510(k) clearance granted to pattern scanning laser indirect ophthalmoscope

Norlase announced that it received 510(k) clearance from the FDA and the CE mark for its Norlase LYNX pattern scanning laser indirect ophthalmoscope and subsequently began its commercial launch of the battery-powered, untethered laser ophthalmoscope. According to the company’s press release, the device is worn as a headset for ergonomic benefits and includes features like multilingual voice control.

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12-week safety, efficacy results for wet AMD therapy

Outlook Therapeutics announced 12-week safety and efficacy results for the second of its clinical trials evaluating ONS-5010 (bevacizumab), finding it to be non-inferior to ranibizumab for treatment of wet AMD. The difference in mean BCVA between ONS-5010 and ranibizumab was –1.009, according to the company’s press release. The company reported a mean 5.5 letter BCVA improvement in the ONS-5010 arm and a 6.5 letter improvement in the ranibizumab arm. The treatment was well tolerated, and ocular adverse events were comparable to those that occurred with ranibizumab. Based on these results, according to the company’s press release, Outlook plans to resubmit its Biologics License Application to the FDA within the first quarter of this year. It had previously not met its pre-specified, special protocol assessment non-inferiority endpoint at week 8. The company noted, however, that this recent data shows that “across all study timepoints [ONS-5010] demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.”

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Phase 3 trial for dry eye treatment complete

Stuart Therapeutics announced that it completed the last patient visit for its Phase 3 trial for ST-100 (vezocolmitide) for treatment of dry eye disease. The randomized, double-blind, vehicle-controlled trial investigated safety, tolerability, and efficacy of the ST-100 treatment compared to placebo for 1 week followed by a 2-week observation period. Topline results will be announced in February. According to the company’s press release, vezocolmitide is a “collagen mimetic peptide that selectively repairs disease-damaged collagen in the eye.”

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Corneal implant company moves toward PMA submission

Pantheon Vision announced its third meeting with the FDA as it moves forward with its pre-clinical and clinical work for a Premarket Approval (PMA) submission for its corneal implant candidate, which seeks to reduce reliance on donor tissue needs.

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Update on neuropathic corneal pain trial

OKYO Pharma provided an update on its Phase 2a trial of OK-101 for treatment of neuropathic corneal pain. According to the company’s press release, enrollment of the 48-patient trial will end in the second quarter of 2025, and topline results are expected by the fourth quarter. The 12-week trial is double masked, randomized, and placebo controlled.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the Preview Program here.
• The Winning Pitch Challenge: The Winning Pitch Challenge ahead of the ASCRS Annual Meeting will be back on April 24 in Los Angeles, California. Submissions for innovative ideas that could impact the future of eyecare are being accepted now through February 14. Cash prizes for winners are worth up to $25,000. Find more information on submissions here.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• Femtosecond laser arcuate keratotomy (FSAK) or toric IOLs for astigmatism correction at the time of cataract surgery were compared in a randomized clinical trial conducted at a single site in China between 2021 and 2023. Patients in the study had 0.75–3.00 D of corneal astigmatism and were randomized 1:1 for the astigmatic correction interventions (n=90 in the femtosecond AK group and n=98 in the toric IOL; 92 and 95 patients, respectively, completed the 3-month follow-up period). At 3 months postop, the authors reported “no difference in the refractive astigmatism between the two groups.” Subgroup analysis, however, “showed that TIOL implantation achieved lower residual astigmatism compared with FSAK when treating astigmatism exceeding 1.5 D or against-the-rule astigmatism.” The authors concluded that for patients with mild to moderate astigmatism having femtosecond laser cataract surgery, femtosecond AKs were not superior to toric IOLs, and more specifically, toric IOLs resulted in better outcomes for patients with 1.5 D of astigmatism or against-the-rule astigmatism. This paper is published in JAMA Ophthalmology.
• The postop endophthalmitis rates and risk factors after secondary IOL implantation for aphakia or IOL exchange, with or without vitrectomy, among Medicare fee-for-service beneficiaries in the U.S. from January 1, 2011, through November 19, 2022, were evaluated in a retrospective study published in the Journal of Cataract & Refractive Surgery. The study included 97,152 patients and identified a 42-day postop endophthalmitis rate for secondary IOL implantation for patients with aphakia of 0.35% and IOL exchange of 0.28%. Endophthalmitis rates were 0.31% and 0.30% when combined with posterior vitrectomy for aphakia and IOL exchange, respectively; when combined with anterior vitrectomy, the rates were 0.84% and 0.42%, respectively. The authors concluded that the overall endophthalmitis risk for all secondary IOL procedures was 0.31%. They wrote that they “hypothesize that the absence of the posterior capsular barrier would explain the higher [postoperative endophthalmitis] rates compared with cataract surgery, especially if a concurrent vitrectomy was performed with the secondary IOL procedure.”

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Product news

• Apellis Pharmaceuticals announced approval of SYFOVRE (pegcetacoplan) in Australia for the every-other-month treatment of geographic atrophy with an intact fovea when central vision is threatened by lesion growth.
• ARCATUS (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) by Clearside Biomedical/Arctic Vision received approval in Australia and Singapore for treatment of uveitic macular edema.

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