Phase 2 trial with experimental geographic atrophy treatment shows preservation of visual function

Annexon Biosciences announced topline Phase 2 results from its trial evaluating ANX007 in patients with geographic atrophy. According to the company, the study showed statistically significant, dose-dependent preservation of visual function after the 12-month treatment period. In the study, patients were treated either monthly with ANX007 or every other month. Those treated monthly showed a 72% reduction in risk of 15-letter loss, while patients in the every other month group saw a 48% reduction in risk; the pooled patient population had a 59% reduction in a more than 15-letter loss risk. There was a 6.2% reduction in lesion growth in the monthly treatment group and a 1.3% reduction in the every other month group; the pooled patient population saw a 3.7% reduction in lesion growth. The treatment was well tolerated in both treatment groups. The company stated that these data “represent the first demonstration of a complement-based therapy to protect against vision loss in a prospective, 12-month clinical trial” with this therapy, which is designed to preserve photoreceptor cells, synapses, and function.

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AI-enabled screening system receives FDA clearance

iHealthScreen announced FDA 510(k) clearance for its iPredict System, which uses AI-enabled software to detect age-related macular degeneration. According to the company’s press release, iPredict uses AI to analyze high-resolution color fundus images. The company stated that this testing takes 5 minutes with results available within 60 seconds. This technology already has CE clearance and approval from the Australian Health Therapeutic Goods Administration, the company reported.

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Enrollment complete for study evaluating investigational first-line therapy for DME

Alimera Sciences announced that enrollment of approximately 300 patients is complete for its randomized, controlled, multicentered clinical trial that will evaluate ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg as a first-line, baseline therapy for patients with diabetic macular degeneration (DME). According to the company, ILUVIEN will be compared to standard of care treatment (repeated aflibercept anti-VEGF injections). The company’s press release described this study as “the largest head-to-head comparison of any corticosteroid therapy and anti-VEGF therapy” in patients who are newly diagnosed with DME. In the study, patients will be randomized to receive either 5 injections of 2 mg aflibercept at 4-week intervals for the first 16 weeks or the ILUVIEN intravitreal implant. After the first 16 weeks, both arms will be evaluated every 4 weeks and will receive supplemental intravitreal injections of aflibercept if needed. The primary outcome is mean number of supplemental aflibercept injections between the two groups. Early data is expected in 2025.

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Updates from two retinitis pigmentosa trials

Two companies working on treatments for retinitis pigmentosa have provided recent updates from their trials. Coave Therapeutics announced positive 12-month results from its Phase 1/2 trial evaluating the gene therapy CTx-PDE6b for retinitis pigmentosa caused by bi-allelic mutations in the PDE6b gene, supporting a future registrational trial. The investigational gene therapy has been administered to 17 patients with an advanced form of this retinitis pigmentosa, with the more advanced eye receiving the treatment and the other serving as a control, according to the Coave press release. The company also announced regulatory approval to expand this trial with a cohort of younger patients at earlier disease stages. Nacuity Pharmaceuticals announced that it reached target enrollment for its Phase 1/2 clinical trial of NPI-001, an investigational treatment for retinitis pigmentosa associated with Usher syndrome. According to Nacuity’s press release, NP1-001 is delivered in tablet form. The randomized, placebo-controlled, multicenter, double-masked, dose-escalation trial enrolled 48 patients 18 years and older. It is taking place at four sites in Australia. Interim data is expected by the end of 2023.

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ASCRS news and events

• ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Early bird registration pricing is ongoing through June 26.
• Cataract Awareness Month: June is Cataract Awareness Month. Follow ASCRS on social media to keep up with the latest on this important awareness effort.

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Research highlights

• Clinical outcomes between enhanced and conventional monofocal IOLs were compared in a double-masked, prospective, randomized controlled trial published in the Journal of Cataract & Refractive Surgery. The study included 66 adults with corneal astigmatism less than 1.5 D and an axial length of 21–27 mm. These patients were randomized to receive bilateral enhanced monofocal IOLs (ICB00, Johnson & Johnson Vision) or a conventional monofocal (ZCB00, Johnson & Johnson Vision). Emmetropia was targeted in both eyes. According to the authors, those who received the enhanced monofocal gained one additional line of intermediate visual acuity; there was no significant change in CDVA or quality of vision between the two groups.
• A consensus group from the European School for Advanced Studies in Ophthalmology published its guidelines for presbyopia-correcting IOLs. The group considered preoperative elements, IOL selection, and intraoperative and postoperative considerations. The recommendations made in the consensus guidelines, published in the American Journal of Ophthalmology, for use of a diffractive multifocal IOL were potential postop visual acuity of more than 0.5, keratometry between 40–45 D, pupil larger than 2.8 mm under photopic conditions and smaller than 6.0 mm under scotopic conditions, and a root mean square of corneal HOAs less than 0.5 microns for a 6 mm pupil size. The paper stated that a monofocal or non-diffractive IOL should be considered for patients with co-existing eye disease. There was a lack of agreement for issues related to IOL selection, with the paper stating that “experts only agreed on the importance of the patients’ habits.”

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Product news

• Optos expanded imaging modalities available with its California FA ultra-widefield retinal imaging device to include, in addition to its existing imaging modalities, an ultra-widefield red/green/blue image.
• Iridex announced its next-generation of the PASCAL Laser System, which a press release about the technology stated is the “first FDA-cleared ophthalmic laser system to offer pattern scanning capabilities, MicroPulse Technology, Endpoint Management Technology, and Pattern Scanning Laser Trabeculoplasty” in one device.

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