Phase 3 results for new corticosteroid

Oculis announced Phase 3 results for OCS-01, a corticosteroid in development as a once-daily topical to treat pain and inflammation after ocular surgery. Results from one Phase 3 study were presented at the recent ASCRS Annual Meeting. According to the company’s press release, OCS-01 in the first Phase 3 study resulted in 57.2% of patients being inflammation-free at day 15, compared to 24% who were inflammation-free with vehicle. In addition, 75.5% treated with the investigational drug were free from pain at day 4 compared to 52% with vehicle. The company stated that results from a second Phase 3 study will be available by the end of this year with the intent of supporting an NDA submission to the FDA.

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Positive topline results from Phase 3 trials investigating presbyopia drop

LENZ Therapeutics announced positive topline results from its Phase 3 studies investigating two formulations of aceclidine for treatment of presbyopia. According to the company, its lead formulation LNZ100 (1.75% aceclidine) achieved primary and secondary endpoints with 71% of patients achieving 3 lines or greater improvement in near vision 30 minutes after instillation, 71% achieving 3 lines or greater improvement of near vision at 3 hours (primary endpoint), and 40% achieving 3 lines or greater improvement at 10 hours. LNZ101 showed similar results but was not superior to LNZ100, which was well tolerated with no serious treatment-related adverse events. The company plans to submit an NDA by mid-2024 for LNZ100.

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Phase 2 data presented for IOP-lowering intracameral implant

Ocular Therapeutix announced that Phase 2 data was presented at the ASCRS Annual Meeting for its travoprost intracameral implant (PAXTRAVA). The data showed a statistically significant 24–30% reduction in IOP from baseline through 6 months. What’s more, 81.3% of treated eyes did not require additional IOP-lowering therapy during the 6 months post-implant. According to the company’s press release, the implant was well tolerated with no observed impact on corneal health. The company is planning to seek a meeting with the FDA to finalize development for its Phase 3 trials.

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First patient dosed in retinitis pigmentosa gene therapy

ViGeneron announced that the first patient has been dosed in its Phase 1b clinical trial evaluating VG901 as therapy to treat retinitis pigmentosa caused by the CNGA1 gene. According to the company’s press release, VG901 is administered via the intravitreally delivered vgAAV platform, which it noted “[mitigates] the risk of retinal damaged linked with subretinal administration.” The investigational therapy has an Orphan Drug Designation from the FDA. The trial is ongoing, open label, single arm, and dose escalating to investigate safety, tolerability, and preliminary efficacy of VG901.

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Survey shows burden of pterygium

Cloudbreak Pharma shared data at the ASCRS Annual Meeting that found 50% of respondents in a survey who had pterygium said it had a significant impact on their lives and their ability to perform daily activities. According to the company’s press release, more than half of patients said environmental factors exacerbated their symptoms and made it difficult to spend time outdoors. Indoor air conditioning can cause discomfort as well. The company is developing an investigational multi-kinase inhibitor (CBT-001) to treat pterygium; it’s currently in Phase 3 trials to determine if it can slow or stop progression and potentially eliminate or postpone surgery.

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ASCRS news and events

• ASCRS Annual Meeting: Hotel blocks are now open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025. If you were not at the 2024 ASCRS Annual Meeting, review onsite coverage in EyeWorld Daily News.
• ASCRS Live!: This new dinner series, making its way to nine cities, is continuing to bring ASCRS education around the U.S. See where it’s heading next.

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Research highlights

• The complications that resulted in IOL explantation or secondary interventions were evaluated in a survey study published in the Journal of Cataract & Refractive Surgery. According to the paper, this is the 25th consecutive year that surgeons were surveyed regarding complications associated with foldable IOLs that required explantation or secondary intervention. The survey was completed by 103 surgeons in 2022 (for a total of 1,627 completed surveys since 2007). Dislocation and decentration continued to be the most common complication in the 2022 survey. The authors noted glare and other optical aberrations being a common complication with multifocal lenses. Hydrophilic acrylic IOL material and some silicone lenses showed calcification that necessitated explantation, though the authors noted this complication was rare.
• DMEK as a treatment for interface fluid syndrome (IFS) in post-LASIK patients was described in the journal Cornea. The paper involved three cases in which patients developed IFS many years after LASIK. DMEK was performed, and postop patients showed resolution of corneal edema and improved BCVA. The authors concluded that “DMEK can provide successful visual and anatomical recovery in patients who have had previous LASIK and experience late-onset IFS due to endothelial cell dysfunction.”

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Product news

• The LAL+, the Light Adjustable Lens developed by RxSight based on the original lens platform but with a modified aspheric anterior surface for an increase in central lens power, began its commercial launch.
• iDose TR (Glaukos) received a permanent J-code (J7355), which will become effective on July 1.

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