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Quick Notes: April 10, 2024

Positive Phase 3 data for presbyopia treatment; RxSight launches its newest Light Adjustable Lens, the LAL+; and more.

Ophthalmology Management April 10, 2024

  • LENZ Therapeutics announced positive topline results from its Phase 3 CLARITY study of two investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia. In Phase 3 safety and efficacy trials (CLARITY 1 and 2), LNZ100 (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in BCDVA at near, without losing one-line or more in distance visual acuity. In the vehicle-controlled CLARITY 2 trial, the Day 1 results showed (all p<0.0001) 71% achieved three-lines or greater improvement at 30 minutes; 71% achieved three-lines or greater improvement at 3 hours; and 40% achieved three-lines or greater improvement at 10 hours. Near vision improvement was reproducible and consistent across both CLARITY 1 and 2 throughout the 4-week study periods. LNZ101 showed similar results, including achieving primary and secondary endpoints in both CLARITY 1 and 2, but did not show superiority to LNZ100. Based on these results, LENZ selected LNZ100 as its lead product candidate, for which it plans to submit a new drug application (NDA) in mid-2024. For more, see the study results here.

  • RxSight Inc. announced the commercial launch of its newest Light Adjustable Lens, the LAL+. The company now offers two lenses in the Light Adjustable Lens platform: the LAL and the Light Adjustable Lens+ (LAL+). The LAL+ has a modified aspheric anterior surface that creates a small continuous increase in central lens power, which is designed to slightly extend the depth of focus. The RxSight Light Adjustable Lens system, comprised of the LAL/LAL+, RxSight Light Delivery Device and accessories, is the first commercially available IOL technology that can be adjusted after surgery, enabling doctors to customize and deliver high-quality vision to patients after cataract surgery. 

  • Glaukos Corp. announced the U.S. Centers for Medicare and Medicaid Services (CMS) assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of IOP in patients with ocular hypertension or open-angle glaucoma (OAG). The new J-code for iDose TR, J7355, is set to become effective July 1, 2024. It is expected to increase patient access in the United States and has been published on the CMS website here. In addition to the J-code, CMS issued its April 2024 Update of the Hospital Outpatient Prospective Payment System transmittal on the CMS website, in which it assigned the CPT codes that are designed to be used to cover the procedural component of iDose TR, 0660T and 0661T, to ambulatory payment classification 5492 (Level 2 Intraocular Procedures), effective April 1, 2024.

  • Orbis International and FundamentalVR launched a virtual reality (VR) training solution built to support students and residents learning to perform surgery to treat cataracts. The tool integrates VR, haptic feedback, cloud assessment data and off-the-shelf hardware to create a solution for cataract surgical training in resource-limited settings. Immersive VR simulation integrated with haptics provides a realistic experience for physicians who are able to practice each step repeatedly to cement their understanding of both basic and difficult techniques, the companies say. This training tool enables independent learning through automated performance monitoring and feedback, a particular benefit to medical professionals without access to robust ophthalmic training opportunities. 

  • At the ASCRS Annual meeting, Sight Sciences presented data from studies of two of its proprietary glaucoma and dry eye technologies, the OMNI Surgical System and the TearCare System. The data was presented in two oral presentations and two posters. According Arkadiy Yadgarov, MD, of Omni Eye Services of Atlanta, Ga., “The 12-month GEMINI trial demonstrated efficacy of the OMNI procedure combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. This extension of the trial shows that these positive 12-month outcomes were sustained through 36 months.” In addition, the TearCare data demonstrated tear break-up, meibomian gland, and dry eye symptom improvement and “support the conclusion that TearCare should be a preferred treatment for DED associated with meibomian gland dysfunction,” says Brandon Ayres, MD, of Wills Eye Hospital, Philadelphia.

  • After securing all required regulatory approvals, Carl Zeiss Meditec AG completed the acquisition of 100% of D.O.R.C. (Dutch Ophthalmic Research Center) from the investment firm Eurazeo SE, Paris. The acquisition enhances and complements ZEISS Medical Technology’s broad ophthalmic portfolio and range of digitally connected workflow solutions for addressing a wide variety of eye conditions, spanning retina and cornea disorders, cataract, glaucoma, and refractive errors. With D.O.R.C., ZEISS can offer an expanded, digitally-connected Retina Surgery Workflow from ZEISS. 

  • OASIS Medical launched the SOFT PLUG Extended Duration 180-T Tapered Plug. The plug is designed with a .25mm tapered end for ease of insertion into the punctal opening. The plug then gradually widens to a .6mm diameter at the top end to contribute to occlusion of the canaliculus. After insertion through the punctal opening and into the canaliculus, it degrades in approximately 180 days. The plugs are made from degradable polydioxanone monofilament and are intended to temporarily block tear drainage by the occlusion of the canaliculus to temporarily treat dry eye syndrome and the dry eye components of various ocular surface diseases. 

