Keratoconus

DENVER, May 13, 2024 (GLOBE NEWSWIRE) -- ArcScan, Inc., a global medical technology company dedicated to helping ophthalmologists improve vision with ultra-high frequency ultrasound diagnostic images, announced today that ArcScan Insight® 100 has received National Medical Products Administration (NMPA) approval in China. “We believe the ArcScan Insight® 100 will help eyecare surgeons in China to better address the myopia epidemic which is predicted to affect 5 billion people globally by 2050 according to the journal Ophthalmology,” stated Andrew Levien, ArcScan CEO. “Surpassing the limitations of optical coherence tomography (OCT), our ultrasound solution provides comprehensive visualization of the anterior segment to help surgeons identify anatomical artifacts that could contribute to substandard post-surgical outcomes.” Using Insight® 100, eye surgeons can more accurately determine the appropriate sizing of phakic intraocular lenses (pIOL’s) for placement behind the iris for treatment of myopia, commonly known as nearsightedness. According to the 2024 Global IOL Market Report published by Market Scope Reports, the leading market research provider for the eyecare industry, phakic IOL procedures will surpass 780 thousand procedures globally in 2024, with a projected growth rate of 8.8 percent from 2024 to 2029. “The Insight® 100 has significantly improved outcomes for my patients,” shared Robert Lin, MD, founder and CEO, IQ Laser Vision, California. “The most precise epithelial mapping technology with accuracy down to 1 um allows me to better assess the risk of keratoconus. Better visualization into the anterior segment and reproducible, easy and precise measurement of the sulcus, where the posterior phakic IOL (EVO ICL, Staar and pICL) allows better sizing of the pIOL to reduce potential risks of lens rotation, glaucoma and cataracts.” About ArcScan Insight® 100 ArcScan, Inc.’s Insight® 100 is a computer-controlled high-frequency ultrasound device designed to equip ophthalmologists with precise, detailed images of the anterior segment of the eye. The Insight® 100 has been granted FDA marketing clearance, CE approval and NMPA Certification and has been the subject of dozens of studies demonstrating the validity and applicability of computer-controlled ultrasound imaging. Within academic, military and private clinics and institutions worldwide, applications continue to grow, complementing OCT limitations with precision ultrasonic imaging behind the iris. ArcScan, Inc. is headquartered in Denver, Colorado and has 19 patents surrounding its unique approach to ophthalmic imaging and additional patient applications in process. For more information about ArcScan, Inc. and Insight® 100, please visit . REFERENCES: National Medical Products Administration (NMPA): Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. PMID: 26875007. (16)00025-7/fulltext CONTACT: Karen Lundquist klundquist@arcscan.com A photo accompanying this announcement is available at ARCSCAN INSIGHT® 100 OPHTHALMIC ULTRASOUND IMAGING SYSTEM ArcScan, Inc.’s Insight® 100 is a computer-controlled high-frequency ultrasound device designed to equip ophthalmologists with precise, detailed images of the anterior segment of the eye.

The surge in demand for corneal implants stems mainly from the rise in instances of corneal blindness, eye injuries, and conditions like ocular hypertension (glaucoma). Moreover, the growing collaboration among industry stakeholders to innovate in corneal implant technology, alongside the limited availability of cornea donors, is anticipated to drive the expansion of the corneal implant market from 2024 to 2030. LAS VEGAS, April 23, 2024 /PRNewswire/ -- DelveInsight's Corneal Implant Market Insights report provides the current and forecast market analysis, individual leading corneal implant companies' market shares, challenges, corneal implant market drivers, barriers, trends, and key market corneal implant companies in the market. Key Takeaways from the Corneal Implant Market Report As per DelveInsight estimates, North America is anticipated to dominate the global corneal implant market during the forecast period. Notable corneal implant companies such as EyeYon, AJL Ophthalmic S.A., KeraMed, Inc., Aurolab, CorneaGen, Presbia PLC, LinkoCare Life Sciences AB, MEDIPHACOS, Cornea Biosciences, Advancing Sight Network, Corneat Vision, DIOPTEX, and several others, are currently operating in the corneal implant market. In July 2022, Acufocus received FDA approval for AcuFocus' IC-8 Apthera. IC-8 Apthera is indicated for the treatment of cataract patients. In July 2019, CorneaGen received USD 37 million in funding for the advanced development of Cornea Cell Therapy. To read more about the latest highlights related to the corneal implant market, get a snapshot of the key highlights entailed in the Global Corneal Implant Market Report Corneal Implant Overview Corneal implants, also known as corneal inlays, are innovative devices designed to correct refractive errors such as presbyopia, a condition where the eye's ability to focus on nearby objects diminishes with age. These tiny implants are placed within the cornea, the transparent front part of the eye, to enhance its optical properties and improve vision. Unlike traditional eyeglasses or contact lenses, corneal implants offer a more permanent solution with minimal maintenance, providing individuals with clear vision and freedom from dependency on corrective eyewear. The procedure for inserting corneal implants