• Genentech announced it is voluntarily recalling the Susvimo (ranibizumab injection) ocular implant and insertion tool for the treatment of people with wet AMD in the United States. In addition, new implantations, including in ongoing global clinical trials, have been paused. The voluntary recall is based on recent testing of Genentech’s commercial supply in which Susvimo implants were exposed to repeated puncturing with a needle. The results showed that some implants did not perform to the company’s standards. For patients already implanted with Susvimo, there is no medical need to remove it. This is not a recall of the ranibizumab refill vial or refill needle, the company says, and eligible patients can continue receiving treatment via refills. Genentech notified the FDA and are working with the agency on the recall process, and has also taken immediate steps to inform other health authorities, health-care professionals, clinical trial investigators and patient organizations.

• Genentech also announced positive topline results from two global Phase 3 studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab-svoa), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). Both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every 4 weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every 4 weeks. Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness. Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.

• Novaliq announced the FDA accepted the new drug application for CyclASol (cyclosporine ophthalmic solution), an anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease. The Agency completed the filing review of the CyclASol NDA and determined that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023. CyclASol demonstrated in two pivotal studies fast onset of therapeutic effect in afflicted patients in this indication, clinical meaningful improvement of ocular surface damage and excellent tolerability.  

• DORC International announced the acquisition of Peregrine Surgical and the acquisition of the full ownership of WEFIS GmbH following an initial equity investment announced earlier in 2022. Both acquisitions significantly extend the production and innovation capabilities of the business while expanding the geographic reach and speed-to-market of DORC’s strategy.

• Notal Vision announced the publication of the second report of the Analysis of Long-term visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT) study results in Ophthalmology Retina that shows the importance of predictive analytics and home monitoring in ophthalmology. The 10-year retrospective study details the importance of digital remote monitoring for AMD patients. The second report specifically focuses on early management and clinical research capabilities provided by home monitoring technologies. The data showed that these patients were twice as likely to convert to wet AMD over the following two years. For more, see the study results here.

• Horizon Therapeutics presented new data defining molecular patterns in thyroid eye disease and further implicating the role of insulin-like growth factor-1 (IGF-1) in patients with low clinical activity score (CAS). This analysis reveals that in patients with both high and low CAS, there is clear activation of IGF-1 and related pathways, as well as the extracellular matrix organization, a structural network that supports cellular processes. The study analyzed genome RNA sequencing and pathway analysis in orbital tissue from patients with a CAS of ≥ 3 and patients with a CAS ≤ 2, as well as five control subjects. Though high CAS patients are often distinguished by activation of immune system pathways, which remain largely unaffected in low CAS patients, IGF-1 and its related pathways were found to be upregulated in both stages of disease.

• According to Research and Markets, The global ophthalmic equipment market is projected to reach $80.9 billion by 2027 from $63.4 billion in 2022, at a CAGR of 5.0%. The growth of this market can largely be attributed to the increase in elderly population, rise in adoption of digital devices and increasing prevalence of vision disorders. The consumer segment holds the largest share in the ophthalmic equipment market, by end user — the large share of consumers can be attributed to factors such as the increasing prevalence of eye disorders among the geriatric population, increasing usage of digital gadgets and growing adoption of spectacles and contact lenses among consumers. For more information from the report, click here. 

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.