  • Eric Donnenfeld, MD, presented positive results from the Phase 3 OPTIMIZE-1 trial of OCS-01 (Oculis Holding AG) for the treatment of inflammation and pain following cataract surgery at the ASCRS Annual meeting. The results showed that 57.2% of patients treated with OCS-01 were inflammation free (ie, absence of anterior chamber cells) at Day 15 (vs 24.0% with vehicle, p<0.0001) and 75.5% had absence of ocular pain at Day 4 (vs 52.0% with vehicle, p<0.0001). Oculis initiated the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eyedrop in late 2023, and topline readout is expected before the end of 2024. The two Phase 3 OPTIMIZE trials are expected to support an NDA submission.

  • BRILL S.L. announced its entry into the US ophthalmology market with the non-invasive and portable Corneal Esthesiometer Brill. FDA-approved and set to launch in May 2024, the Corneal Esthesiometer Brill will allow ophthalmologists and optometrists to detect early stages of corneal sensation loss, allowing them to prescribe more specific treatments and monitor their effectiveness through a non-invasive and cost-effective diagnostic tool, the company says. The device measures corneal sensitivity, allowing physicians to diagnose, monitor and provide follow-up therapies in multiple pathologies in which the corneal nerves are affected. The device evaluates corneal-nerve status as a useful biomarker in the diagnosis and prognosis of eye health in highly prevalent diseases, such as glaucoma, herpes and dry eye, among others. Additionally, it allows physicians to differentiate stages of diseases such as neurotrophic keratitis, diabetic keratitis and dry eye, and to monitor patients who have undergone refractive surgery or corneal transplants and those who wear contact lenses.

  • West Point Optical Group and Verséa Ophthalmics entered into a partnership supply agreement in which Verséa will be the exclusive provider of its BIOVANCE and BIOVANCE 3L Ocular products. BIOVANCE and BIOVANCE 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix. BIOVANCE 3L Ocular is acellular and consists of three layers of amniotic basement membrane that supports treatment of advanced ocular surface disease. As a barrier membrane, BIOVANCE 3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries. Applications include corneal and conjunctival-related injuries or defects such as corneal epithelial defects, pterygium repair and fornix reconstruction. Terms of the agreement are not disclosed.

  • The FDA cleared Ocugen Inc.’s Investigational New Drug amendment to initiate a Phase 3 clinical trial of OCU400, a modifier gene therapy product candidate being developed for retinitis pigmentosa. The Phase 3 study will have a sample size of 150 participants — one arm of 75 participants with the RHO gene mutation and the other arm with 75 participants that are gene agnostic. In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively. In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing scale was the primary functional endpoint. For the Phase 3 OCU400 clinical trial, an updated mobility course will be used — Luminance Dependent Navigation Assessment — that includes a wider range of light intensity (0.04-500 Lux) and Lux Levels (0-9) with a uniform correlation between Lux level and Lux intensity. 

  • EyeCare Partners (ECP) is launching two new initiatives — the Refractive Cataract Anterior Segment (RCAS) Fellowship and the ECP Foundation. The RCAS Fellowship program is designed to provide a fast-track path for new ophthalmologists. The one-year program provides residency graduates comprehensive training in the latest advancements in refractive cataract and anterior segment surgeries. Beginning in July 2025, the fellowship program will be offered at three ECP practice locations: Virginia Eye Consultants, Cincinnati Eye Institute and Oakland Ophthalmic Surgery. The new ECP Foundation is a 501(c)(3) non-profit organization that supports and furthers the mission of EyeCare Partners to enhance vision, advance eye care and improve lives.

  • Cloudbreak Pharma shared new data from a company-supported survey highlighting the patient burden of pterygium at the annual ASCRS meeting. The cross-sectional survey revealed 50% of respondents reported that pterygium had a considerable impact on their lives, often interfering with their ability to perform daily activities. More than half of patients surveyed also reported that environmental factors such as wind, dry or hot weather, direct sun and pollen exacerbate their symptoms and make it difficult to spend time outdoors. Additionally, patients reported discomfort associated with air conditioning — spending time indoors can also pose a challenge. The survey was conducted in volunteers for a multi-center Phase 3 clinical trial enrolling people with a known pterygium of ≥1.2 mm and conjunctival hyperemia (measured on a scale of 0-4) in the United States. A Phase 2 clinical trial evaluating the safety, efficacy and pharmacokinetics of CBT-001, an investigational multi-kinase inhibitor for the treatment of pterygium, highlighted its potential to reduce lesion length and decrease pterygia vascularity for patients with pterygium. For more, click here.

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.