Byooviz Biosimilar Now Available in the United States
Biogen and Samsung Bioepis launched Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), in the United States. Byooviz will be commercially available starting July 1 through major U.S. distributors. The list price will be $1,130 per single use vial to administer 0.5 mg via intravitreal injection, which is 40 percent lower than the current list price of Lucentis, according to the companies. The FDA approved Byooviz in September 2021 to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Read more.
Novartis Gets FDA Nod of Beovu Treatment for DME
The FDA approved Beovu (brolucizumab-dbll) 6 mg for the treatment of diabetic macular edema, based on year one data from the Phase III, randomized, double-masked KESTREL and KITE studies. The companies say the studies met their primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline vs. aflibercept at year one. Learn more.
CorneaGen Grafts Recalled
The FDA and CorneaGen have announced that the company is recalling the entire lot of Scleral Patch Grafts obtained from lot number W419221008338 because the grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT, and were shipped prior to being medically cleared. Read more.
Apellis Submits NDA to the FDA for Pegcetacoplan
Apellis Pharmaceuticals announced the company submitted a New Drug Application to the FDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for the treatment of geographic atrophy secondary to age-related macular degeneration. The NDA submission is based on results from the Phase III DERBY and OAKS studies at 12 and 18 months, and the Phase II FILLY study at 12 months. The FDA decision on NDA filing acceptance is expected in August 2022. Read more.
Luxa Bio Announces First Participant Dosed in Phase I/IIa Trial of RPESC-RPE-4W
Luxa Biotechnology announced transplantation of cell product RPESC-RPE-4W into the first participant with dry age-related macular degeneration in its Phase I/IIa clinical trial. Read more.
B+L Launches Biotrue Hydration Plus Multi-Purpose Solution in United States
Bausch + Lomb announced the U.S. launch of Biotrue Hydration Plus Multi-Purpose Solution. The new contact lens solution, which is formulated with bio-inspired ingredients, is designed to provide more moisture on lenses, excellent cleaning and a triple disinfectant system that helps deliver effective disinfection, the company says. Learn more.
Alcon to Acquire Eysuvis & Inveltys
Alcon signed an agreement to acquire Eysuvis (loteprednol etabonate suspension) 0.25% pharmaceutical eye drops from Kala Pharmaceuticals. As part of the agreement, Alcon will also acquire Inveltys (loteprednol etabonate suspension) 1%, a corticosteroid for twice-a-day treatment of postoperative inflammation and pain following ocular surgery. Read more.
Aerie Announces First Participant Dosed in Phase III AR-15512 Trial
Aerie Pharmaceuticals announced the first participant was dosed in the Phase III COMET-2 study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye. COMET-2 is the first of three trials in the program for AR-15512. Read more.
• Neurophth Therapeutics appointed Xiaoning Guo, PhD, as chief medical officer. Read more.
• Applied Genetic Technologies formed a scientific advisory board of experts in age-related macular degeneration. View the inaugural members.
New Data from GEMINI Glaucoma Study
Sight Sciences recently announced publication of data from its GEMINI study of the Omni Surgical system used in conjunction with cataract surgery. In 159 patients, the company says the procedure significantly reduced unmedicated mean diurnal intraocular pressure, medication use and daily fluctuations in IOP in patients with open-angle glaucoma. Read more.
Prevent Blindness Announces Call for Nominations, Will Host Annual Focus on Eye Health National Summit
The National Center for Children’s Vision and Eye Health at Prevent Blindness issued a call for nominations for the eighth annual Bonnie Strickland Champion for Children’s Vision Award. Learn more.
In addition, Prevent Blindness will host the 11th annual Prevent Blindness Focus on Eye Health National Summit July 13 to 14, as a virtual event. Learn more.