OM’S 40 UNDER 40 HONORED IN CHICAGO
On Friday, Sept. 30, members of the inaugural Ophthalmology Management 40 Under 40 list were honored at a reception held during the 2022 AAO meeting at the Hyatt Regency McCormick Place in Chicago. During the event, OM editorial board member and 40 Under 40 selection committee member Lisa M. Nijm, MD, JD, presented plaques to the 40 Under 40 members in attendance.
Ophthalmology Management announced the 40 Under 40 list in the October 2022 issue. The list was based on nominations received earlier this year and was ultimately determined by a 14-person selection committee. These 40 young ophthalmologists were voted to the list based on their efforts in research, innovation, leadership, teaching, entrepreneurship, academics, global health and more. For the full list, visit bit.ly/3UZaO2c .
NEWS FROM AAO 2022
Updates on new technology announced during the 2022 AAO meeting in Chicago
BVI announced the launch of CryoTreq to the US market. CryoTreq is the first handheld, all-in-one, single-use device for cryosurgery. The device provides ophthalmologists with an effective tool to treat certain potentially sight-threatening retinal tears and detachments. CryoTreq adds to BVI’s rapidly expanding vitreoretinal portfolio, including Vitreq single-use instruments. CryoTreq is available for demonstration during AAO.
CoFi Inc. announced the nationwide availability of a multi-party financing solution, in partnership with Alphaeon Credit, for ophthalmology practices and their surgical partners. Practices can offer their patients the ability to finance the fees of every party involved in a premium procedure — such as LASIK, SMILE and premium IOL cataract surgery — with funds distributed compliantly and directly to each party.
Genentech presented data on Vabysmo. Presentations covered two-year data from the TENAYA and LUCERNE Phase 3 trials in wet AMD and YOSEMITE and RHINE Phase 3 trials in DME supporting its long-term efficacy, durability and safety while also demonstrating Vabysmo’s rapid and sustained effect on anatomical outcomes.
Harrow and Sintetica, S.A. announced the FDA approval of IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. IHEEZO is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation containing no preservatives that is safe and effective for ocular surface anesthesia. IHEEZO represents the first approved use in the US ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the US ophthalmic market in nearly 14 years.
Horizon Therapeutics presented data defining molecular patterns in thyroid eye disease (TED) and further implicating the role of insulin-like growth factor-1 (IGF-1) in patients with low Clinical Activity Score (CAS). TED has been historically characterized as biphasic: acute, which is traditionally believed to be patients with high CAS and earlier in their TED journey; and chronic, traditionally believed to be patients with low CAS and later in the course of their disease. This analysis revealed that in patients with both high and low CAS, there is clear activation of IGF-1 and related pathways, as well as the extracellular matrix organization, a structural network that supports cellular processes.
ImprimisRx announced the availability of Fortisite, which includes a patent-pending compounded combination of tobramycin 1.5% and vancomycin 5%. Fortisite is tested for both potency and sterility before it is dispensed and is stable at refrigerated temperatures (5°C) for up to 180 days. Fortisite formulations are currently available for individual patients through the ImprimisRx 503A national mail order pharmacy. Once available through the Imprimis-Rx FDA-registered and FDA-inspected 503B outsourcing facility, which is expected in the first half of 2023, physicians will be able to stock a fortified or high-concentration compounded antibiotic in their offices for the immediate treatment of patients-in-need.
Iridex Corp. showcased non-incisional glaucoma treatments, introduced its Sweep Management Software and hosted eight physician presentations. MicroPulse Transscleral Laser Therapy (TLT) continuous-wave transscleral cyclophotocoagulation and MicroPulse Laser Trabeculoplasty are non-incisional treatments that expand ways to manage, preserve and prolong vision for glaucoma patients. The company’s Sweep Management Software for MicroPulse TLT is now integrated into the Cyclo G6 Glaucoma Laser System and supports the sweep duration methodology shared by the International MicroPulse TLT Delphi Panel.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the primary results from the Phase 1/2 study evaluating the investigational gene therapy botaretigene sparoparvovec (formerly AAV-RPGR) in patients with the inherited retinal disease X-linked retinitis pigmentosa associated with the retinitis pigmentosa GTPase regulator gene, or RPGR. Treatment with botaretigene sparoparvovec was found to have an acceptable safety profile, and efficacy assessments in this proof-of-concept study demonstrated encouraging improvements in retinal sensitivity, visual function and functional vision.
With Norlase’s newest laser, ECHO, the laser and scanning technology are integrated into a small, portable device that can be adapted to a slit lamp. Features include a small physical footprint and a μSec Mode for tissue sparing treatment. ECHO is pending FDA clearance.
Ora Inc. launched the Ora EyeCup mobile research platform. The Ora EyeCup transforms patient data capture through high-resolution imaging, artificial intelligence (AI) analysis and real-time patient feedback. A smartphone attachment and software application allow patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability and corneal health.
Santen announced the FDA-approved OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002% eyedrops for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. OMLONTI is developed jointly by Santen and UBE.
