Linear atrophy

Sept. 28, 2022 11:00 UTC ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that its technologies will be featured in various scientific programming at the American Academy of Ophthalmology (AAO) annual meeting, being held September 30 - October 3, 2022 in Chicago, IL. Key Glaucoma Presentations: Bryan CH Ang, MD Novel Use of the Intraoperative OCT in Trabecular Bypass Minimally Invasive Glaucoma Surgery Fritz H. Hengerer, MD Trabecular Micro-Bypass +/- Cataract Surgery Shows 5-Year Efficacy and Safety in Eyes Regardless of Prior Glaucoma Surgery Jed Lusthaus, MBBS Analysis of the Relationship Between IOP and Aqueous Outflow as Assessed by Hemoglobin Video Imaging After Trabecular Bypass Surgery With iStent Inject® Thomas W. Samuelson, MD Endothelial Safety Pro MIGS Stents Inder Paul Singh, MD Trabecular Micro-Bypass for IOP Reduction in Glaucoma Uncontrolled by Prior Surgical or Medical Therapy (Prospective Multicenter Pivotal Trial of iStent Infinite®) Key Glaucoma Course: Steven R. Sarkisian, MD MIGS: Devices and Incisional Techniques Key Glaucoma Symposium: Oluwatosin U. Smith, MD and Qi N. Cui, MD New Devices in Glaucoma Key Corneal Health Presentations: Eric Kim Effectiveness of CXL in Young Patients Katherin S. Peters, MD Racial Disparities in KC: Presentation Severity and Treatment Outcomes Key Corneal Health Courses: J. Bradley Randleman, MD Advanced Corneal Topographic Analysis Audrey R. Talley Rostov, MD Corneal Edema, Opacifications, Ectasia and Bacterial Keratitis: Diagnosis and Treatment Strategies from the Preferred Practice Pattern Guidelines Key Corneal Health Symposium: Loretta Szczotka-Flynn OD, Ph.D. and Mark A. Kontos, MD The Life Cycle of Keratoconus: From Diagnosis to Treatment and Lifetime Management (joint session with the American Academy of Optometry) Abstracts and full session details can be found at . Glaukos will also be exhibiting on the showroom floor throughout AAO at booth #4503. The AAO Annual Meeting is among the largest gatherings of ophthalmic physicians, medical personnel, and industry executives in the ophthalmic industry. All educational content of the AAO Annual Meeting is planned by its program committee, and AAO does not endorse, promote, approve or recommend the use of any products, devices or services. About Glaukos Glaukos ( ) is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases. About iStent inject W Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent inject W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. Contraindications: The iStent inject W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. MRI Information: The iStent inject W is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject W have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. Adverse Events: Common postoperative adverse events reported in the iStent inject randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%). Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events. For more information, visit . About Photrexa® Viscous and Photrexa Indications: Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL® System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Important Safety Information: Corneal collagen cross-linking should not be performed on pregnant women. Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects. The most common ocular adverse reaction was corneal opacity (haze). Other ocular side effects include punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye pain, light sensitivity, reduced visual acuity and blurred vision. These are not all of the side effects of the corneal collagen cross-linking treatment. For more information, go to to obtain the FDA-approved product labeling. Photrexa Viscous and Photrexa are manufactured for Avedro. The KXL System is manufactured by Avedro. Avedro is a wholly owned subsidiary of Glaukos Corporation. Forward-Looking Statements All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety pro our products as might be suggested in the presentations at the AAO meeting. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on August 5, 2022. Our filings with the SEC are available in the Investor Section of our website at or at . In addition, information about the risks and benefits of our products is available on our website at . All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