is relatively quick and minimally invasive, often performed on an outpatient basis. By carefully reshaping the cornea's curvature, these implants can restore near vision, allowing individuals to read, work on computers, and perform other close-up tasks without difficulty. With advancements in technology and materials, corneal implants continue to evolve, offering promising outcomes for those seeking long-term vision correction without the inconvenience of glasses or contacts. Corneal Implant Market Insights In 2023, North America dominated the corneal implant market, primarily due to the presence of key industry players in the region. Favorable reimbursement policies, heightened research and development efforts focused on corneal implants, and the escalating burden of corneal blindness all contribute to this growth trend. Data from the Centers for Disease Control and Prevention (CDC) in 2022 revealed that around 6 million Americans experienced vision loss and 1 million suffered from blindness in 2017. The prevalence of risk factors like diabetes and hypertension, as highlighted in the CDC's National Diabetes Statistics Report of 2020, further exacerbates ocular disorders. With approximately 34.2 million Americans diagnosed with diabetes in 2020 and another 88 million displaying pre-diabetic conditions, the demand for corneal implants is expected to rise as ophthalmic disorders become more prevalent. Additionally, North America benefits from significant product development and partnership initiatives within the corneal implants sector. Notably, in July 2022, Carl Zeiss Meditec and Precise Bio announced a collaboration aimed at developing and commercializing tissue-based implants, underscoring the region's dynamic corneal implant market landscape. To know more about why North America is leading the market growth in the corneal implant market, get a snapshot of the Corneal Implant Market Outlook Corneal Implant Market Dynamics The corneal implant market has been witnessing dynamic shifts driven by technological advancements, the rising prevalence of eye disorders, and increasing awareness about treatment options. Technological innovations such as advanced materials, improved surgical techniques, and customizable implants are revolutionizing the landscape, offering patients more effective and tailored solutions. Additionally, the growing aging population and lifestyle changes leading to conditions like myopia and astigmatism are fueling demand for corneal implants globally. Moreover, strategic collaborations between healthcare institutions, research organizations, and industry players further propel market growth. These partnerships facilitate the development of novel products, streamline regulatory processes, and expand corneal implant market reach. Furthermore, the adoption of minimally invasive procedures and outpatient surgeries is driving market expansion by reducing patient recovery time, lowering healthcare costs, and enhancing overall patient satisfaction. However, challenges such as stringent regulatory requirements, limited reimbursement policies, and the high cost of advanced implants pose barriers to corneal implant market growth. Overcoming these hurdles requires concerted efforts from stakeholders to streamline regulatory frameworks, increase insurance coverage, and invest in research and development to bring down costs. Despite these challenges, the corneal implant market is poised for steady growth as technological innovations continue to improve treatment outcomes and expand the scope of therapeutic options for patients with corneal disorders. Get a sneak peek at the corneal implant market dynamics @ Corneal Implant Market Dynamics Analysis Corneal Implant Market Assessment Corneal Implant Market Segmentation Corneal Implant Market Segmentation By Procedure: Endothelial Keratoplasty, Penetrating Keratoplasty, and Others Corneal Implant Market Segmentation By Disease: Keratoconus, Fuchs Dystrophy, Infectious Keratitis, Corneal Ulcers, and Others Corneal Implant Market Segmentation By End User: Hospitals, Eye Clinics, and Ambulatory Surgical Centers Corneal Implant Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the corneal implant market are set to emerge as the trendsetter explore @ Corneal Implant Companies Table of Contents Interested in knowing the corneal implant market by 2030? Click to get a snapshot of the Corneal Implant Market Trends Related Reports Fuchs Endothelial Corneal Dystrophy Market Fuchs Endothelial Corneal Dystrophy Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key FECD companies, including Kowa Pharmaceuticals, Trefoil Therapeutics, ProQR Therapeutics, and Emmecell, among others. Keratoconus Market Keratoconus Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key keratoconus companies, including Glaukos, Avedro, Glaukos Corporation, Sooft Italia, Lightmed OptiMed, Peschke Meditrade GmbH, iVeena Delivery Systems, among others. Keratitis Market Keratitis Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key keratitis companies, including Merck & Co, Bausch Health, Gilead Biosciences, Pfizer, and Glenmark Pharmaceuticals, among others. Corneal Ulcer Market Corneal Ulcer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key corneal ulcer companies, including DompéFarmaceutica, Claris Biotherapeutics, ReGenTree, LLCR, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

