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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.

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…
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VIDEO: Speaker presents results from the Age-Related Eye Disease Study 2

April 1, 2015
At Hawaiian Eye 2015, Emily Y. Chew, MD, discusses the Age-Related Eye Disease Study 2 data and how the results should change the ophthalmic practice.
Business News

NovaBay reports lower net loss in 2014

March 31, 2015
NovaBay Pharmaceuticals reported a 2014 net loss of $15.2 million, or $0.31 per share, compared with $16 million, or $0.42 per share, in 2013, according to a press…
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Postoperative Inflammation and Pain

Postoperative Inflammation and Pain: Elimination of the Dynamic Duo to Improve Patient Outcomes

This activity is supported by an educational grant from Bausch + Lomb.

Cataract surgery has improved in both safety and outcomes in recent years. With advances in surgical techniques…
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VIDEO: Electrodiagnostic testing contributes to glaucoma diagnosis

March 23, 2015
NEW YORK – Electrodiagnostic testing provides another modality to add to the diagnostic armamentarium for glaucoma…
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