Allogenic cell therapy receives regulatory approval for bullous keratopathy indication

Aurion Biotech received approval from Japan’s Pharmaceuticals and Medical Devices Agency for Vyznova for bullous keratopathy. According to the company’s press release, this is thought to be the first regulatory approval worldwide for an allogenic cell therapy to treat corneal endothelial disease.

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24-month data on AMD photobiomodulation therapy

LumiThera announced 24-month data from its prospective, double-masked, randomized, multicenter clinical trial that enrolled 100 patients with early to intermediate dry AMD. Patients were treated either with the company’s Valeda Light Delivery System every 4 months or sham, with the last treatment administered at 21 months and last follow-up at 24 months. The analysis included 91 eyes treated with the photobiomodulation therapy and 54 eyes treated with sham. The company’s press release reported that the trial showed sustained, statistically significant BCVA at 13 months in the photobiomodulation treatment group compared to sham, and improvement from baseline in BCVA at 24 months remained statistically significant (5.9 vs. 1.0 letters). Additionally, the company noted that 58% of the eyes in the treatment group had a 5 or greater letter gain.

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Patient enrollment complete for Phase 3 trial evaluating topical presbyopia treatment

Visus Therapeutics completed patient enrollment and last visit for its Phase 3 pivotal trial evaluating BRIMOCHOL PF as a preservative-free topical ophthalmic solution for presbyopia. BRIMOCHOL PF combines carbachol and brimonidine tartrate to create a sustained pinhole effect to improve near vision. Results from the trial are expected to be presented in the second quarter of 2023.

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Pre-IND meeting for treatment of corneal endothelial disease

Kuria Therapeutics completed a pre-Investigational New Drug (IND) meeting with the FDA for KTX-1161 for treatment of corneal endothelial disease. KTX-1161 is a topical ophthalmic solution based on an Nrf2 activator. According to the company’s press release, this therapy could be used for patients with Fuchs dystrophy or patients having cataract surgery.

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IND submitted for geographic atrophy treatment

Aviceda Therapeutics submitted an IND to the FDA for its intravitreal glycan-coated nanoparticle being investigated to treat geographic atrophy secondary to AMD. According to the company’s press release, AVD-104 is an immunomodulator designed to inhibit inflammatory and complement pathways associated with geographic atrophy. The compound was well-tolerated during dose-range finding studies in non-human primates and rabbits.

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Second Phase 3 trial for dry eye disease therapy

Bausch + Lomb and Novaliq announced publication of the second pivotal trial for NOV03 (perfluorohexyloctane) for treatment of signs and symptoms of dry eye disease associated with MGD. According to the company’s press release, there are currently no FDA-approved dry eye therapies that address evaporation directly. The company reported that the second pivotal trial data are consistent with the first trial, supporting the ability of NOV03 to relieve the signs and symptoms of dry eye associated with MGD. The FDA assigned June 28 as the PDUFA date for NOV03.

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ASCRS news and events

• ASCRS Annual Meeting: Register for the ASCRS Annual Meeting, May 5–8, in San Diego, California, before the Tier 2 registration deadline on April 2. Review the ASCRS ASOA Real-Time Program for the latest program details.
• Eyecelerator: Registration is open for Eyecelerator @ ASCRS 2023. The innovation conference from ASCRS and the American Academy of Ophthalmology will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology.

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Research highlights

• Several corneal biomechanical parameters were compared between normal thin corneas and those of keratoconic eyes. The cross-sectional comparative study published in the Journal of Cataract & Refractive Surgery evaluated dynamic corneal response parameters using the Corvis ST (Oculus) in 61 eyes with keratoconus and 61 eyes that were healthy but with corneas 500 microns or less at their thinnest point. According to the paper, all biomechanical parameters were statistically significant between the two groups (except first and second applanation length, first and second applanation velocity, and deformation amplitude in the highest concavity phase). The largest mean difference was seen in stiffness at first applanation. The authors concluded that the kerotoconic corneas were significantly softer compared to the healthy corneas that were matched for thickness.
• The indications for IOL exchange, outcomes, and complications were the topic of a paper published in Clinical Ophthalmology. The study included 511 eyes of 489 patients from May 1, 2014, through August 31, 2020. Visual acuity improved from 20/192 preop to 20/61 after IOL exchange, with most (78.7%) eyes coming within 1.0 D of desired outcome. According to the paper, the most frequent complication was CME. The authors reported that iris sutured IOLs were more likely to experience subsequent IOL dislocation compared to 4-point scleral sutured IOLs, anterior chamber IOLs, or 2-point scleral sutured IOLs. The Yamane scleral fixation technique saw IOL tilt in 11.8% of cases, compared to 0% for anterior chamber IOLs, 1.1% for 4-point scleral sutured, 0% for 2-point scleral sutured, and 0% for iris sutured.

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Product news

• Custom Surgical launched its next-generation MicroREC microscopes and slit lamps.

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