Small-aperture IOL receives FDA approval

The IC-8 Apthera IOL by AcuFocus has received FDA approval. The company’s press release said that Apthera, with its small-aperture technology, is the first and only non-toric EDOF IOL approved for patients who have up to 1.5 D of corneal astigmatism. According to the company, the FDA approval is based on data that showed the safety and efficacy of the Apthera IOL compared to a monofocal or monofocal toric implanted in the fellow eye. The study enrolled 453 subjects who were followed for 12 months (343 received Apthera in one eye and 110 received monofocal or monofocal torics in both eyes). The company reported that eyes with Apthera maintained 2 D of EDOF and 0.91 D of additional range of vision benefit compared to the control group at the 0.2 logMAR threshold. UCDVA was equivalent in the patients with Apthera compared to control and statistically superior at intermediate and near vision distances compared to control. Binocular contrast sensitivity between the two groups in photopic and mesopic conditions were similar. A limited commercial release of Apthera in the U.S. will begin in the fall of 2022.

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First patient enrolled in new LASIK trial

Bausch + Lomb announced that it has enrolled its first patient in a safety and efficacy study of its Technolas TENEO excimer laser for LASIK for hyperopia with astigmatism. According to the company’s press release, this study will inform possible FDA approval for this device (the laser is already available in some markets outside the U.S.). The multicenter, prospective, single-arm, open-label, non-randomized study will enroll up to 334 eyes undergoing LASIK for hyperopia and hyperopic astigmatism with up to 24 months of follow-up, the press release reported.

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Safety of sustained-release intravitreal implant confirmed

Alimera Sciences announced data from its Phase 4 study that confirms the long-term safety of ILUVIEN (fluocinolone acetonide intravitreal implant) for patients with DME. According to the company’s press release, this 3-year, real-world observational study showed that this sustained-release intravitreal implant reduces the frequency of DME recurrence and that there is a benefit of using a corticosteroid prior to the implant to lower risk of uncontrolled IOP spikes. The data, according to the company, also showed visual improvement, reduction in treatment burden, and retinal thickness variability.

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Dosing complete in Phase 1/2a trial for injectable wet AMD therapy

Clearside Biomedical completed dosing in its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) for patients with wet AMD. This safety and tolerability study of a single dose of CLS-AX as a suprachoroidal injection enrolled 27 patients in four cohorts with escalating doses, the company reported in its press release. Safety and tolerability will be assessed at 3 months. An ongoing extension study will continue for an additional 3 months for patients in cohorts 2–4. In addition to safety and tolerability, pharmacokinetics, visual function, ocular anatomy, and need for additional aflibercept within the study period will be assessed. According to the press release, final data is expected in the fourth quarter of 2022.

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First patient dosed in light-activated optogenetic monotherapy study

Nanoscope Therapeutics dosed its first patients in a Phase 2 trial of its multi-characteristic opsin (MCO-010) ambient-light activatable optogenetic monotherapy for Stargardt disease. This study, according to the company’s press release, will enroll about six patients who will receive the same dose. Six-month safety and efficacy data is expected within the first quarter of 2023.

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Phase 2 study for investigational new immunomodulator to treat dry eye disease

Yuyu Pharma announced enrollment of the first patient in its Phase 2 study of YP-P10, a novel, synthetic peptide with anti-inflammatory and wound-healing properties to treat patients with dry eye disease. The study will be conducted at seven U.S. sites and will enroll 240 patients. According to the company, preclinical data showed that YP-P10 was a more active immunomodulator than lifitegrast, lowering pro-inflammatory cytokines and chemokines.

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Partnership created to develop tissue implant therapies

Carl Zeiss Meditec and Precise Bio have partnered to develop and commercialize fabricated corneal tissue for transplant in patients needing endothelial keratoplasty or treatments for keratoconus and vision correction. Under the terms, according to the press release, Carl Zeiss Meditec will invest in Precise Bio and fund development of the two corneal transplant products. Carl Zeiss Meditec will have exclusive, worldwide commercialization rights for the products. The press release described that Precise Bio uses engineering, biomaterials, cell technology, bioengineering, and 3-D printing to create a 4-D bio-fabrication platform for transplantable organs and tissues.

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ASCRS news and events

• ASCRS Summer Meeting: Register for the ASCRS Summer Meeting to get a “Taste of ASCRS”—its focused, anterior segment CME and in-person experience—August 19–21, in Nashville, Tennessee.
• Ophthalmology Quicksand Chronicles: Episode 3 of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, is now online.

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Research highlights

• A cohort study published in JAMA Ophthalmology investigated whether there was an association between diabetes medication and eye diseases like open-angle glaucoma, AMD, and cataract development. The study, which included 11,260 participants of European ethnicity, ultimately found that treatment with metformin was associated with lower risk of primary open-angle glaucoma, while other types of diabetes medications were associated with lower risk of AMD. There was no association found between diabetes medication and cataract development. The authors suggested further clinical trials to confirm causality between diabetes medication and reduced risk for glaucoma and AMD.
• In what the authors described as the “first study to evaluate management strategies for [patients] presenting with advanced glaucoma,” investigators performed a within-trial economic evaluation to compare medical and surgical management strategies of glaucoma. The cost utility analysis used data from the U.K. National Health Service and found that trabeculectomy was associated with higher costs and a greater effect on quality of life within the first 2 years postop. The authors concluded that at 2 years, medication “appears more cost effective,” but they advocated for future research to evaluate the costs and benefits of treatments over a longer timeframe. This study was published in the British Journal of Ophthalmology.

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Product news

• TYRVAYA (varenicline solution nasal spray, Oyster Point) is now covered by additional commercial prescription drug plans, expanding patient access.

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