Gyroscope Receives FDA Fast Track Designation for GT005
Gyroscope Therapeutics announced the FDA granted Fast Track designation to GT005 for the treatment of geographic atrophy secondary to dry age-related macular degeneration. GT005, an investigational one-time AAV-based gene therapy delivered under the retina, is intended to slow the progression of GA. It is targeted to individuals with specific mutations in their Complement Factor I (CFI) gene and low levels of the CFI protein in their blood. Read more.
Apellis Announces Pegcetacoplan Analysis Accepted at EURETINA 2020
Apellis Pharmaceuticals announced that a post hoc analysis of the Phase II FILLY study investigating intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration was accepted as a late-breaking oral presentation by EURETINA 2020 Virtual. The new analysis demonstrates that pegcetacoplan impacts the progression of nascent GA in areas of the retina outside of GA lesions. Read more.
Bausch Health to Acquire Option to Purchase Allegro’s Ophthalmology Assets
Bausch Health Companies announced that Bausch Health (through its affiliate) entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro, including global rights for risuteganib (Luminate). The integrin-regulating therapy is believed to reduce mitochondrial dysfunction involved in intermediate dry age-related macular degeneration. Other ophthalmology assets of Allegro include ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye. The option payment totaling $50 million would be made in two tranches. Read more.
FDA Accepts Emmetrope Ophthalmics' IND Application for EO2002
Emmetrope Ophthalmics announced the FDA accepted its Investigational New Drug application for EO2002, its lead candidate for the treatment of corneal edema. The active IND enables Emmetrope to initiate a Phase I clinical trial to assess the tolerability, safety and efficacy of EO2002 in individuals with corneal edema. EO2002, a first-in-class, non-surgical, magnetic cell-based therapy, was developed by Emmetrope through its exclusive Magnetic Cell Delivery nanoparticle platform. Read more.
Second Sight Resumes Orion Study
Second Sight Medical Products’ Early Feasibility Study of the Orion Visual Cortical Prosthesis System at UCLA Medical Center has resumed. The study was paused for in-person visits following guidelines for clinical trials in March due to COVID-19. Orion is intended to provide useful artificial vision to individuals who are blind due to a range of causes, the company says. It converts images captured by a miniature video camera mounted on glasses into small electrical pulses transmitted wirelessly to electrodes implanted on the brain’s visual cortex. Read more.