Phase III study results demonstrated that Anika Therapeutics’ CINGAL® hyaluronic acid (HA)/corticosteroid viscosupplement provided superior immediate and short term pain relief after injection vs. HA alone, and superior relief from OA-related pain, stiffness and function through 26 weeks vs. saline.
CINGAL remains under FDA regulatory review in the U.S. Anika is prepared to enroll patients in a supplemental Phase III study requested by FDA, and expects receipt of FDA clearance of the product thereafter.
As described in the company’s 1Q17 earnings call, the additional Phase III study:
is a randomized, double-blind, active comparator controlled, multi-center trial
will investigate CINGAL’s ability to provide relief of knee OA symptoms in patients who have not responded to conservative treatment
comprises three treatment arms, to include CINGAL, MONOVISC and a steroid
Phase III study results demonstrated that Anika Therapeutics' CINGAL® hyaluronic acid (HA)/corticosteroid viscosupplement provided superior immediate and short term pain relief after injection vs. HA alone, and superior relief from OA-related pain, stiffness and function through 26 weeks vs. saline.
CINGAL remains under FDA regulatory review...
Phase III study results demonstrated that Anika Therapeutics’ CINGAL® hyaluronic acid (HA)/corticosteroid viscosupplement provided superior immediate and short term pain relief after injection vs. HA alone, and superior relief from OA-related pain, stiffness and function through 26 weeks vs. saline.
CINGAL remains under FDA regulatory review in the U.S. Anika is prepared to enroll patients in a supplemental Phase III study requested by FDA, and expects receipt of FDA clearance of the product thereafter.
As described in the company’s 1Q17 earnings call, the additional Phase III study:
is a randomized, double-blind, active comparator controlled, multi-center trial
will investigate CINGAL’s ability to provide relief of knee OA symptoms in patients who have not responded to conservative treatment
comprises three treatment arms, to include CINGAL, MONOVISC and a steroid
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