FDA approves ‘world’s first’ spiral IOL platform

Rayner announced FDA approval of its RayOne Galaxy and RayOne Galaxy Toric IOLs on what it described as the “world’s first spiral IOL platform.” According to the company’s press release the Galaxy is a non-diffractive IOL, designed to deliver a smooth, continuous full range of vision with limited dysphotopsias and “0% loss of transmitted light.” The lens is now commercially available in the U.S.

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Company to submit formal appeal after FDA’s denial of dry eye disease NDA

Aldeyra Therapeutics announced that it is planning to submit a Formal Dispute Resolution Request to the FDA for reproxalap, an investigational drug candidate for the treatment of dry eye disease, which despite three NDA submissions (one initial submission and two resubmissions) was not approved by the FDA. The company expects to submit this appeal in the fourth quarter of this year. The company stated in a press release that “over the course of the three NDA submissions, Aldeyra has provided data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints, consistent with or greater than the success rates of clinical trials conducted for approved dry eye disease products.” The company added that its intention to submit this request is based on two meetings with the FDA.

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FDA to hold Advisory Committee meeting for low-dose atropine treatment for myopia

After the FDA issued a complete response letter last year, denying approval, for SYD-101, a low-dose atropine for treatment of pediatric progressive myopia developed by Sydnexis, the company stated that the FDA is hosting an Advisory Committee meeting with a public hearing on October 30 to review the NDA. This hearing “will give physicians and caregivers the opportunity to share their firsthand experience directly with the advisory committee.” SYD-101 is already approved in the E.U. and U.K.

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Positive results in Phase 3 trial for AMD treatment

Kodiak Sciences announced that it met its primary endpoints in its Phase 3 trial evaluating Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) for treatment of wet AMD. According to the company’s press release, both achieved non-inferiority in visual gains compared to aflibercept at 1 year. The company reported that Zenkuda matched or exceeded the clinical effect of aflibercept and also saw 54% of patients achieving 6-month durability at year 1. The treatments were safe and well tolerated, according to the company. Kodiak plans to submit Zenkuda for approval to regulatory authorities in the fourth quarter of this year.

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Phase 3 trial investigating DME treatment begins

4D Molecular Therapeutics is beginning a Phase 3 trial, enrolling many of its first patients, for treatment of diabetic macular edema (DME) with 4D-150. According to the company’s press release, 4D-150 is aflibercept and anti-VEGF-C. Treatment is composed of a single intravitreal injection with technology that uses a “proprietary Therapeutic Vector Evolution platform, as well as a proprietary transgene payload designed for robust aflibercept expression plus anti-VEGF-C inhibitory RNA.” The Phase 3 trial will enroll 514 treatment-naïve patients with DME. The company stated that all participants will receive five aflibercept loading doses, with aflibercept responsiveness after the first three doses influencing randomization. The primary endpoint is non-inferiority in mean change from baseline in BCVA at week 52. Secondary endpoints include reduced treatment burden and the proportion of participants within a 2-step or greater improvement from baseline in the ETDRS-DRS Scale at week 52.

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Register for the next event, October 8, in New Orleans, Louisiana.
• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.
• ASCRS Foundation: ASCRS National Sight Week, sponsored by STAAR Surgical, takes place the first week of October, with World Sight Day on October 8. Support the sight-restoring work of the ASCRS Foundation’s domestic charitable cataract surgery program, Operation Sight, by making a tax-deductible donation today!

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EyeWorld article of the week

There are now several all-in-one phacovitrectomy machines on the market, but is one appropriate at your surgery center? Read the perspectives from three ophthalmologists in this article in the Fall issue of EyeWorld.

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Research highlights

• A global, cross-sectional epidemiological study has provided a 10-year update to the first survey quantifying corneal transplant tissue supply and demand. The paper published in the journal JAMA Ophthalmology compared findings from global corneal transplant and corneal procurement in 2022 to that in 2012. The study included 122 countries, finding that more than 214,000 corneal transplants were performed in 2022, which was a 16.1% increase compared to the number in 2012. The number of corneal tissue procedures also increased in this timeframe, but it was outpaced by general population growth, meaning there was a decline in per capita tissue procurement rate. The authors concluded that the increase in corneal transplants over 10 years was moderate but noted that the “supply-demand gap remains severe.” They also reported inequity in transplant availability between high- and lower-income countries. “Coordinated investment in eye banking infrastructure in middle-income countries is needed alongside alternative therapies,” they wrote.
• A randomized controlled trial published in the Journal of Cataract & Refractive Surgery studied the effect of varying preset IOP levels in cataract surgery on retinal perfusion in eyes with nonproliferative diabetic retinopathy, as measured with OCT angiography. The study randomized patients 1:1 to either low (20 mm Hg) or high (55 mm Hg) intraoperative IOP. The primary outcome was percent change in central retinal vessel density. Forty eyes of 40 patients were included in each group. There was a statistically significant increase in central retinal vessel density at week 1 and month 1 in the low IOP group, compared to the high group. According to the paper, “reduction in perfusion density in the radial peripapillary capillary region did not differ significantly between groups.” Postoperative IOP was comparable between groups. The authors concluded that a low IOP during cataract surgery in this patient population could be beneficial for the macular and optic nerve head perfusion.

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