J&J Vision Announces Approval of Tecnis Synergy and Tecnis Synergy Toric II
Johnson & Johnson Vision announced the FDA approval of Tecnis Synergy and Tecnis Synergy Toric II IOLs. The company says the next-generation PCIOL, built on the legacy Tecnis platform, delivers the widest range of continuous vision with the best near vision among leading PCIOLs, superior contrast even in low-light conditions, and reduced spectacle wear. In a company-sponsored study, nine out of 10 patients who received TECNIS Synergy IOL lenses didn’t need glasses after surgery. Read for more information and references.
AGTC Reports Positive Data from Ongoing XLRP Trial
Applied Genetic Technologies, a biotechnology company conducting human clinical trials of adeno-associated virus-based gene therapies for the treatment of rare retinal diseases, reported additional positive data from the ongoing X-linked retinitis pigmentosa (XLRP) Phase I/II clinical trial. This included 12-month data from groups 5 and 6, reflecting a 50-percent response rate among patients who met the inclusion criteria for the Skyline and Vista trials, and 24-month data from two of three group-4 patients, providing preliminary evidence of response durability. The third patient was not a responder at month 12, and no early data are available for the remaining four group-4 patients. Read more.
Novartis Phase III Beovu Data Show Potential for Fluid Resolution
Novartis announced positive one-year results of the Phase III KESTREL and KITE studies, evaluating the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema. Both studies met their primary endpoints of non-inferiority in change in best-corrected visual acuity from baseline for Beovu 6 mg vs. aflibercept 2 mg at year one. Read more.
OpRegen Demonstrates Improvements in Patients with Dry AMD with GA
Lineage Cell Therapeutics announced that updated interim results from its Phase I/IIa clinical study of lead product candidate OpRegen were reported at the Association for Research in Vision and Ophthalmology annual meeting, held virtually May 1 to 7. Data were presented on 24 patients, including all 12 treated in cohort 4, which showed better baseline vision and smaller areas of GA than earlier cohorts. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space for the treatment of dry age-related macular degeneration with geographic atrophy. Read more.
OWL Announces Development and Networking Program for Executives
Ophthalmic World Leaders, an organization dedicated to promoting and developing diverse leadership to advance ophthalmic innovation and patient care, announced its inaugural Get-On-Board with OWL program. Primarily aimed at executive-level women and underrepresented communities, this offering will help attendees develop the skills and connections required to secure board positions in a rapidly changing corporate environment. Learn more and register.
FDA Analysis of Endophthalmitis Rates with ReSure Sealant
Ocular Therapeutix received notification from the FDA confirming it fulfilled all post-approval study requirements for ReSure Sealant, with a requirement to update the ReSure label reflecting the study results. As a condition for ReSure’s pre-market approval application in 2014, the FDA required two post-approval studies to be completed. Read more.
Refractive Surgery Council Reports Nearly 30 Percent Rise in Laser Vision Correction Procedures
The Refractive Surgery Council, which helps consumers make informed choices about their vision correction options, reported that the start of 2021 had a nearly 30 percent rise in laser vision correction procedures over 2020. More than 220,000 LASIK, SMILE and PRK procedures have been performed so far this year, reflecting demand fueled by a renewed consumer focus on self-care and safety. Learn more about the Council.
Verana Leads Study Showing Promise of Real-world Data in Ophthalmic Clinical Development
Verana Health unveiled research during the virtual Association for Research in Vision and Ophthalmology Annual Meeting demonstrating it was able to successfully use real-world data to replicate primary outcome measures of two large-scale randomized controlled trials in ophthalmology—the VIEW 1 and VIEW 2 pivotal trials. Read more.
J&J Vision Presents New Data at ARVO Annual Meeting
Johnson & Johnson Vision presented nearly 30 posters and papers of research data on myopia, intraocular lenses, phacoemulsification, refractive surgery and meibomian gland dysfunction at the virtual Association for Research in Vision and Ophthalmology Annual Meeting held from May 1 to 7. View a list of the presentations.
Complimentary CME Education Videos