Reporter’s ASCRS Notebook: Five Things in Dry Eye, MIGS, Imaging, and Mydriatics
SAN DIEGO – The 2019 meeting of the American Society of Cataract and Refractive Surgery is about a month in the rearview mirror, but these five companies shared advances in technology that endure.
Eye Drop Demonstrates Effective API
Eric D. Donnenfeld, MD, presented results of an ex-US proof-of-concept clinical trial of Allegro Ophthalmics’ new investigational topical anti-integrin candidate, ALG-1007, in patients with dry eye disease (DED). The trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient in ALG-1007 is effective in improving the signs and symptoms of DED, with improvement as early as two weeks. At the highest dose concentration, ALG-1007 demonstrated statistically significant efficacy in nearly all assessments and a more rapid onset of action compared with the lowest dose. ALG-1007 was well tolerated with no drug-related adverse events, and there was no reported blurring of vision or ocular irritation.
Nasal Spray Used to Promote Tear Production in Dry Eye
Oyster Point Pharmaceuticals presented data on its product candidates for DED, which are delivered via an ocular surface-sparing nasal spray designed to stimulate the trigeminal parasympathetic pathway to promote natural tear film production. In Phase IIb clinical studies, patients administered either OC-01 or OC-02 experienced rapid and significant improvements in both the signs and symptoms of DED. Both products were well tolerated with no significant ocular adverse events or drug-related serious adverse events. President and CEO Jeffrey Nau, PhD, said, “I’m excited by the great progress Oyster Point has made this past year as we prepare to advance our lead product candidate into Phase III clinical development.”
Trials Show Micro-Dosing Treatment Is Safe and Effective
David Wirta, MD, presented safety and efficacy results from Eyenovia’s two Phase III trials, MIST-1 and MIST-2, for pharmacological mydriasis (pupil dilation). In both trials, the agents were administered via Eyenovia’s Optejet dispenser that allows for dosing of approximately 8 microliters, which is less than 25% of the dose volume typically administered with an eye dropper. In each trial, MicroStat, Eyenovia’s proprietary fixed-combination, micro-dosed ophthalmic solution, was shown to be safe and effective for pharmacological mydriasis, achieving clinically and statistically superior mean pupil dilation. Collective results show approximately 94% of treated eyes achieved pupil dilation of at least 6 mm at 35 minutes post-instillation. Dilation was rapid in most patients, with up to 64% of fixed-combination treated eyes achieving 6 mm or greater dilation as early as 20 minutes post-installation. Adverse events were infrequent, transient, and generally mild in nature.
ZEISS Announces Breakthroughs in Digital Technology and Imaging
Carl Zeiss Meditec featured the ARTEVO 800, the first digital microscope in ophthalmic surgery, and the CLARUS 700, which is the first device that combines ultra-widefield (UWF) imaging, excellent image quality, and a full range of fundus imaging modalities, including fundus angiography. Zeiss also announced the completion of 2 million SMall Incision Lenticule Extraction (SMILE) treatments to date, a minimally invasive corneal refractive procedure performed using the VisuMax femtosecond laser. Jim Mazzo, global president of ophthalmic devices, said, “We’re excited to be here at ASCRS with our customers to share the latest in digitalization, industry-first imaging technology, and industry-first milestones.”
Sight Sciences Showcases Products for Dry Eye and MIGS
Sight Sciences recently announced the commercial launch of the dry eye product TearCare, which was shown in its exhibit booth. The company also introduced an aesthetically and ergonomically enhanced OMNI Surgical System for micro-invasive glaucoma surgery. The TearCare device allows the patient’s eyes to remain open and blinking during the procedure where localized heat application is needed. Soft, flexible thermal devices conform to the eyelids to deliver a therapeutic level of heat for a specific period of time to soften and liquefy meibum. The OMNI Surgical System enables the targeting of all three sources of resistance in the conventional outflow pathway (trabecular meshwork, Schlemm’s canal, and collector channels) with a single device and single surgery. The next-generation OMNI system features improvements in device preparation, handling and ergonomics, and aesthetics.
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