FDA advisory committee meets, hears public comments about atropine drop

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee met on October 30 to hear comments from eyecare providers and others regarding SYD-101 (Sydnexis), a low-dose atropine drop that it denied approval last year as a treatment for progressive pediatric myopia, issuing a complete response letter to the company’s NDA. The company had met the primary endpoint in its Phase 3 clinical trial, and there were no issues with the product’s safety or efficacy, but the FDA at the time had said that the data from the study did not support the drop’s efficacy for pediatric myopia. SYD-101 is approved for use in the European Union and the U.K. Read the EyeWorld Online Exclusive recap of the recent FDA meeting with additional physician perspectives regarding SYD-101.

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FDA requires label change on GLP-1s due to ocular risk

The FDA announced that it is requiring a label change to all GLP-1 receptor agonists due to the rare but serious risk of non-arteritic anterior ischemic optic neuropathy (NAION). This information will be added to the Warnings and Precautions section of the labels. GLP-1s are indicated to manage elements of type 2 diabetes but have in recent years become used increasingly among the general population for weight loss. The FDA noted that analysis from 126 randomized controlled trials involving GLP-1s showed an occurrence rate of 6.4 NAION cases per 100,000 people treated with GLP-1s compared to 3.8 NAION cases per 100,000 patients treated with placebo or a non-GLP-1.

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First patient dosed in Phase 1 trial of gene therapy for Stargardt disease

City Therapeutics announced the dosage of the first patient in its Phase 1 trial evaluating CITY-RBP4 as a possible therapy for Stargardt disease type 1. This RNA interference therapy is designed to “silence expression of retinol-binding protein 4 (RBP4) to reduce the delivery of vitamin A to the eye and potentially slow the progression of retinal damage and vision loss associated with Stargardt disease,” according to the company’s press release. Topline data from the first-in-human trial, which is multicenter, randomized, double masked, and placebo controlled, is expected by mid-2027.

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Preclinical program for investigational, first-in-class DED therapy complete

Link Biologics completed its preclinical program, allowing it to move forward with an IND for LB001 (Link_TSG6) as an investigational treatment for moderate to severe dry eye disease (DED). The company’s press release described LB001 as a first-in-class TSG-6-based eye drop that addresses inflammation and ocular surface damage. In the preclinical program, repeat doses of LB001 showed favorable tolerability and minimal systemic exposure, according to the company. The company plans to submit an IND in the first quarter of 2027.

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Company aligns with FDA on Phase 3 program for Stargardt disease therapy

VeonGen Therapeutics announced that it held a successful Regenerative Medicine Advanced Therapy Type B meeting with the FDA to begin its pivotal Phase 3 program evaluating VG801, a dual-AAV gene therapy, for treatment of Stargardt disease and other ABCA4-associated retinal dystrophies. VeonGen and the FDA reached alignment on the study’s design. The company also provided an update from its ongoing Phase 1/2 trial, which has shown “measurable baseline BCVA improvements” in all 13 participants out to month 6 or month 12.

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Company news

• IMVIONIX, a new biotechnology company dedicated to delivering retinal therapies, has launched and announced obtaining exclusive commercial rights to BEOVU (brolucizumab-dbll), a treatment for wet AMD and DME, in the United States and Canada from Novartis.

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ASCRS news and events

• ASCRS Annual Meeting: Hotel rooms are available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location. Meeting registration opens soon.
• SightLine at ASCRS: Mark your calendar for SightLine at ASCRS, which will take place April 1 in San Diego ahead of the Annual Meeting. Registration opens soon.
• ASCRS Foundation: 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

Residual refractive error, such as surgically induced astigmatism, can leave a patient less than satisfied after ophthalmic surgery. Lens choice in these patients can influence residual refractive error, though continual study and innovation have begun to take this into account, with some lenses now being more forgiving to residual refractive error. Francesco Carones, MD, and Karolinne Rocha, MD, PhD, have both researched this topic and share their thoughts in EyeWorld. Read the article.

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Research highlights

• The efficacy and safety of implantable phakic contact lenses (IPCL) compared to implantable collamer lenses (ICL) for myopia correction were assessed via a systematic review and meta-analysis published in the Journal of Cataract & Refractive Surgery. The authors identified and analyzed data from nine studies, three of which were randomized and six observational, that included 1,187 eyes (559 were IPCL and 628 were ICL). The UDVA and CDVA were similar between the groups. There was a small significant difference in favor of IPCL when it came to spherical equivalent, but the authors noted that it was “not robust to sensitivity analysis.” Refractive accuracy and secondary outcomes, such as vault, cataract formation, endothelial cell loss, and explantation rates, were similar among the two options as well. Acute glaucoma did not occur with ICL but did occur with IPCL (0.17%). When it came to astigmatic correction, the authors reported that toric ICLs had better rotational stability. They advocated for more long-term studies comparing the ICL and IPCL.
• The minimal amount of time to use a remote IOP monitor, such as iCare HOME/HOME2 tonometers, was evaluated in a secondary modeling analysis of retrospective data. The research, published in the journal Ophthalmology, included data from participants from the Moran Eye Center, Wilmer Eye Institute, and from the MyEyes Corporation database who used the iCare HOME tonometers, recording at least three measurements each day over their use of the device. According to the authors, 6–7 days were needed to “achieve 95% of the modeled reduction in error for daily mean, maximum, range, and [standard deviation] of IOP in the primary analysis.” Longer monitoring was needed for POAG (9.1–10.0 days) compared to glaucoma suspects (5.5–6.7 days), secondary open-angle glaucoma (6.4–8.0 days), and primary angle-closure glaucoma (7.8–8.3 days). The authors found that monitoring was consistent before and after SLT and implantation of the Hydrus microstent (Alcon). They also found that when IOP measurements were restricted to taking only three per day, it extended monitoring duration time. With this, the authors concluded that “seven to ten consecutive monitoring days consisting of measurements across each day are needed to represent a patient’s true IOP pattern.” They also reported that 74.1% of peak IOP measurements were recorded outside of normal clinic hours.

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Product news

• ZEISS recently received approval in China for its PT LUNANA phakic IOL.
• Tenpoint Therapeutics launched a telehealth prescribing program for YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution), 2.75%/0.1%, for treatment of presbyopia. Participants in the telehealth program are encouraged to establish and maintain care with local eyecare professionals, the company stated.

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