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Clanotech Drug Gets FDA Orphan Label

Clanotech AB’s candidate drug CLT-28643 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for prevention of scarring after glaucoma surgery. The European Medicines Agency (EMA) previously granted an orphan drug designation pertaining to the EU. The orphan drug designation is expected to significantly shorten future market approval processes and reinforce market exclusivity for a product released in the U.S. and EU.

“This positive decision from the FDA underpins the great need for products that can improve the outcome of glaucoma surgery. Clanotech is now preparing for a phase I/II trial with CLT-28643,” says Patrizia Caldirola, CEO, Clanotech. The company’s lead compound, an a5ß1-integrin antagonist, has anti-angiogenic, anti-fibrotic and anti-inflammatory properties. Based on promising preclinical data in animal models for glaucoma, CLT-28643 has the potential to enhance the wound healing processes following glaucoma surgery.

Glaucoma patients who do not respond to medications that lower the eye’s intraocular pressure undergo a surgical procedure to create a flap in the eye to drain liquid and more effectively lower the pressure in the eye. Correct healing of the flap is critical for the long term success of the procedure. A cytotoxic antimetabolite is used today to prevent closure of the flap; however, the treatment is associated with significant side effects. Clanotech’s mission is to improve the outcome of glaucoma surgery by developing CLT-28643 to replace non-specific cytotoxic treatment with a target specific therapy with an improved safety profile.

Source: Clanotech