Eye Care

A Blog about Eye Care, Life and Everything!

Subscribe to feed Viewing entries tagged FDA

FDA Warns LASIK providers: Stop making false claims

Posted by Charl Laas
Charl Laas
Back at work and knee deep into contact lenses. Life is good.
User is currently offline
on Friday, 11 November 2011
in Eye Care ·

In recent months LASIK refractive surgery providers in the United States came under fire from the US Food and Drug Administration. The concern is not related to the safety aspect of LASIK but rather to the incorrect perception LASIK advertising is creating in the US and internationally. If one takes into account the new Consumer Protection Act, South Africa adopted this year it is also very relevant to the South Africanmedical refractive surgery fraternity.

Recently, Denise Mann wrote the following article for Health Day highlighting the matter:

Agency giving practitioners 90 days to curtail inflated promises, missing safety info in ads

The U.S. Food and Drug Administration is once again cracking down on eye care professionals who make false safety claims and promises about the popular LASIK eye surgery.

The agency's Letter to Eye Care Professionals, issued this week, follows an earlier warning from May of 2009. In its latest salvo against deceptive, potentially harmful advertising, the FDA is now giving eye doctors 90 days to get in line and update any advertising or promotional materials that make false claims. After this time, the agency will take regulatory action, said FDA spokeswoman Erica Jefferson.

"It's about the false claims and not adequately providing consumers with information about the risks associated with the procedure," she said.

...
Ophthalmic surgeon performing LASIK refractive surgery
Tags: FDA, LASIK
Hits: 505
Rate this blog entry

Allergan Receives FDA Approval for Zymaxid Ophthalmic Solution

Posted by Charl Laas
Charl Laas
Back at work and knee deep into contact lenses. Life is good.
User is currently offline
on Sunday, 23 May 2010
in Eye Care ·
Allergan, Inc. announced that the United States Food and Drug Administration (FDA) has approved Zymaxid (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia. Zymaxid is now the highest concentration gatifloxacin ophthalmic solution on the market in the United States.
 
As reported by the company, the efficacy of Zymaxid ophthalmic solution was assessed in two multicenter, double-masked, randomized dual-arm comparison studies involving 1,437 patients receiving either Zymaxid or vehicle. In the clinical studies, the efficacy of Zymaxid was defined as complete clearance of conjunctival hyperaemia and conjunctival discharge, and when all bacterial species present at baseline were eradicated. Results of these studies demonstrated that at Day six, complete clearance of conjunctival hyperaemia and conjunctival discharge was achieved in 58 percent of patients (193/333) treated with Zymaxid ophthalmic solution compared to 45 percent (148/325) in the vehicle group.
 
Zymaxid is expected to be available in the United States in June 2010.
Hits: 442
Rate this blog entry
0 votes

Activity Stream

 

Latest Forum Posts

More Topics »