The preference for minimally invasive spine surgery over traditional open surge treatment procedures drives the growth of the global motion preservation devices market. PORTLAND, Ore., June 27, 2022 /PRNewswire/ -- Allied Market Research published a report, titled, "Motion Preservation Devices Market by Product Type (Dynamic Stabilization Devices, Artificial Discs, Annulus Repair Devices, Nuclear Disc Prostheses Device), by Surgery (Minimally Invasive Spine Surgery, Open Spine Surgery): Global Opportunity Analysis and Industry Forecast, 2020-2030." According to the report, the global motion preservation devices industry generated $1.5 billion in 2020, and is expected to reach $2.8 billion by 2030, witnessing a CAGR of 6.7% from 2021 to 2030. Download Sample PDF at: Drivers, Restraints, and Opportunities The preference for minimally invasive spine surgery over traditional open surge treatment procedures, lower cost of minimally invasive surgical procedures as compared to traditional procedures, and rise in geriatric population drive the growth of the global motion preservation devices market. However, unfavorable reimbursement scenario restrains the market growth. On the other hand, incidences of diseases such as spinal disorders & neurological disorders and advancements in surgical techniques create new opportunities in the coming years. Covid-19 Scenario Owing to reduced open spine surgery procedures, the demand for motion preservation devices decreased considerably. The large number of spinal procedures was postponed in hospitals as they focused on treating increased number of Covid-19 infected patients and postponed non-elective surgeries. According to a study published in the British Journal of Surgery, during 12 weeks of peak disruption in the hospital operations due to COVID-19, nearly 28.4 million elective surgeries were either canceled or postponed in May 2020. This impacted the motion preservation devices market revenue negatively. The open spine surgery segment expected to maintain its lead position throughout the forecast period Based on surgery, the open spine surgery segment accounted for the highest market share in 2020, contributing to nearly three-fifths of the global motion preservation devices market, and is expected to maintain its lead position throughout the forecast period. This is due to various advantages such as reduced cost of the surgery and hospitalization. However, the minimally invasive spine surgery segment is estimated to witness the largest CAGR of 7.4% from 2021 to 2030, owing to increase in the adoption of novel and technologically advanced techniques. Specific Requirement on COVID-19? Ask to Our Industry Expert: The artificial discs segment to maintain its leadership status during the forecast period Based on product type, the artificial discs segment held the highest market share in terms of revenue in 2020, accounting for nearly two-fifths of the global motion preservation devices market, and is projected to maintain its leadership status during the forecast period. This is due to increase in the incidence of spinal impairments. However, the annulus repair devices segment is projected to register the fastest CAGR of 8.0% from 2021 to 2030. This is attributed to rise in aging population. North America to continue to dominate by 2030 Based on region, North America contributed to the highest market share in terms of revenue in 2020, accounting for nearly two-fifths of the global motion preservation devices market. This is due to the presence of major companies and vendors in this region that have focused on product development to serve dual purpose to mitigate the disability rate caused by spinal injuries. However, Asia-Pacific is estimated to manifest the largest CAGR of 8.0% during the forecast period, owing to rise in the prevalence of spinal cord deformities and injuries. Leading Market Players B. Braun Melunsung GlobusMedical, Inc Zimmer Biomet Aurora Spine Corporation HPI Implants Paradigm Spine RTI Surgical, Inc. Raymedica, Inc. Spinal Kinetics, Inc. Ulrich GmbH & Co. KG Avenue Basic Plan | Library Access | 1 Year Subscription | Sign up for Avenue subscription to access more than 12,000+ company profiles and 2,000+ niche industry market research reports at $699 per month, per seat. For a year, the client needs to purchase minimum 2 seat plan. Request for 14 days free trial: "We have also published few syndicated market studies in the similar area that might be of your interest. Below are the report title for your reference, considering Impact of Covid-19 Over This Market which will help you to assess aftereffects of pandemic on short-term and long-term growth trends of this market." 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Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of "Market Research Reports" and "Business Intelligence Solutions." AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain. Pawan Kumar, the CEO of Allied Market Research, is leading the organization toward providing high-quality data and insights. We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry. Contact: David Correa 5933 NE Win Sivers Drive #205, Portland, OR 97220 United States USA/Canada (Toll Free): +1-800-792-5285, +1-503-894-6022 UK: +44-845-528-1300 Hong Kong: +852-301-84916 India (Pune): +91-20-66346060 Fax: +1(855)550-5975 [email protected] Web: Follow Us on LinkedIn: Logo: SOURCE Allied Market Research