LYNX-2 Follows SPA Agreement with FDA Development of PS is Funded by Ocuphire’s Partner Viatris April 11, 2024 -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery. The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). As previously announced, Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial would adequately address objectives supporting regulatory submission and a potential future marketing application in this indication. “We are pleased to begin enrollment in the LYNX-2 study of PS,” said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire. “If our registration program meets expectations, and PS is subsequently approved by the FDA, it could potentially be the first commercial treatment for patients who have undergone LASIK surgery and experience low light visual disturbances. We believe that PS is a product with broad potential applications in ophthalmology. Having already received approval for RYZUMVI™ to treat pharmacologically-induced mydriasis, our partner Viatris, Inc. (Viatris) now has the opportunity to create further value as it pursues additional indications for PS, which also include presbyopia.” Vision disturbances under low light conditions are characterized by peripheral corneal imperfections (aberrations) that result in unfocused light when the pupil dilates under low light conditions. Patients experience decreased low contrast visual acuity as well as glare, halos and starbursts. Patients undergoing keratorefractive surgery (including LASIK, PRK, SMILE, and RK) have been identified as one of the major sub-populations affected, the others being those who have night myopia (naturally occurring), non-central cortical cataracts, keratoconus or post-multifocal or extended depth of focus intraocular lens (IOL) implantation. There are currently no FDA-approved treatments for visual disturbances under low light conditions. With a mechanism of action that moderately reduces pupil size without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle, PS eye drops have the potential to be a treatment option that could improve patients’ ability to see and function in low light. The previous LYNX-1 Phase 3 study evaluating PS successfully met its primary endpoint, with 13% of subjects gaining 15 or more ETDRS letters of mesopic low contrast distance visual acuity at Day 8 vs. 3% on placebo (phttps://www.ocuphire.com/news-media/press-releases/detail/374/ocuphire-announces-positive-topline-results-from-lynx-1. Jay Pepose, M.D., PhD., Chief Medical Advisor at Ocuphire, commented, “Low light vision disturbances are characterized by difficulty in distinguishing objects with subtle differences in contrast, such as a pedestrian in a crosswalk at dusk or on a rainy day under low light conditions. This represents a significant, yet often overlooked sequela of LASIK or other forms of keratorefractive surgery. Despite the success and popularity of LASIK for vision correction, a subset of patients find themselves grappling with these low light or night-time vision challenges, for which there has been no specific, targeted treatment available. If approved, PS offers the potential to enhance visual performance in low light conditions and restore a sense of normalcy and confidence in these patients.” Ocuphire has a global license agreement with Viatris to co-develop and commercialize PS for the reversal of mydriasis, presbyopia and low light vision disturbances. Under the terms of this agreement, the two companies agreed to co-develop the product for each of these conditions, with Viatris providing funding for development of these programs. Further, Ocuphire is eligible to receive specified regulatory or net sales milestone payments associated with these indications as well as royalties on commercial sales. In September 2023, Ocuphire met the $10 million milestone payment requirements attributed to the FDA’s approval of PS for reversal of mydriasis. LYNX-2 is a randomized, double-masked, placebo-controlled Phase 3 registration study designed to evaluate the safety and efficacy of PS compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions. The trial is expected to enroll 200 subjects. The primary endpoint, agreed with the FDA under the SPA, will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. Additional information about the Phase 3 trial can be found at www.clinicaltrials.gov. Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders. Ocuphire’s lead retinal product candidate, APX3330, is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) for the treatment of non-proliferative diabetic retinopathy (NPDR). Ref-1 is a regulator of the transcription factors HIF-1α and NF-κB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of diabetic retinopathy (DR). A Phase 2 study in subjects with DR and an End-of-Phase 2 meeting have recently been completed, and a SPA is planned to be submitted. In addition, Ocuphire has a partnership with Viatris to develop and commercialize Phentolamine Ophthalmic Solution 0.75% (PS), a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI™ in September 2023. As discussed above, PS is also in Phase 3 clinical development for the treatment of presbyopia and for the treatment of decreased visual acuity under low light (mesopic) conditions after keratorefractive surgery. Ocuphire is also developing APX2009 and APX2014, second-generation analogs of APX3330. These programs are being evaluated for treating other retinal diseases such as age-related macular degeneration and geographic atrophy. For more information, please visit www.ocuphire.com. The content above comes from the network. if any infringement, please contact us to modify.