Rayner announced U.S. commercial availability and Food and Drug Administration approval of its RayOne Galaxy and RayOne Galaxy Toric intraocular lenses, marking what the company described in a press release as the world’s first spiral IOL platform. The non-diffractive lenses are engineered to provide a continuous full range of vision while limiting dysphotopsias and maintaining zero percent loss of transmitted light.
Regulatory Submissions and Advisory Hearings for Ophthalmic Therapeutics
Aldeyra Therapeutics announced plans to submit a Formal Dispute Resolution Request to the FDA in the fourth quarter for reproxalap, an investigational dry eye disease treatment that faced three rejections across initial and resubmission filings. The company stated that its trial program included nine adequate and well-controlled clinical studies, five of which met all multiplicity-controlled primary endpoints. Sydnexis reported that the FDA will host an advisory committee meeting with a public hearing on October 30 to review the new drug application for SYD-101, a low-dose atropine for pediatric progressive myopia that received a complete response letter last year. Sydnexis noted that the public hearing will allow physicians and caregivers to share direct experience with the committee, while noting the therapy is already approved in the European Union and United Kingdom.
Kodiak Sciences Phase 3 treatments meet primary endpoints
Kodiak Sciences announced that its Phase 3 evaluations of Zenkuda, also known as tarcocimab tedromer, and tabirafusp-ted for wet age-related macular degeneration met their primary endpoints. Both treatments achieved non-inferiority in visual gains compared to aflibercept at one year, with Zenkuda matching or exceeding the clinical effect of aflibercept and showing 54% of patients achieving six-month durability at the one-year mark. Kodiak plans to submit Zenkuda for regulatory approval in the fourth quarter. Meanwhile, 4D Molecular Therapeutics commenced a Phase 3 trial for diabetic macular edema using 4D-150, a single intravitreal injection combining a proprietary therapeutic vector evolution platform and a transgene payload for aflibercept expression and anti-VEGF-C inhibitory RNA. The trial enrolls 514 treatment-naïve patients, with a primary endpoint measuring non-inferiority in mean change from baseline best-corrected visual acuity at week 52.
Corneal transplants increase over ten years
A global, cross-sectional epidemiological study published in JAMA Ophthalmology provided a ten-year update on corneal transplant supply and demand. Comparing findings from 2022 to 2012 across 122 countries, the study recorded more than 214,000 corneal transplants performed in 2022, representing a 16.1% increase over the decade. In professional education, the American Society of Cataract and Refractive Surgery scheduled its next Live! educational dinner for October 8 in New Orleans, and opened hotel bookings for its 2027 annual meeting in San Diego. The ASCRS Foundation marked National Sight Week during the first week of October to support Operation Sight, its domestic charitable cataract surgery initiative.
What powers RayOne Galaxy lenses and supports reproxalap?
What specific technology powers the newly approved RayOne Galaxy lenses?
According to Rayner, the lenses operate on what the company described as the world’s first spiral IOL platform as a non-diffractive design built to deliver a continuous full range of vision with zero percent loss of transmitted light.
How many clinical trials supported Aldeyra Therapeutics’ regulatory filings for reproxalap?
Aldeyra Therapeutics stated that it provided data from nine adequate and well-controlled clinical trials over the course of three NDA submissions, with five trials achieving all multiplicity-controlled primary endpoints.
What is the primary endpoint for the 4D-150 Phase 3 trial in diabetic macular edema?
According to 4D Molecular Therapeutics, the primary endpoint is non-inferiority in mean change from baseline best-corrected visual acuity at week 52 among 514 treatment-naïve participants.
How many corneal transplants were recorded globally in 2022 according to the JAMA Ophthalmology study?
The global cross-sectional study of 122 countries found that more than 214,000 corneal transplants were performed in 2022, marking a 16.1% increase compared to 2012 figures.
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