FDA approves Eylea 12-week dosing for wet AMD

The FDA has approved a supplemental biologics license application for a 12-week dosing schedule of Eylea injection in wet age-related macular degeneration patients, Regeneron announced in a press release.
The FDA previously issued a complete response letter to Regeneron regarding the sBLA, which is based on data from the phase 3 VIEW 1 and 2 trials, in which wet AMD patients received Eylea (aflibercept) injections at least every 12 weeks, with additional doses as needed.
“We are pleased that the FDA has approved an updated label for Eylea,” George D. (Read more...)

CMS 2019 proposal offers new coding options to GIs

AUSTIN, Texas — In this exclusive video perspective from GI Outlook 2018, Glenn Littenberg, MD, FASGE, chair of the ASGE reimbursement committee and chief medical officer at inSite Digestive Healthcare in California, discusses a new Centers for Medicare and Medicaid Services proposal that would change the way services are documented and paid for starting in 2019.
The revised plan would loosen paperwork requirements for reimbursement, giving physicians more time with their patients, Littenberg told Healio Gastroenterology and Liver Disease.
“Their idea was to try to reduce the burden

At Issue: Ensuring LASIK success and minimizing complications

Earlier this summer, LASIK was the topic of a New York Times article in which patients described negative side effects and complications after the procedure, including dry eye, aberrations, blurred vision and burning.
The American Academy of Ophthalmology responded to the article, saying that while complications are possible, the risks are low.
“The risks of LASIK surgery are known in the ophthalmology community and have been studied consistently since the FDA approved the procedure 20 years ago,” AAO President Keith Carter, MD, said in the statement. “More than 300