Home  >  News
International + Font Resize -

Icon Bioscience receives FDA approval for dexycu, a potentially transformational drug therapy for treating inflammation associated with cataract surgery

Newark, California
Wednesday, February 14, 2018, 16:00 Hrs  [IST]

Icon Bioscience, a specialty biopharmaceutical company focused on utilizing its Verisome drug-delivery platform to develop unique intraocular eye-care therapeutics, announced that the United States Food and Drug Administration (FDA) has approved IBI’s New Drug Application (NDA) for DEXYCU (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery.

“DEXYCU breaks new ground in the treatment of inflammation in post cataract surgery because it is applied as a single injection administered at the conclusion of surgery.”

IBI noted that in the US alone, over four million cataract surgeries are performed annually and that current standard of care for inflammation associated with the surgery involves a relatively arduous process by which patients, in a largely elderly population, assume the post-surgical responsibility of self-administering medicated eye drops, several times daily over a period of weeks.

David S. Tierney MD, IBI’s president & chief executive officer, said, “DEXYCU breaks new ground in the treatment of inflammation in post cataract surgery because it is applied as a single injection administered at the conclusion of surgery.” DEXYCU employs IBI’s Verisome technology to dispense a biodegradable extended-release formulation of dexamethasone into the posterior chamber of the eye.

Commenting on today’s announcement, Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology, New York University, and Trustee, Dartmouth Medical School, and lead investigator for DEXYCU clinical studies, said, “The approval of DEXYCU represents a significant advancement in ophthalmic drug development as DEXYCU is the first long-acting intracameral product approved by the FDA for treating inflammation following cataract surgery.”

Dr. Donnenfeld continued by saying, “DEXYCU is designed to improve the management of inflammation post cataract surgery. This novel ophthalmic medication offers the cataract surgeon the option of a single administration of a corticosteroid at the site of action. This, in turn, benefits patients by eliminating non-compliance and dosing errors associated with the current practice of relying on the patient dispensing frequent drops following cataract surgery.”

Dr. Tierney said, “FDA approval of DEXYCU marks a key milestone in Icon’s commitment to deliver innovative advances in ophthalmic specialty pharmaceuticals by providing treatment options that challenge and surpass the traditional pharma approach to eye care.” He concluded saying, “As Icon steps across the threshold from R&D to an approved product, we look forward to announcing our plans to bring DEXYCU into the marketplace.”

 

*POST YOUR COMMENT
Comments
* Name :     
* Email :    
  Website :  
   
     
 
ipc_2018
cphi-india_Banner-150x60
 
 
 
 
Copyright © 2016 Saffron Media Pvt. Ltd |