Tarsus Pharmaceuticals launched the “Look at the Lids” education campaign for Demodex blepharitis. The novel campaign, which features real Demodex blepharitis patients, is designed to encourage eye-care professionals to screen for Demodex blepharitis in all patients to identify and diagnose the disease sooner. Educational tools and resources include an informative website (www.LookattheLids.com ), social media channels and webinars.
Ziemer USA introduced GALILEI ColorZ with ZEISS VERACITY Surgical compatibility. The GALILEI ColorZ G4 and G6 represent the new generation of the diagnostic platform, offering multilayer TopView images in vibrant colors and high contrast to provide enhanced visualization of numerous details, including blood vessels, iris patterns and the pupil. OM
WHAT’S NEW IN INTRAOCULAR LENSES
Alcon introduced the Clareon Toric IOL with STABLEFORCE Haptics technology with demonstrated rotational and axial stability, completing the Clareon collection for US cataract patients with astigmatism on its latest, glistening-free material. Clareon Toric and Clareon Monofocal consistently deliver a broad refractive landing zone, providing functional intermediate vision while maintaining the expected 20/20 visual acuity at distance. The completed Clareon Collection of IOLs includes Clareon Toric, Clareon Monofocal, Clareon PanOptix, Clareon PanOptix Toric, Clareon Vivity and Clareon Vivity Toric. The Clareon Collection of IOLs are available in UV-absorbing and blue light filtering foldable options in the United States.
Johnson & Johnson Vision announced the availability in the United States of its presbyopia-correcting IOL (PC-IOL) powered by InteliLight technology, TECNIS Symfony OptiBlue IOL. InteliLight is a combination of three Johnson & Johnson Vision proprietary technologies: violet-light filter, echelette design and achromatic technology. The technology was first introduced in the TECNIS Synergy IOL. This extended-depth-of-focus lens joins TECNIS Synergy in the InteliLight portfolio. These two complementary products deliver sharp contrast and low-light performance across the PC-IOL category. The TECNIS PC-IOL portfolio is now available for ophthalmologists to use in the United States. These lenses are also available in Toric II for patients with astigmatism.
The Lenstec SBL-3 IOL (segmented bifocal lens) was recently approved by the FDA. According to the FDA clinical trial, patients achieved 92.5%, 90.9% and 90.2% for binocular uncorrected distance, intermediate and near visual acuity, respectively, at 20/25 or better. Additionally, the mean visual disturbance rate was 2.15 out of 10. The next-generation asymmetric multifocal refractive IOL is used in adult patients who have cataracts, need eye surgery and only have one diopter or less of abnormal curve to the cornea.
The SBL-3 multifocal IOL is designed to provide patients with near, intermediate and distance vision. Its patented design allows for improved contrast sensitivity and minimized halo and glare. The segmented optic design is the first of its kind in the United States. capsule.
IN THE NEWS:
Glaukos Corp. reported positive topline data for both Phase 3 pivotal trials of iDose TR that successfully achieved its pre-specified primary efficacy endpoints through 3 months in both Phase 3 trials, and demonstrated excellent tolerability and a favorable safety profile through 12 months. Glaukos plans to move forward with a new drug application (NDA) submission to the FDA for the slow-release iDose TR model.
The primary endpoints were met in two pivotal trials by Regeneron Pharmaceuticals investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet AMD. The PHOTON trial in DME and the PULSAR trial in wet AMD both revealed that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.
Tarsus Pharmaceuticals submitted an NDA to the FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, a highly prevalent eyelid margin disease that does not have any FDA-approved treatment options.
Bausch + Lomb and Novaliq GmbH announced that the FDA has accepted the NDA filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eyedrop with a novel mechanism of action, NOV03 treats the signs and symptoms of dry eye disease associated with meibomian gland dysfunction.
Ocuphire Pharma announced that the FDA granted a small business waiver of the Prescription Drug User Fee Act fee of $3.1 million for the 505(b)(2) NDA for Nyxol (phentolamine ophthalmic solution), the company’s late-stage product candidate. Ocuphire remains on track to file the NDA for Nyxol in its first indication, reversal of mydriasis, in late 2022.
Coherus BioSciences reported the commercial availability of CIMERLI (ranibizumab-eqrn), the first FDA-approved biosimilar product interchangeable with Lucentis (ranibizumab injection) for all indications.
Outlook Therapeutics re-submitted its biologics license application to the FDA for ONS-5010, an investigational ophthalmic therapy. If approved, it will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD.
Alcon expanded its Fidelis Virtual Reality Ophthalmic Surgical Simulator, which is now available for pre-order for customers in the United States. Fidelis offers a high-fidelity, virtual operating room environment with haptic feedback to simulate the look and feel of cataract surgery, helping new surgeons hone their skills.
Ammad Khan, IrisVision co-founder and CEO, introduced Radius XR, which offers a portable vision diagnostic and patient engagement system that combines medical-grade diagnostics, business management and patient education tools in a wearable AR/VR device. Using the Radius XR headset, patients can self-perform a range of vision tests that are clinically equivalent to gold standard exams that include: visual field, visual acuity, contrast sensitivity, Amsler grid and color scheme.
![]({"src":"/media/bbjbglou/cover_omd_1122.jpg","focalPoint":null,"crops":[{"alias":"thumbnail","width":1110,"height":700,"coordinates":null}]})