FDA Approves Olopatadine Hydrochloride for Ocular Itching


FDA Approves Olopatadine for Ocular ItchingOn February 3, 2015 the FDA approved Olopatadine Hydrochloride, ophthalmic solution 0.7%, for the treatment of ocular itching due to allergic conjunctivitis. Known as the brand name Pazeo, which is marketed by Alcon, the approved dose is one drop in each affected eye daily. Positive data from two trials coined Conjunctival Allergen Challenge demonstrated that significant relief from ocular itching was found after just 24 hours. When compared to the Olopatadine drop 0.2%, or the brand name Pataday, the 0.7% drop proved efficacy after a shorter time period. Adverse effects were extremely uncommon, with a minor number of patients reporting dry eye or slight blurriness. The option for effective and swift relief for patients suffering from severe itching due to allergic conjunctivitis is encouraging news for this sizable patient population. Pazeo solution will become available by prescription starting in March 2015.

Allergies are prevalent in the United States, with approximately one third of people affected by seasonal allergy symptoms. A staggering 75 percent of these allergy sufferers endure minor to intense ocular itching as a result of allergic conjunctivitis. Olopatadine has proven safe for patients who wear contact lenses, although it is advised that at least five minutes pass after administration of the drop before lenses are placed in the eyes. Symptoms of allergic conjunctivitis include:

  • Extreme itching and/or burning eyes
  • Red eyes
  • Puffy eyelids, particularly in the morning
  • Excessive tearing
  • Dilated blood vessels in the clear tissue that covers the whites of the eyes

LGM Pharma can assist clients as a supplier/distributor of the API Olopatadine Hydrochloride, CAS# 140462-76-6 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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