Regulatory/Legislative News

The U.S. Patent and Trademark Office has granted Can-Fite BioPharma U.S. patent No. 8,557,790 for an A3 adenosine receptor agonist to reduce IOP, according to a press release.

Avedro has received CE mark clearance for the KXL II advanced cross-linking system, according to a press release.

A long economic crisis and a government that is slow to foster and finance innovation are threatening the exemplary but delicate balance of ophthalmology in Iceland, according to ophthalmologists interviewed by OCULAR SURGERY NEWS.

Some panel members abstained from voting or voted that ReSure Sealant had not been demonstrated to be safe and effective when used for the proposed indications for use, according to member Bennie H. Jeng, MD, MS.

GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the U.S. Food and Drug Administration affirmed the safety and benefit-risk profile of ReSure Sealant in a September vote.

Of the drugs approved by the FDA in 2008, those that received expedited reviews were approved more quickly, were studied in fewer patients and still have unanswered safety questions, according to new data published in JAMA Internal Medicine.

The final ruling recommended reimbursing Jetrea (ocriplasmin, ThromboGenics/Alcon) for patients with vitreomacular traction and full-thickness macular holes up to 400 µm in diameter in the absence of epiretinal membrane.

The U.S. Food and Drug Administration has cleared the Femto LDV Z6 femtosecond laser for the use of clear corneal and arcuate incisions during cataract surgery, according to a news release from Ziemer Ophthalmic Systems.

Citing concerns about safety and manufacturing standards, the U.S. Food and Drug Administration has notified Alimera Sciences that it cannot approve the company’s new drug application for the Iluvien intravitreal implant.

On October 12, California Gov. Jerry Brown vetoed California Senate Bill 598, which had passed the State Assembly and State Senate with strong bipartisan support. If enacted, Senate Bill 598 would have allowed biosimilars approved by the FDA as interchangeable substitutes for their biological reference products, but would have required a pharmacy to notify a prescriber of the substitution.