Genentech Initiates Phase III Trial Investigating PDS for DR
Genentech initiated a Phase III clinical trial investigating the Port Delivery System with ranibizumab for people with diabetic retinopathy. PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months. Pavilion, a Phase III, multicenter, randomized study, will evaluate the efficacy, safety and pharmacokinetics of PDS for the treatment of DR in people without diabetic macular edema. The primary endpoint of Pavilion is the percentage of patients who achieve a two-step or greater improvement in DR severity from baseline at week 52, as measured by the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale. Read more on Pavilion.
Topcon Announces the U.S. Launch of Aladdin-M
Topcon Healthcare launched its new Aladdin-M instrument to the U.S. market. Aladdin-M combines corneal topography, pupillometry and optical biometry to enable objective measurement of corneal curvature, pupil dynamics and axial length metrics. The device provides tools to support myopia management in addition to features for keratoconus screening and contact lens fitting, Topcon says. Learn more.
FDA Approves Drug for Rare Disorder
The U.S. Food and Drug Administration recently approved Genentech's drug Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Read more.
Zeiss Updates IOLMaster 700 Software
Zeiss says the new software for the IOLMaster 700 (1.90) has enhanced features and connectivity designed to improve cataract surgeons’ workflow efficiency. The update includes central topography, access to surgical planning data on mobile devices with EQ Mobile from ZEISS, and the Barrett True K with Total Keratometry formula. Read more.
FDA Approves Cystadrops for Ocular Manifestations of Cystinosis
Recordati Rare Diseases announced that the FDA has approved Cystadrops (cysteamine ophthalmic solution) 0.37%—a new viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis, a rare genetic condition that leads to the build-up of cystine crystals throughout the body, causing widespread tissue and organ damage and significant impact on the eyes. Cystadrops is the first FDA-approved cysteamine drop formulation with q.i.d. dosing, the company says. Read more.
BVI Expands Malosa Single-use Instrument Range
BVI announced the extension of its Malosa range of single-use ophthalmic instruments in the United States. The Malosa portfolio, which now includes specialty instruments for use in corneal refractive surgery, complements the company’s single-use products for cataract, oculoplastic and office-based procedures such as LASIK, PRK and SMILE. Learn more.
Quantel Launches Mosar Imaging System
Quantel Medical launched Mosar, a new optional imaging system, dedicated to the Easyret yellow retinal laser. Mosar is composed of an HD camera, a screen and a computer. Designed to enhance retinal laser treatment procedures and patient follow-up, Quantel says the new imaging system offers a user-friendly software interface. Read more.
Ocular Therapeutix Resolves FDA Warning Letter Related to ReSure Sealant, Announces Third MAC to Establish New Published Physician Fee Schedule for Intracanalicular Insert Administration
Ocular Therapeutix received a letter from the FDA closing out an FDA warning letter received October 18, 2018, concerning ReSure Sealant. The original warning letter was based on the observed inability to conduct a study evaluating endophthalmitis rates following ReSure use in a post-approval Device Exposure Registry study required under 21 CFR 814.82(a)(2) as a condition of a premarket approval application. It was determined that the ability to enroll a study evaluating endophthalmitis rates was prohibitively challenging due to the size of the study, which would have required tens of thousands of patients. The company reached an agreement with the FDA to conduct a retrospective study looking at sites with access to ReSure compared to those without access to ReSure using the Iris Registry data base. Read more.
The company also announced that National Government Services, one of seven Medicare Administrative Contractors, became the third MAC to establish a physician fee schedule for procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including the company’s insert, Dextenza (dexamethasone ophthalmic insert) 0.4 mg, effective July 1. Read more.
AMA Issues CPT Category III Codes for Artificial Iris Implantation
VEO Ophthalmics announced the American Medical Association issued three separate CPT codes for the "insertion of iris prosthesis." The CPT Category III codes, 0616T, 0617T and 0618T, were effective July 1. Earlier this year, the CustomFlex ArtificialIris was approved by the CMS for transitional pass-through payment status, effective January 1. The HCPCS code for the CustomFlex ArtificialIris associated with pass-through payment is C1839: Iris prosthesis. Read more.
Prevent Blindness Launches “Glaucoma Community”
Prevent Blindness and Responsum Health launched The Glaucoma Community, a new platform that can be accessed for free via web browser or mobile app, to educate the public on glaucoma, and offer resources to patients and caregivers. The Glaucoma Community was made possible by a grant from The Allergan Foundation. Special features include: a personalized newsfeed, a community chat, a moderated social wall, automatic translation into seven languages and Patient One-Sheet, which allows patients to collect, maintain and print their key medical information in a secure format. Read more.