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FDA Tells RegeneRx It Needs 3rd Phase III Trial On RGN-259 For Dry Eye Syndrome

 
• By Sten Stovall

The FDA is requiring an additional RGN-259 Phase III trial to further show efficacy in both signs and symptoms of dry eye in a larger patient population.

Eye
ReGenTree will begin the third Phase III trial, ARISE-3, this year. • Source: Shutterstock

Although the FDA has accepted all safety data from two Phase III trials of dry eye treatment candidate RGN-259, the agency wants the drug's backers to conduct an additional Phase III trial to further demonstrate its efficacy, a requirement that will push back its prospects for approval in treating a condition with high unmet medical need that affects more than 344 million patients globally.

The RGN-259 setback was announced on April 9 by RegeneRx Biopharmaceuticals Inc. and South Korea's GtreeBNT Co., Ltd, who...

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