Visx' excimer laser gets approvable recommendation
This article was originally published in Clinica
Visx' (US) excimer laser system for photorefractive keratectomy received a conditional approval recommendation from the US FDA's ophthalmic devices advisory panel on October 20th. Panel members criticised the company for having incomplete patient follow-up and said they would not recommend approval until two-year follow-up included 90-95% of patients. Visx is seeking marketing approval for use of the laser in patients 18 years and older with -1.0 to -6.0 dioptre myopia with a best corrected vision of at least 20/40.
You may also be interested in...
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.