- Enrollment begins in Phase 3 pilocarpine study for presbyopia
- New digital platform enhances connectivity among clinic-to-OR technologies
- Positive results from Phase 1 safety study of investigational compound for AMD, DME
- Alcon to acquire Ivantis
- ASCRS news and event
November 12, 2021 • Volume 27, Number 45
Enrollment begins in Phase 3 pilocarpine study for presbyopia
Eyenovia enrolled the first patient this week for its Phase 3 clinical trial of MicroLine, a proprietary pilocarpine formulation intended for short-term presbyopia correction. About 140 subjects with presbyopia will be enrolled in the double-masked, placebo-controlled study. The investigational MicroLine drug and the placebo will be delivered to patients’ eyes via the company’s Optejet dispenser. According to Eyenovia’s press release, the primary endpoint for the study is improvement in high-contrast, binocular distance-corrected near visual acuity measured in a low light condition 2 hours after treatment administration. Topline data is expected mid-2022.
New digital platform enhances connectivity among clinic-to-OR technologies
Alcon announced its new SMART Solutions digital platform, designed to enhance integration and connectivity among systems used in the clinic and OR. According to the company’s press release, within this system is SMARTCataract, which includes planning, connectivity, analysis, and optimization capabilities. The system, according to Alcon, brings together data systems and diagnostic devices like the company’s ARGOS Biometer with Image Guidance, Alcon cataract surgery equipment, such as the LenSx Femtosecond Laser and LuxOR Revalia Ophthalmic Microscope, as well as some of the most commonly used microscopes made by other companies. Alcon plans to add connectivity with its ORA System and its NGENUITY 3D Visualization System soon.
Positive results from Phase 1 safety study of investigational compound for AMD, DME
United Biotechnology announced that the majority of patients with DME or AMD in its Phase 1, single ascending, dose safety study of UBX1325 had rapid improvements in vision; those in higher dose cohorts showed a mean gain of 9.5 ETDRS letters in BCVA at 24 weeks. According to the company’s press release, UBX1325, a small molecule inhibitor of Bcl-xL (a member of a family of apoptosis-regulating proteins), was administered as a single injection to eight advanced DME patients and 11 patients with wet AMD who no longer received anti-VEGF therapy due to a lack of benefit. The investigational compound was well tolerated at all doses. According to the company, a Phase 2 study for DME is underway, and a Phase 2 study for AMD is planned for the second half of 2022.
Alcon to acquire Ivantis
Alcon plans to acquire Ivantis, which makes the Hydrus Microstent, a MIGS device designed to lower IOP in open angle glaucoma patients having cataract surgery within the U.S. (it’s approved in some other countries as a standalone procedure). This acquisition, according to Alcon’s press release, affirms the company’s commitment to the surgical glaucoma space. According to the announcement, Alcon will pay $475 million upfront for the acquisition, but additional contingent payments may be required for certain regulatory and commercial milestones. The acquisition is expected to be complete within the first quarter of 2022.
ASCRS news and events
- Workplace diversity survey: ASCRS, along with other ophthalmic societies, has been asked to participate in a University of Miami Institutional Review Board-approved study exploring workplace diversity and its role in workplace-related stress. Members are requested to complete a short, 4-minute survey to assist with the study. Results are anonymous.
- 20/Happy in 2021: The popular ASCRS Master Class in Refractive Cataract Surgery is back with a new CME module—20/Happy in 2021—to be hosted in person during the AAO Annual Meeting in New Orleans, Louisiana. If you’re attending the AAO Annual Meeting, join the complimentary program Saturday, November 13, 5:00–9:00 p.m. CT at Hilton Riverside, St. Charles Ballroom. Learn more.
- 2022 ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, opens on Monday, November 15.
- ASCRS Winter Symposium: Registration is open for the February 10–12, 2022, Winter Symposium in Park City, Utah. This meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology and will honor Alan Crandall, MD (1947–2020), former co-chair of this meeting, former ASCRS president, and a tireless teacher and humanitarian.
Research highlights
- A randomized, multicenter, double-masked, vehicle-controlled Phase 3 study was conducted to determine the efficacy and safety of OC-01 (varenicline) nasal spray for dry eye disease. Seven hundred and fifty-eight patients with dry eye, artificial tear use, an OSDI score of 23 or more, and a Schirmer’s test score of 10 mm or less were enrolled in the study, which is published in the journal Ophthalmology. Patients were randomized to use a twice-daily treatment of OC-01 0.6 mg/ml, OC-01 1.2 mg/ml, or vehicle into each nostril. Overall, a greater percentage of patients achieved the primary endpoint in both treatment groups compared to control, and change in baseline Schirmer’s score was significantly greater in the test group. There was not a significant difference in eye dryness scores, though they did improve more with the treatment compared to vehicle. At least one treatment-emergent adverse event was experienced by 86.5% of patients, but the researchers noted that most were mild and not ocular (sneezing, coughing, throat irritation, and instillation site irritation).
- Research published in JAMA Ophthalmology provided genetic evidence that increased alcohol intake may be a risk factor for geographic atrophy. Study authors sought to evaluate whether smoking, alcohol intake, blood pressure, BMI, and glycemic traits were associated with AMD. In addition to the findings related to alcohol intake, smoking initiation and a lifetime of smoking were associated with a higher risk of developing advanced AMD. Stopping smoking was associated with a decreased risk of developing advanced AMD. The authors reported that there was not evidence to suggest that genetically predicted blood pressure, BMI, and glycemic traits were associated with advanced AMD.
Product news
- Oyster Point announced that it established a patient affordability and access program that allows some patients with commercial insurance to pay as little as $0 for the company’s recently FDA-approved TYRVAYA Nasal Spray (varenicline solution, 0.03 mg) for signs and symptoms of dry eye disease.
- I-MED Pharma is bringing its dry eye product portfolio to the U.S., selling directly to eyecare professionals.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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