• Johnson & Johnson Vision announced the availability of its presbyopia-correcting IOL (PC-IOL) powered by InteliLight technology, TECNIS Symfony OptiBlue IOL. This extended depth-of-focus lens joins TECNIS Synergy IOL 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 powered by InteliLight is now available for ophthalmologists to use in the United States. These lenses are also available in Toric II for patients with astigmatism.

• Alcon introduced the Clareon Toric IOL with STABLEFORCE Haptics technology, 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. In addition, Alcon expanded its Fidelis Virtual Reality Ophthalmic Surgical Simulator, which was introduced in select markets in May, and 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.

• 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. 

• Harrow and Sintetica, S.A. jointly 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. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

• Santen Inc. and UBE Corp. 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. Omidenepag isopropyl, the active pharmaceutical ingredient in OMLONTI developed by UBE, is a relatively selective prostaglandin EP2 receptor agonist, which increases aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways.

• Ziemer USA introduced of 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.

• 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. Some of the features of the ECHO include a small physical footprint, a full pattern palette that includes grids, circle, and triple arc, a μSec Mode for tissue sparing treatment, a Fiberless design to minimize service repairs and disruption, voice control of patterns and parameters and easy installment on any compatible slit lamp. The ECHO is pending FDA clearance.

• 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 ImprimisRx 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. In addition, ImprimisRx will provide a robust Patient Access Program and a 100% replacement guarantee for any expired 503B Fortisite product.

• CoFi Inc. announced the launch and nationwide availability of a multi-party financing solution, in partnership with Alphaeon Credit, for ophthalmology practices and their surgical partners. Practices now can offer their patients the ability to finance the fees of every party involved in a premium procedure — such as LASIK, SMILE, premium IOL cataract surgery — with funds distributed compliantly and directly to each party.

• 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 allows 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.

• Visus Therapeutics has expanded its ophthalmic drug development portfolio with the acquisition of all patents and other assets of ViewPoint Therapeutics. The library of ViewPoint drug candidates will accelerate development of novel alpha-crystallin chaperone compounds as a non-surgical treatment for age-related cataracts. Lead candidate selection is anticipated in Q1 2023.

• Ammad Khan, IrisVision co-founder and CEO, introduced a new company, 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 single 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. In addition, the Radius XR platform features an immersive educational media library that can be tailored to each patient.

• EyeCare Partners (ECP) announced the launch of the EyeCare Partners Innovation Center with a mandate to improve the delivery and quality of eye care and advance clinical eye health education. The three pillars of the Innovation Center — quality, research and education — will be fueled by ECP’s clinical data warehouse providing insights regarding treatments and outcomes across the eye-care continuum, all gathered from E360+, ECP’s proprietary electronic medical record platform. In addition, the Innovation Center will also open the door to collaboration with private practices, academic institutions and leading industry partners.

• Outlook Therapeutics and AmerisourceBergen have entered into a strategic relationship in preparation for the anticipated commercial launch of ONS-5010/LYTENAVA (bevacizumab-vikg), if approved by the FDA. AmerisourceBergen will provide third-party logistics services and distribution as well as medical information and pharmacovigilance services in the United States. As Outlook Therapeutics moves toward a potential launch, and if ONS-5010 is approved by FDA, AmerisourceBergen’s commercialization support will expand to include additional services, such as patient services and field solutions.

• At AAO 2022, Iridex Corp. is showcasing non-incisional glaucoma treatments, introduce its Sweep Management Software and host 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.

• Tarsus Pharmaceuticals launched the “Look at the Lids” disease education campaign for Demodex blepharitis. The novel campaign is designed to encourage eye-care professionals to screen for Demodex blepharitis in all eye-care patients to identify and diagnose the disease sooner. The campaign features real Demodex blepharitis patients and will include educational tools and resources for eye-care professionals, including an informative website (www.LookattheLids.com), social media channels, webinars, launch events and interactive activities at AAO 2022 and AAOpt in San Diego.

• Trefoil Therapeutics announced positive results from its Phase 2 STORM trial showing multiple positive efficacy outcomes for TTHX1114 as an adjunct to Descemet stripping only (DSO) and a favorable safety profile in patients with Fuchs’ endothelial corneal dystrophy. Data from the Phase 2 STORM trial examined if treatment with the investigational agent, TTHX1114, led to faster vision recovery in patients undergoing a DSO procedure. The trial results revealed recovery of vision to 20/40 in a mean time of 4.2 weeks following DSO and a single intracameral injection of TTHX1114, and a significant dose-dependent effect of TTHX1114 on the recovery of central corneal thickness (CCT), with median CCT recovered to better than baseline by day 84.

• EyePoint Pharmaceuticals announced the first patient has been dosed in the Phase 2 PAVIA clinical trial of EYP-1901, a potential sustained delivery intravitreal anti-VEGF treatment targeting non-proliferative diabetic retinopathy (DR). The primary efficacy endpoint of the trial is improvement of at least two DR severity scale severity levels as of week 36 after the EYP-1901 injection. Secondary endpoints include vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.