Product Description.:
Drops , clear , clear
Colorless to pale yellow
BEPREVE is indicated for the treatment of itching associated with allergic conjunctivitis. Allergic conjunctivitis is characterized by intense ocular itching, redness, and tearing ? is the most common form of ocular allergy, affecting 20% -30% of the U.S. population or 60-90 million individuals. As a result of many technological and environmental factors, the incidence of allergic conjunctivitis is believed to be increasing in industrialized countries. Allergic conjunctivitis has a significant impact on the quality of life of allergy sufferers and remains a clinical challenge for physicians.
About BEPREVE
BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a non-sedating, anti-allergy eye drop that works on multiple components of the complex physiological process that produces allergy symptoms in the eye. BEPREVE is a selective blocker of histamine (H1), a principle mediator of allergy1,11. BEPREVE also stabilizes mast cells to prevent the release of additional pro-allergic factors .
BEPREVE has been clinically proven to produce rapid and sustained relief of ocular itching. In two well-controlled efficacy studies, BEPREVE consistently demonstrated both statistically and clinically superior reductions in ocular itching compared to placebo. These effects were observed within 3-7 minutes of a single drop and lasted for at least 8 hours6,7. A consolidated analysis of both studies showed that BEPREVE reduced ocular itching by 82% from baseline within 3 minutes6. This relief was clinically significant ? producing at least a 1 unit improvement in the patient?s ocular symptom score ? in 95% of patients at this time point7. At 8 hours following a single dose, 90% of patients still reported clinically significant relief of ocular itching7. Sixty-eight percent of patients who had severe itching achieved complete relief within 3 minutes.
BEPREVE has demonstrated safety and comfort comparable to placebo and is indicated in patients as young as two years old8,11. This favorable safety profile was observed in both the efficacy studies and in a separate, 6-week, randomized, placebo-controlled safety study of BEPREVE that enrolled 861 patients8. Furthermore, the active ingredient in BEPREVE, bepotastine besilate, has an extensive track record of systemic safety based on experience with more than 850 million doses given in Japan, where it is available in oral tablet form (Talion?) for allergic rhinitis, urticaria and pruritus associated with allergic skin diseases such as eczema9.
Warnings, Precautions, Adverse Reactions
BEPREVE is for topical ophthalmic use only. To minimize risk of contamination, do not touch the dropper tip to any surface. Keep the bottle closed when not in use. BEPREVE should not be used to treat contact lens?related irritation. Remove contact lenses prior to instillation of BEPREVE. The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%-5% of patients were eye irritation, headache, and nasopharyngitis.