Calliditas CEO, Renée Aguiar-Lucander/Photo courtesy of Calliditas Therapeutics IgA nephropathy, or IgAN, is a condition you have probably never heard of. It doesn’t have a parade or a month dedicated to its awareness. It’s not even easy to pronounce. Think: ‘IGA nuh-FROP-uh-thee’. But this orphan disease is one of the main reasons the team at Calliditas Therapeutics goes to work every day. Stockholm, Sweden-based Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN. On April 28, Calliditas announced that the U.S. Food and Drug Administration (FDA) had accepted the submission of its new drug application (NDA) and granted priority review for Nefecon, bringing the drug one step closer to becoming the first medicine specifically designed and approved for IgAN. IgAN, also known as Berger's disease, is a progressive autoimmune kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, causing inflammation that can lead to the kidney’s inability to filter waste from the blood. There is currently no approved treatment for IgAN, and 25-30% of patients go on to develop end-stage renal disease within 20 years of their diagnosis, condemning them to years of dialysis or the need to undergo a kidney transplant. “I think it is really a patient group, as in many orphan diseases, that feel that they have been a bit forgotten,” said Calliditas chief executive officer, Renée Aguiar-Lucander. Based on the results of Part A of Calliditas’ NefIgArd pivotal Phase III study, it is no mystery why the company received priority review for this promising therapy in a condition for which there is currently no approved treatment. In the trial, which assessed the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN, the therapy met its primary endpoint, demonstrating significant reduction of urine protein creatine ratio after 9 months of treatment at a 16mg dose level. The patients continued to improve at 12 months. Nefecon also had a significant impact on the key secondary endpoint, estimated glomerular filtration rate (EGFR), a key indicator of the kidney’s ability to filter creatine. “That EGFR continues to decline for these patients, month after month and year after year until they end up in dialysis or transplantation. We know that the vast majority of these patients end up in dialysis and they haven’t even turned 50, so they’re young,” Aguiar-Lucander explained. Results from the NefIgArd trial found that the EGFR continued to decline in the placebo group, while in the treatment group, the drop-off ceased. “You can see in the clinical data that there is this kind of kidney protective effect. The vast number of people on this treatment do not have any further kidney deterioration. That is obviously great because it shows that there’s a way to hopefully keep these patients out of dialysis and transplantation in the long run,” Aguiar-Lucander said. In an effort to treat IgAN, physicians often prescribe blood pressure-lowering agents like ACE inhibitors, which aim to reduce the pressure on the damaged filter mechanisms and enable the kidney to better clean waste from the blood. Aguiar-Lucander explained that, while helpful, these drugs primarily provide symptomatic relief. Calliditas, on the other hand, is directly targeting the origin of the disease. “All other drugs presently in development for IgAN have a systemic approach and effect. Calliditas is the only product candidate which is focused on the origin of the disease and hence has a local approach targeting the Peyer’s patches which produce galactose deficient IgA antibodies, thus interrupting the disease process at its origin,” Aguiar-Lucander said. Nefecon leverages the TARGIT technology, developed by West Pharmaceutical Services, which allows it to pass through the stomach and intestine on its way to the targeted small intestine. “We're taking a very different route to how we're coming at this disease,” Aguiar-Lucander explained. “We're not doing anything systemically. We're not trying to focus on the kidney when the damage is already done. We’re really trying to avoid having the damage occur in the first place, or to really delay and stop that kind of damage.” In terms of safety, Nefecon benefits from the established profile of budesonide. “It’s very typical of this kind of budesonide profile. It's been in man for quite a long time, so it is very well established. We know a lot about the substance; we know how it behaves, we know what it does,” Aguiar-Lucander said. She added that while side effects such as transitory acne and stria can occur, “you're not really seeing any clinical effects on the metabolic system or the cardiovascular system. You're not seeing any severe infections, so you're avoiding a lot of the kind of effects that people worry about.” While the confirmatory Part B of the NefIgArd study assessing long-term renal benefit is not expected to read out until 2023, Calliditas has applied for accelerated approval based on an exception that allows drugs targeting conditions with serious unmet needs to be approved based on a surrogate endpoint. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. If approved, Nefecon would become the first commercial success for Calliditas. “I think a lot of people spend a lot of time in biotech and life sciences and don’t have the opportunity to get a drug to the patient,” Aguiar-Lucander said. “We’re all super excited about being able to do that.”