FDA Approves Ketorolac and Phenylephrine for Eye Surgery


FDA Approves Ketorolac and Phenylephrine for Eye SurgeryApproximately four million Americans undergo cataract surgery every year, so the recent FDA approval of Ketorolac and Phenylephrine on June 2, 2014 is timely and beneficial for many patients in the United States. Known as the brand name Omidria, the combination of Ketorolac and Phenylephrine to create an efficacious pupil-dilating agent has been deemed successful and safe in a variety of studies. This unique drug assists in maintaining pupil size and keeping intraoperative miosis from occurring during cataract surgery. The Ketorolac and Phenylephrine combo also acts as an anti-inflammatory agent which helps to reduce pain and swelling post-surgery. Omidria {Ketorolac and Phenylephrine} is now FDA approved to be used alongside best in care irrigation solution throughout cataract surgery as well as during other surgical procedures that entail an intraocular lens replacement with an artificial lens.

Cataract surgery is extremely common both in the United States and worldwide, and the advances of medical technology as well as tolerable and effectual drug treatments like Ketorolac and Phenylephrine have made these procedures common and largely uncomplicated. As the first FDA approval for Omeros in two decades, Omidria is poised to be a reliable and effective treatment for patients undergoing cataract surgery. The unpredictability of miosis and pain post-cataract surgery has been challenging for surgeons and patients, however, the advent of Ketorolac and Phenylephrine offers improved surgical outcomes for the patients and a greater opportunity for success for physicians and surgical staff.

Ketorolac, half of the dynamic duo alongside Phenylephrine making up Omidria acts as a powerful anti-inflammatory component. This anti-inflammatory action has proven in studies to greatly reduce the need for preoperative nonsteroidal anti-inflammatory drugs, which often cause adverse gastrointestinal side effects in patients. Phenylephrine does possess a risk of higher than normal blood pressure, and this combination treatment is not advised for use in people with uncontrolled high blood pressure or for children. Common side effects from Omidria included anterior chamber inflammation of the eye and posterior area irritation of the eye. Ketorolac and Phenylephrine must be diluted before use before and during the surgical procedures.

LGM Pharma is a provider of the APIs Ketorolac, CAS # 74103-06-3 and Phenylephrine, CAS # 59-42-7 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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