FDA Panel to Consider Corneal Collagen Cross-linking

Tuesday, February 24, 2015 By Richard Smith           As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could […]

Device Maker Slammed by Injured Patients at FDA Meeting

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 2/24/2015 Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders […]

Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

By Jim Dickinson 02/18/2015 Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 […]

LASIK Activists Petition for Black Box Warning

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 01/05/2015 Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a “high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes” and asks […]

FDA Dims LASIK Harms it Found in ‘Life Quality’ Study

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. October 20, 2014 In a long-awaited report on a collaborative study it conducted on the post-surgical quality of life of LASIK patients, FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industry-favored term “visual symptoms” vs. the agency’s former […]

LASIK Study Shows Significant Number of Problems

October 19, 2014 Preliminary results from FDA study of LASIK show significant number of patients experience problems. Presenting preliminary results of the long-awaited LASIK Quality of Life Study during a keynote lecture at a meeting of the American Academy of Ophthalmology in Chicago on 10/17/2014, ophthalmologist Malvina B. Eydelman, MD, director of the FDA’s Division […]

Give FDA Authority over All Medical Device Ads?

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 8/2/2014 Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise “restricted” by FDA. Restriction most commonly occurs in the conditions of approval stipulated in writing by FDA at the time […]

Patient Advocate Slams FDA Denial of LASIK Petition

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 07/07/2014 LASIK patient advocate and former FDA LASIK advisory panel patient representative Paula Cofer has sharply criticized an eight-page FDA letter that denied a citizen petition submitted by former CDER branch chief Morris Waxler seeking the market withdrawal of approved LASIK excimer lasers and a public […]

How FDA Dropped Patient Warning Rule from LASIK Approvals

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 11/5/2013 FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement two years before public complaints about eye injuries from the procedure erupted. Two years before rising complaints erupted in public from LASIK patients with post-surgical vision problems, […]

LASIK is safer than contact lenses MYTH

October 8, 2013 “LASIK is safer than contact lenses” is a myth that began with a letter from three biased LASIK surgeons, Mathers et al, to the editor of the journal Archives of Ophthalmology in 20061. In the letter, Mathers and colleagues draw some bizarre conclusions about the safety of contact lenses vs. the safety […]