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Ophthalmology Management

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Quick Notes: June 23, 2023

FDA clears Eyenuk to use Topcon NW400 retinal camera with EyeArt AI system to detect DR; FDA denies Aldeyra's NDA for ADX-2191 for PVRL; and more.

Ophthalmology Management June 23, 2023

  • Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy, adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. The regulatory clearance of the EyeArt v2.2.0 system makes it the first AI system that is FDA-cleared for use with multiple retinal cameras by different manufacturers. In addition, the company's FDA clearance also includes Eyenuk's proprietary real-time image quality feedback solution and an upgraded image quality assessment module, to achieve best-in-class gradability (ie, percentage of patients with conclusive reports) without the need for eye dilation.

  • Aldeyra Therapeutics announced receipt of a Complete Response Letter from the FDA for the 505(b)(2) new drug application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL). Although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a “lack of substantial evidence of effectiveness” due to “a lack of adequate and well-controlled investigations” in the literature-based NDA submission. Based on prior discussions with the FDA, Aldeyra did not conduct any clinical trials of ADX-2191 in PVRL. Aldeyra plans to discuss ADX-2191 for the treatment of PVRL with the FDA, including the potential to make it accessible to PVRL patients under an Expanded Access Program protocol.

  • Sight Sciences announced that Cigna Healthcare updated its Glaucoma Surgical Procedure policy to cover both ab interno canaloplasty and goniotomy (trabeculotomy) procedures for the treatment of open-angle glaucoma effective June 15, 2023. Cigna’s coverage policy includes procedures enabled with the OMNI Surgical System technology as medically necessary and covered. This includes the OMNI outflow restorative procedure that addresses all three points of aqueous resistance associated with glaucoma (Schlemm’s canal, collector channels and trabecular meshwork) when deemed medically necessary by the patient’s ophthalmologist. Cigna’s updated Glaucoma Surgical Procedures policy can be found here. 

  • A new study published in JAMA Ophthalmology, “Prevalence of Diabetic Retinopathy in the US in 2021,” found that in 2021, an estimated 9.6 million people in the United States (26.4% of those with diabetes) had diabetic retinopathy (DR), and 1.84 million people (5.1% of those with diabetes) had vision-threatening diabetic retinopathy (VTDR). The number of people aged 40 years and older living with diabetes-related eye disease more than doubled since prevalence was last estimated in 2004. VTDR has also almost doubled since last estimated in 2004. The study is the first of its kind to estimate the prevalence of DR and VTDR in people younger than 40 years. In the youngest age group, ages 0 to 24 years, more than one in 10 people with diabetes had DR, which increased to nearly one in five among people with diabetes ages 25 to 39 years. For more, see the study results here.

 

  • Horizon Therapeutics announced the publication in the Multiple Sclerosis Journal of a new analysis from the N-MOmentum clinical trial of UPLIZNA demonstrating the utility of an adjudication process that could improve clinical care decision-making in neuromyelitis optica spectrum disorder through more accurate and consistent assessment of disease-related attacks. Of the 230 participants in the trial, 64 participant-reported neurological events occurred; 51 of these (80%) were deemed attacks by the trial investigators, and 43 of those (84%) were independently confirmed by the adjudication committee (AC). MRI and serum glial fibrillary acidic protein biomarker findings provided additional specificity in the attack adjudication process. New domain-specific lesions were found in 90% of adjudicated attacks for which MRI data were available, and use of MRI allowed for confirmation of 33% of adjudicated attacks for which clinical findings were inconclusive. For more, see the analysis here.

 

  • Eyebiotech Limited (EyeBio) announced the dosing of the first participants in its Phase 1b/2 AMARONE (Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation) clinical trial in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). The trial will evaluate the safety and preliminary efficacy of intravitreal Restoret (EYE103), an investigational, tri-specific antibody that acts as an agonist of the Wnt signaling pathway that is designed to resolve residual fluid in the retina and to improve visual acuity in individuals with NVAMD and DME, as well as other retinal diseases of permeability. The primary endpoints of the trial are safety and mean change in BCVA from baseline to Week 12 in the study eye of the participants, using the standardized ETDRS. The AMARONE trial is the first clinical trial from EyeBio’s pipeline of multi-specific antibodies.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.