, MD, reported on the Phase II trial of Neurotech’s NT-501 ciliary neurotrophic factor (CNTF) implant for macular telangiectasia type 2. The study involved 67 patients and 99 eyes. Macular telangiectasia, or MacTel, is a neurodegenerative disease with characteristic alterations of the retinal vasculature and localized retinal degeneration. “CNTF had a beneficial effect and reduced the progressive loss of photoreceptors compared to untreated eyes,” Dr. Chew said. “There was good correlation between structural and functional changes … and a very good safety profile.” Neurotech is preparing for two Phase III trials, she added.
Interim Data of Ocular Melanoma Agent
Aura Biosciences unveiled interim safety data from an open-label Phase Ib/II study of its lead program, light-activated AU-011 for the treatment of primary ocular melanoma. Carol Shields, MD, of Wills Eye Hospital presented during the late-breaking session at Retina Subspecialty Day that the drug was well tolerated in the first six patients at three to six months of treatment. AU-011 consists of viral nanoparticle conjugates that bind selectively to unique receptors on cancer cells in the eye. Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys tumor cell membranes while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. The FDA has granted AU-011 ocular melanoma orphan drug and fast-track designations.
DEVICES: Cataract Platform Integrates Oculus Imaging
TrueVision Systems announced at AAO 2017 a partnership that integrates the Oculus Pentacam AXL anterior eye segment tomography system and TrueVision’s TruePlan and IOLcompass computer guidance software for use in cataract and refractive procedures using Leica Microsystems’ surgical microscopes.
Zeiss Unveils Digital Surgical Platform
Zeiss rolled out three new pieces of diagnostic and surgical technology at the AAO meeting. It introduced the Veracity Surgical digital platform, the first application Zeiss’ medical technology business group has introduced since the company acquired Veracity Innovations LLC earlier this year. Veracity is designed to generate cataract surgical plans by extracting data from the surgeon’s electronic medical records. Zeiss also introduced the Clarus 500 Ultra-widefield fundus imaging system, the first to combine the proprietary True Color technology, which resembles the coloration of the retina down to 7 microns, with ultra-widefield imaging. Additionally, Zeiss unveiled the Humphrey Field Analyzer (HFA3) SITA Faster, a testing strategy that can reduce visual field testing time by 50%, meaning patients can complete testing in about two minutes. Both Clarus 500 and HFA3 connect to the FORUM platform and its respective retina and glaucoma modalities.
LENSAR Feature Gets FDA Clearance
During AAO 2017, LENSAR Inc. announced it had received FDA 510(k) clearance, along with the European Union CE mark, for its IntelliAxis-L as a new feature with the latest LENSAR laser system upgrade, Streamline IV. LENSAR describes IntelliAxis-L as a unique reference mark that locates the steep corneal axis at the capsular plane for intraoperative and postoperative toric intraocular lens (IOL) alignment.