Industry News

Heru Expands Wearable Platform

Heru announced the launch of a new screening tool for dark adaptation in AMD patients. The wearable device provides a non-invasive, dark adaptation exam in as little as 4.5 minutes for a rapid exam, or 20 minutes for an extended exam. The dark adaptation function supplements an existing contrast sensitivity exam that uses the same headset. The company hopes the device will lead to earlier detection of AMD, as well as longer term monitoring of existing disease. www.seeheru.com

CyclASol dry eye drug approval

Heidelberg-based Novaliq announced the US FDA New Drug Application (NDA) approval of CyclASol® (cyclosporine ophthalmic solution) for treating the signs and symptoms of dry eye disease.

“If approved, CyclASol would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease. It shows impressive and rapid therapeutic effects objectively measured on the ocular surface in the majority of patients, with clinical benefits on the signs and symptoms of the disease,” said Christian Roesky PhD, CEO, Novaliq.

CyclASol employs Novaliq’s EyeSol® proprietary water-free technology, using ultrapure semifluorinated alkanes (SFAs) physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. www.novaliq.com

AMD IMPLANT RECALL

The Susvimo (ranibizumab injection) ocular implant has been recalled by Genentech/ Roche to evaluate a manufacturing issue. The device received US FDA approval last year for wet AMD treatment. The recall has led to a pause in implantations and clinical trials involving the device.

“We noticed in our laboratory testing— reliability testing—that in certain cases, the septum, which is the seal on the port delivery device that prevents the medicine from leaking out once it has been injected in, could fail after repeated dosing. … Because it didn’t meet our performance standards and we want to make sure we have high reliability, we decided to voluntarily stop distribution of the Port Delivery System,” said Bill Anderson, CEO, Roche Pharmaceuticals in a call with investors.

Approved in October 2021, the refillable Susvimo allowed patients to receive as few as two treatments per year. The company emphasised the recall does not involve the ranibizumab vial or refill needle, and treatment with refills can continue. www.gene.com