Graybug Reports a Switch in Patient Dose in Phase IIb ALTISSIMO Trial
Graybug Vision provided preliminary topline data from its Phase IIb ALTISSIMO trial of GB-102, a microparticle depot formulation of sunitinib malate injected intravitreally, for the treatment of wet age-related macular degeneration. The trial was originally designed to evaluate two separate doses of GB-102, 1 mg and 2 mg, injected every six months as compared with aflibercept injected every two months. Based on the results of an interim safety analysis, the company discontinued use of the 2 mg dose was after the initial dose, and all patients were switched to 1 mg for their second dose, as the 1 mg dose performed better than the 2 mg dose overall, Graybug says. Read more.
Second Sight Gets FDA Nod for Argus 2s Retinal Prosthesis System
Second Sight Medical Products announced the FDA approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa. Read more.
Teva Launches Generic Version of Azopt
Teva Pharmaceuticals launched the first generic version of Azopt (brinzolamide ophthalmic suspension) 1%, approved by the FDA to treat ocular hypertension and open-angle glaucoma.
Oculus Pentacam AXL Wave Receives FDA Clearance
The new Oculus Pentacam AXL Wave—which features retroillumination and a Hartman-Shack sensor for total eye wavefront and objective refraction, in addition to established functions of anterior segment tomography and optical biometry—received FDA 510(k) clearance. It incorporates reports with network compatibility and full operability of all Pentacam software and exams. The company says the measuring process is fast and patient-friendly, and a guide allows both eyes to be examined in less than five minutes. In addition, the new device comes with an overview display showing all parameters for corneal screening, IOL power selection, IOL power calculation, ICL selection and calculation, and pupil diameter under dimmed and dark conditions. Read more.
Complimentary CME Education Videos
Lutronic Vision Treats First AMD Patient in R:GEN Clinical Trial
Lutronic Vision treated the first early-stage age-related macular degeneration patient in its clinical trial evaluating the R:GENTM laser. The single-arm, open-label pilot study will enroll approximately 30 early-stage AMD patients who will be treated with R:GENTM, and evaluated at 24 and 48 weeks. Read more.
CiRC Biosciences Announces Orphan Drug Designation for RP Treatment
CiRC Biosciences announced the FDA granted Orphan Drug Designation for chemically induced photoreceptor-like cells (CiPCs) for the treatment of retinitis pigmentosa. The company is advancing pre-clinical development of CiPCs for vision restoration in advanced RP and geographic atrophy age-related macular degeneration; CiRC says its novel technology enables direct chemical transdifferentiation of fibroblasts into other cell types using a cocktail of small molecules in a chemical conversion process that takes less than two weeks. Learn more.