The FDA has granted Breakthrough Therapy Designation for Tinlarebant based on positive interim results from the global phase 3 DRAGON trial. The designation aims to accelerate the development and review process for drugs targeting serious or life-threatening conditions by requiring substantial improvement over existing therapies on clinically significant endpoints. This regulatory status underscores the potential of Tinlarebant to address unmet medical needs and signifies a significant milestone in its path to market approval.
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