Prospective trial reveals impact of home OCT in wet AMD management

Notal Vision announced the publication of the “first-ever” prospective trial that used home OCT (SCANLY) as part of the management of wet AMD. According to the company’s press release, the trial enrolled 15 patients diagnosed with wet AMD in at least 1 eye for a total of 21 eyes included in the study. The eyes were managed with home OCT for 6 months. Patients did not receive training on how to use the device in the physician’s office but were provided with virtual support and patient education. The scans they obtained (on average 6.2 per week per eye) were automatically uploaded and reviewed by study investigators. According to the company, use of the home OCT system significantly reduced office visits and treatment frequency (the mean treatment interval went from 15.3 weeks to 8 weeks) while visual acuity remained stable. The study is published in the journal Retina.

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Devices receive FDA 510(k) clearance

Alcon announced that two new systems—the UNITY Vitreoretinal Cataract System and the UNITY Cataract System—received 510(k) clearance from the FDA. These devices, according to the company’s press release, are the first introduced within the company’s Unity portfolio of surgical equipment and will begin broad commercialization in 2025. Both technologies include more workflow efficiencies.

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Review date set for BLA for treatment of macular telangiectasia type 2

Neurotech Pharmaceuticals announced that the FDA has set a PDUFA goal date of December 17 for the Biologic License Application (BLA) of NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia type 2. The company described NT-501 as an ocular implant designed to deliver sustained doses of ciliary neurotrophic factor to the retina to slow this disease.

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FDA grants IND to gene therapy for patients with geographic atrophy

4D Molecular Therapeutics announced that the FDA gave clearance to its Investigational New Drug (IND) Application for 4D-175, which is an R100 vector-based intravitreal gene therapy for treatment of geographic atrophy. According to the company, its Phase 1 GAZE clinical trial will assess the therapy in patients with geographic atrophy as part of a dose exploration stage. Patients will receive one of three doses with safety and tolerability assessed. Enrollment is expected to begin later this year.

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Acquisition news

ANI Pharmaceuticals signed a definitive agreement to acquire Alimera Sciences. Alimera’s assets, specifically ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg and YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, according to ANI Pharmaceutical’s press release, would expand ANI’s “foothold in key strategic therapeutic area of ophthalmology.”

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ASCRS news and events

• Ophthalmology Quicksand Chronicles—Eureka Moments! This ASCRS podcast with hosts Nicole Fram, MD, and Elizabeth Yeu, MD, is back for its fourth season. Watch the first episode with guest Sumit “Sam” Garg, MD.
• ASCRS Business of Refractive Cataract Surgery Summit: ASCRS is introducing a new course that will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients on their refractive surgery journey. Learn more.
• ASCRS Live! The next stop for the ASCRS Live! dinner series, which is bringing education and networking events to several U.S. cities in 2024, is Washington, D.C., July 18. Register now.
• ASCRS Annual Meeting: The call for abstract submissions is now open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.
• 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

• A prospective, randomized, controlled clinical trial published in the Journal of Cataract & Refractive Surgery sought to determine the effect of patient-selected music on patient-reported anxiety and amount of sedative used during cataract surgery. Patients were randomized into a group with music played or a control group with no music; patients were blinded to the study’s purpose. The study included 107 patients with no difference in baseline anxiety between the two randomized groups. Patients who listened to music had significantly lower total, self-reported anxiety (mean 5.98) compared to the control (mean 7.13) and reported feeling less frightened, nervous, and confused. There was, however, not a significant difference in the number or dose of sedatives given to patients in either group.
• A retrospective cohort study published in JAMA Ophthalmology sought to determine the efficacy of selective antibiotic use combined with 1% povidone iodine in preventing endophthalmitis compared to routine use of intracameral antibiotics combined with 5% povidone iodine. Incidence data was from the endophthalmitis registry at Rotterdam Eye Hospital. The investigators found the incidence of postop endophthalmitis in 56,598 cataract surgeries between 2016 and 2022 was 0.000. They conducted a PubMed literature search through September 2023, identifying 37 publications for an endophthalmitis incidence of 0.000 with routine antibiotic prophylaxis. They concluded that there was no difference between postop endophthalmitis incidence at the Rotterdam Eye Hospital and that within published literature. They wrote that disinfection with 1% povidone iodine in combination with selective antibiotic prophylaxis “may be equally effective as routine antibiotic use and 5% povidone iodine.”

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Product news

• Harrow announced the first of three commercial-scale process performance qualification (PPQ) batches for TRIESENCE (triamcinolone acetonide injectable suspension), 40 mg/mL; the second and third PPQ batches are scheduled. If specifications are met, the company reported the new TRIESENCE production process will be complete for a relaunch of the product possible this year.

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