FDA approves AI-based diabetic retinopathy screener

AEYE Health announced that it received FDA approval for its AI-based system for screening for diabetic retinopathy. According to the company’s press release, this approval is based on Phase 3 results that showed 93% sensitivity and 91.4% specificity of the system, which uses a single image per eye. The company stated that the system is able to deliver a diagnostic result for more than 99% of patients and dilation is rarely required. Going forward, AEYE Health is pursuing clinical trials to develop a screening for glaucomatous optic neuropathy.

Back to top

FDA accepts NDA for Demodex treatment

Tarsus Pharmaceuticals announced that its NDA for TP-03, a treatment for Demodex blepharitis, was accepted by the FDA. The FDA set the PDUFA target action date for August 25, 2023. Separately, the company is continuing its investigation (currently a Phase 2 clinical trial) for TP-03 for meibomian gland disease.

Back to top

Phase 2b results for MGD therapy

Azura Ophthalmics announced positive results from its Phase 2b clinical trial of AZR-MD-001 0.5% for treatment of meibomian gland dysfunction. According to the company’s press release, the drug resulted in an improvement in meibomian gland liquid secretions (the number of open glands) and improved symptoms, as measured by OSDI. The company also stated that meibum quality, tear break-up time, and SPEED scores were improved. More specifically, the therapy at 3 months resulted in a mean of 1.8 more open glands secreting meibum from baseline. OSDI scores improved a mean 3.5 points from baseline at 3 months. The company reported the therapy was well tolerated with most adverse events being mild and transient.

Back to top

Phase 1/2 trial evaluates investigational TED treatment

Viridian Therapeutics announced positive data from its Phase 1/2 proof-of-concept trial of VRDN-001, an anti-IGF-1R antibody delivered via infusion. According to the company’s press release, signs and symptoms of thyroid eye disease (TED) improved after two infusions of 20 mg/kg VRDN-001. The study was double blind and placebo controlled. The two infusions were given 3 weeks apart with efficacy measured 6 weeks after the first dose. Two cohorts, each with six patients who received VRDN-001 and two who received placebo, have been studied thus far (one with 10 mg/kg and one with 20 mg/kg); a third cohort will be dosed in early January. The two cohorts thus far have demonstrated a 75% proptosis responder rate (≥2 mm reduction in proptosis from baseline), with a mean 2.04 mm reduction in proptosis.

Back to top

Phase 1 clinical trial to study synthetic cannabinoid derivative for glaucoma

Skye Bioscience announced that it has begun screening patients for its first-in-human Phase 1 clinical trial of SBI-100 ophthalmic emulsion, which the company described as a synthetic cannabinoid derivative, to treat glaucoma. The study, taking place in Australia, is randomized, double masked, placebo controlled, and will assess the safety and tolerability in healthy volunteers first. According to the company, SBI-100 is based on previous research that showed IOP lowering with use of cannabinoids. SBI-100 is designed to penetrate ocular tissue adequately while avoiding psychotropic effects of systemic cannabinoid use. The company stated that the product demonstrated an IOP-lowering effect in preclinical studies involving three animal species.

Back to top

OCT company rebrands

SVision Imaging, an OCT imaging company, announced that it is rebranding under the name Intalight. The company also announced that it is submitting a 510(k) for its DREAM OCT device, which it described as swept-source OCT with 12-mm depth scanning. A longer wavelength, according to the company, allows the technology to penetrate through lens or vitreous opacities.

Back to top

ASCRS news and events

• 2023 ASCRS Educator Award: ASCRS is accepting nominations for its Educator Award, which will be given at the 2023 ASCRS Annual Meeting. Submit a nomination by November 22.
• 2023 ASCRS Annual Meeting: Early bird registration opens Monday, November 21. Find more info here.
• ASCRS Grand Rounds: The latest episode of ASCRS Grand Rounds presented by Emory Eye Center is online and on demand.

Back to top

Research highlights

• Two cases of hemorrhagic occlusive retinal vasculitis (HORV) after transzonular delivery of triamcinolone-moxifloxacin at the conclusion of cataract surgery were reported in JAMA Ophthalmology. The authors described the cases as “similar to vancomycin-associated HORV findings” and advocate for thorough postop evaluations of first eyes that receive intravitreal triamcinolone-moxifloxacin in order to “recognize this disorder and prevent consequences of surgery in the second eye.” The authors stated that a study limitation is “the possibility of medication mix-up by the patients’ pharmacies.”
• A retrospective, consecutive case series published in the Journal of Cataract & Refractive Surgery looked at the performance of a new IOL power calculation formula, the O formula. This formula, according to the paper, is based on ray tracing “without commonly used parameters, including ultrasound-compatible axial length, keratometry readings, and A-constant.” The study included 423 eyes that received a single-piece, L-loop, acrylic IOL. Biometric data were obtained with SS-OCT and an SS-OCT biometer. The O formula was compared to the Barrett Universal II and Kane at 1 month postop. The standard deviation of prediction error was significantly lower with the O formula than the Barrett but not statistically different from the Kane formula. The O formula, Barrett, and Kane put patients within 0.5 D of refractive prediction errors 75.4%, 77.1%, and 76.6% of the time, respectively. They were within 1 D 98.6%, 97.9%, and 98.1%, respectively. The authors concluded that the O formula is promising but it needs larger scale studies.

Back to top

Product news

• NIDEK launched the NT-1p Non Contact Tono/Pachymeter, which fully automates non-contact tonometry and pachymetry.

Back to top

---