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FDA raises concerns about cross-linking system in complete response letter to Avedro

April 1, 2015

Avedro received a complete response letter from the FDA regarding the new drug application for its riboflavin ophthalmic solution/KXL system for corneal cross-linking, according to a press release.

In the letter, the FDA stated that it has identified a “small number of areas on the application” that require additional information concerning the device, but none of which pertains to the clinical study safety or efficacy data presented in the application, the release said.

In the Journals

Preaponeurotic fat advancement flap prevents unintended eyelid creases in levator recession

April 1, 2015
Use of a preaponeurotic fat advancement flap was found to be an effective method for preventing unintended multiple lid creases and providing satisfactory outcomes with…

Kala announces positive results in phase 2 dry eye trial

April 1, 2015
Kala Pharmaceuticals Inc. announced top-line results in a phase 2 clinical trial of KPI-121 in patients with dry eye disease, the company announced in a press…
FDA News

FDA clears five application upgrades for Lensar laser system

April 1, 2015
Lensar received 510(k) clearance from the FDA for five new application technologies for the Lensar laser system, according to a press release.The five upgrades…
BLOG: Planning your 10-year countdown to retirement, part 2 Blog

BLOG: Planning your 10-year countdown to retirement, part 2

April 1, 2015
In the last blog entry, I kicked off the concept of making a 10-year plan as a run-up to retirement by first of all forcing yourself to sit down and have the discipline…
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Practical Retina

Comparing Aflibercept, Bevacizumab, and Ranibizumab for DME: Analysis of DRCR Protocol T

Ophthalmic Surgery, Lasers and Imaging Retina
Online Advanced Release, March 5, 2015
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CME
Challenges and Solutions in Retinal Vascular Disease: Pigment Epithelial Detachment and Refractory Diabetic Macular Edema

Challenges and Solutions in Retinal Vascular Disease: Pigment Epithelial Detachment and Refractory Diabetic Macular Edema

This activity is supported by an educational grant from Regeneron Pharmaceuticals, Inc.

With anti-VEGF therapy well-established as front-line therapy in the management of age-related macular degeneration and…
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Meeting News Coverage Video
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VIDEO: The role of posterior corneal surface in astigmatism correction during cataract surgery

March 31, 2015
John A. Hovanesian, MD, FACS, discusses a variety of techniques available to correct astigmatism.
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