At the American Academy of Ophthalmology (AAO) annual meeting this weekend, Alcon, Inc. offered a sneak peek of three new surgical-based products—including a newly rebranded direct selective laser trabeculoplasty [DSLT] device—as well as a preview of clinical findings on its innovations.
Let’s start with this DSLT device.
The background: You may remember Alcon’s purchase earlier this year of the Israeli glaucoma surgery company BELKIN Vision. (And if you don’t, we’ve got you covered).
A major component of that acquisition was BELKIN’s flagship product: The Eagle.
- What it is: A Q-switched, 532 nm-wavelength, frequency-doubled, neodymium-doped yttrium aluminum garnet (Nd:YAG) laser device designed to provide an automated and non-invasive solution for glaucoma surgery.
- And most notably: The device is the first—and currently only—FDA 510(k)-cleared DSLT laser for glaucoma delivering laser energy through a non-contact approach via the cornea.
How does this device stack up against regular SLT?
See previous clinical data supporting its usage versus standard SLT in reducing intraocular pressure (IOP) among patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
The device addresses key challenges associated with traditional SLT procedures, noted Sean Clark, Alcon president and general manager for Global Surgical Franchise.
Chief among these: Patient discomfort and inefficiency for the physician.
Nice! Speaking of Alcon …. the company rebranded it, right?
Indeed they did. Its new name: The Voyager DSLT device.
Alcon’s goal: Integration of the device into its already-established Alcon Vision Suite.
- To note: The device is already commercially available in the European Union (EU) and United Kingdom (UK) markets.
And its US commercial launch plans?
During an AAO media event, the company plans to launch the Voyager in the U.S. by Q1 2025.
The significance: By expanding Alcon’s portfolio into the auto-therapeutic space with this device, the company intends to not only make SLT—or, in this case, DSLT—more accessible but also shift the paradigm towards making it a first-line therapy.
How exciting! Now onto these other products making their debut.
Two gas delivery systems with the indication of treating uncomplicated retinal detachments.
- UNIFEYE Gas Delivery System
- At a glance: This handheld device is intended to provide surgeons with a predictable, precise gas-to-air ratio via integrating all components for gas delivery.
- The intent: Reducing the risk of accidental gas-to-air mixture delivery and a simplified / streamlined setup—with no need for manual attachment of gas cylinders and filters
- At a glance: This handheld device is intended to provide surgeons with a predictable, precise gas-to-air ratio via integrating all components for gas delivery.
- UNIPEXY Gas Delivery System
- At a glance: Also portable, the device is designed for in-clinic use and involves an “integrated single-dose pico-cylinder comprised of perfluoropropane or sulfur hexafluoride.”
- The intent: Enabling a surgeon to perform pneumatic retinopexy via one device
- At a glance: Also portable, the device is designed for in-clinic use and involves an “integrated single-dose pico-cylinder comprised of perfluoropropane or sulfur hexafluoride.”
How are these systems a game-changer for surgeons?
These are designed to “empower efficiency for retina specialists” in delivering the use of expansive gasses in the operating room (OR) as well as ensure they have the right air-to-gas ratio in the OR, according to Sergio Duplan, senior vice president (SVP), president, Americas at Alcon.
And are they commercially available yet?
Not at the moment … similar to the Voyager, Alcon anticipates a 2025 commercial launch date.
Until then, AAO attendees can get an exclusive preview and demo the products at the Alcon booth (#4008).
Topic switch: What new clinical data was presented?
We’ll give you all three:
- Title: Comparing the effects of two different intraocular pressure settings during routine phacoemulsification in patients with diabetic retinopathy and glaucoma; a randomized controlled feasibility trial (ENHANSE)
- Presented via electronic poster: David H. Steel, FRCOphth, MBBS
- Title: Evaluation of the ergonomic consequences of using NGENUITY 3D compared to the standard microscope for cataract surgery, focused on eye movements, head positioning, blink rate, and posture.
- Presented via electronic poster: Everardo Hernandez-Quintela, MD, MSC
- Title: Visual Performance of a Trifocal IOL in Patients with Mild Open-Angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery
- Presented via electronic poster: Steven D. Vold, MD
Any others?
Yes! The company also presented pivotal data from its phase 3 COMET-2 (NCT05285644) and COMET-3 (NCT05360966) clinical trials evaluating AR-15512 (acoltremon ophthalmic solution 0.003%) for treating the signs and symptoms of dry eye disease (DED).
About the candidate: AR-15512 is a topical transient receptor potential melastatin 8 agonist (TRPM8; a cold-sensing receptor located in the cornea and eyelid with the potential to relieve symptoms of DED).
- To note: It was originally developed by Aerie Pharmaceuticals before being acquired by Alcon in November 2022.
And these clinical studies: Read the company’s previous update on positive topline data from earlier this year.
And this new data on it?
Those latest findings were presented this weekend by David Wirta, MD, via an electronic poster: AR-15512: A Novel TRPM8 Agonist for the Treatment of the Signs and Symptoms of Dry Eye.
Stay tuned for details on those findings by checking back at Glance!