Novartis Reports Positive Phase III Results for RTH258
Novartis reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints of non-inferiority compared with Regeneron’s Eylea (aflibercept) for treatment of neovascular age-related macular degeneration (AMD). The results were from two Phase III studies, HAWK and HARRIER. HAWK also evaluated the 3-mg RTH258 formulation, which also met these endpoints. The pivotal studies enrolled more than 1,800 patients across 400 centers worldwide. The endpoints involved mean change in best-corrected visual acuity from baseline to week 48, and average mean change over weeks 36 to 48. The results also showed RTH258 was well tolerated with overall ocular and non-ocular (systemic) adverse event rates comparable to Eylea.
Encouraging Top-line Safety Data for AGTC XLRS candidate
Applied Genetic Technologies Corporation (AGTC) reported top-line safety data for the dose-escalation phase of its Phase I/II, X-linked retinoschisis (XLRS) clinical trial, a program partnered with Biogen. Clinical investigator Mark Pennesi, MD, PhD, of Oregon Health and Science University Casey Eye Institute, presented data at the Macula Society annual meeting in Singapore that showed that for the first 12 subjects enrolled, most had mild to moderate ocular inflammation that resolved or was controlled either without further intervention or after treatment with topical or oral corticosteroids. No treatment-related serious adverse events were reported and the treatment was generally well tolerated. AGTC’s portfolio focuses on human clinical trials of adeno-associated virus (AAV)-based gene therapies.
Mynosys Gets FDA Clearance for Zepto Capsulotomy System
Mynosys Cellular Devices received 510(k) clearance from the US Food and Drug Administration for the Zepto Capsulotomy System for cataract surgery. Zepto uses a proprietary combination of calibrated suction and a 4-millisecond multi-pulse energy algorithm to produce highly accurate capsulotomies. Mynosys has partnered with Precision Lens of Bloomington, MN, to distribute the platform. US launch is planned for August 1.
J&J Vision Names Dr. Jonathan Talamo CMO
Former Ocular Therapeutix CMO Jonathan Talamo, MD, has taken the same title with Johnson & Johnson Vision Care and added worldwide vice president of medical affairs and clinical affairs to his nameplate. The unit comprises J&J’s vision care and surgical businesses. Before he joined Ocular Therapeutix, Dr. Talamo owned a private medical practice for almost 20 years, specializing in refractive surgery, cataract surgery, and corneal transplantation.
Alcon Gets Boost in CheckedUp Partnership
CheckedUp has expanded its existing partnership with Alcon to incorporate content about Alcon surgical products and technologies into the CheckedUp platform for educating patients about cataract surgery. The CheckedUp platform comprises four components for engaging patients: interactive kiosks (CheckedUp Engage); a 26-inch exam-room wallboard (CheckedUp Consult); a patient-outreach module via mobile device or computer (CheckedUp Reach); and an analytics dashboard physicians and staff can access (CheckedUp Manage).