Faricimab Extends Time Between Treatments in Two Phase III studies
At this year’s American Diabetes Association Virtual 81st Scientific Sessions (June 25 to 29), Genentech is presenting primary results from two Phase III trials of its investigational bispecific antibody faricimab for diabetic macular edema. Faricimab is the first treatment that targets dual pathways to control the growth of new blood vessels, the company says. More than half of all patients who received faricimab had extended time between treatments to 16 weeks at one year—which Genentech says is the first time this level of durability has been achieved in a Phase III DME study. No new safety signals were identified. Additionally, researchers will present the design of two Port Delivery System studies, which further highlight how treatment burden may be lessened for patients.
B+L Extends Power Range for Toric Multifocal
Presbyopic patients with higher-than-usual astigmatism have had to rely on custom-fit contact lenses if they wanted to try that modality—until now. Bausch + Lomb is expanding the cyl powers on the company’s Ultra Multifocal for Astigmatism, adding powers of -2.25 D and -2.75 D to the range. According to the company, the lenses have been designed for optimal comfort, clarity and stability, along with the convenience of same-day in-office fitting during the initial exam. The cylinder power parameters now include -0.75, -1.25, -1.75, -2.25 and -2.75 D options. The other parameters remain unchanged: a sphere range of -6.00 D to +4.00 D with low- and high-add power varieties. The lenses are made of samfilcon A material, and have a base curve of 8.6 mm and a diameter of 14.5 mm. Read more.
J&J Vision’s Tecnis Synergy and Tecnis Synergy Toric II IOLs Available for Sale
Johnson & Johnson Vision announced the availability of Tecnis Synergy and Tecnis Synergy Toric II IOLs in the United States and Canada. The company says the lenses combine the best of extended-depth-of-focus and multifocal technologies to “deliver the widest range of continuous vision and the best near vision among leading PC-IOLs, without the visual gaps seen with some existing multifocal technologies.” View associated references and read more.
FDA Accepts Application for Genentech’s Port Delivery System With Ranibizumab for Treatment of Wet AMD
Genentech announced the FDA accepted its Biologics License Application, under Priority Review, for Port Delivery System with ranibizumab for the treatment of neovascular age-related macular degeneration. If approved, the company’s PDS would be an alternative to frequent injections of anti-vascular endothelial growth factor. The FDA is expected to make a decision on approval by Oct. 23. Read more.
Gemini Announces Initial Data From Phase IIa GEM103 Study
Gemini Therapeutics announced initial data from its Phase IIa ReGAtta study of GEM103 in patients with geographic atrophy secondary to dry AMD. The company says that GEM103 continued to be well-tolerated with no serious adverse events as of May. There were no early discontinuations due to the study drug. ReGAtta is a dose escalation trial of GEM103, intravitreally administered recombinant human complement factor H, in dry AMD patients. Read more.
Nanoscope Gets FDA Nod for IND for Phase IIb Trial
Nanoscope Therapeutics announced that it will be starting a Phase IIb clinical trial of MCO-010, an ambient-light activatable optogenetic monotherapy to restore vision in patients with advanced retinitis pigmentosa. Read more.
Clearside Announces Safety Results from Cohort 1 of OASIS
Clearside Biomedical announced positive safety results from cohort 1 of OASIS, its ongoing Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector in six patients (n=6) with neovascular age-related macular degeneration. Clearside says the primary endpoints were achieved in cohort 1, as the initial lowest planned dose of 0.03 mg CLS-AX was well-tolerated with no serious adverse events and no drug-related treatment emergent adverse events. Read more.
Gyroscope, Children’s Medical Research Institute to Develop Novel Gene Therapy Capsids
Gyroscope Therapeutics announced the company entered a research collaboration with Children’s Medical Research Institute in Australia to develop next-generation clinical capsids, the protein shells of viral vectors used to deliver gene therapies. A team of researchers from CMRI and Gyroscope will work together in the design and screening of capsid libraries to identify novel capsids for enhanced delivery of ocular gene therapies. Read more.
TelScreen Introduces EyeRes Diamond System Slit Lamp
TelScreen introduced the EyeRes Diamond System, which the company says provides slit-lamp imaging that is “closer to human eye resolution.” The digital imaging system offers a new camera with 137 million pixels per square inch, more than 3.3x the resolution of the Platinum system and within 11 percent of matching the human eye, TelScreen says. Learn more.
ScienceBased Health Ophthalmology Clinical Advisory Panel
ScienceBased Health welcomed the following experts to its ophthalmology clinical advisory panel: Kendall Donaldson, MD, MS, professor of clinical ophthalmology and medical director of Bascom Palmer Eye Institute; Preeya Gupta, MD, associate professor of ophthalmology at Duke University School of Medicine, Durham, NC; Cathleen McCabe, MD, FACS, cataract and refractive surgeon at The Eye Associates, Bradenton, Fla.; Laura M. Periman, MD, director of dry eye services and clinical research at Periman Eye Institute, Seattle; George Waring, IV, MD, FACS, founder and director of Waring Vision Institute, Mount Pleasant, S.C.; and Elizabeth Yeu, MD, partner at Virginia Eye Consultants and assistant professor of ophthalmology at Eastern Virginia School of Medicine, Norfolk, Va.
Marco Partners with Olleyes
Marco Ophthalmic entered into a distribution agreement with Olleyes, a purveyor of virtual reality ophthalmic products. Effective immediately, Marco will add the Olleyes VisuALL S VRP (Virtual reality Platform) into its existing portfolio of ophthalmic medical devices. The VisuALL is the latest commercially available virtual reality visual field analyzer that can be used in clinical practice to help detect glaucoma and to evaluate other ocular diseases. Learn more.
Optomed Offers Disposable Eye Cup
Optomed USA has made a disposable eye cup, the Optomed E-Safe, available for use with the company’s handheld fundus cameras, eliminating the need for a disinfection protocol for that aspect of the device. The eye cup is attached to the camera’s eyepiece, which rests against the patient during imaging. Learn more.
Allegro Names New Executives
Allegro Ophthalmics announced that William J. Link, PhD, was appointed chairman by the company’s board of directors and that Stephanie Yee was named vice president of finance. Dr. Link is founder and principal of Flying L. Partners and is a founder and managing director of Versant Ventures. Read more.
New Treatment for VKC Arrives
A new prescription treatment for vernal keratoconjunctivitis—a rare and recurrent form of ocular allergy sometimes referred to as “morning misery”—is now available in the United States. Verkazia (Santen), a 0.1% cyclosporine ophthalmic emulsion eye drop, received FDA approval for use in children and adults. The company says its oil-in-water cationic emulsion provides improved bioavailability of cyclosporine.
In two randomized, multicenter, double-masked, vehicle-controlled clinical trials, Verkazia demonstrated improvement in corneal inflammation and ocular itching. Adverse events included eye pain (12 percent and eye pruritus (8 percent). The company notes that these events were usually transitory and occured during instillation. For information, visit santenusa.com or santen.com