Ocular Therapeutix receives FDA agreement under SPA for trial of AXPAXLI

Ocular Therapeutix (OCUL) announced it has received written agreement regarding a registrational trial design from the U.S. Food and Drug Administration, FDA, under a Special Protocol Assessment, SPA, for the Company’s planned clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy, NPDR. “Securing a Special Protocol Assessment agreement from the FDA for our planned NPDR trial represents a major milestone as we look to broaden the impact of AXPAXLI beyond wet AMD and into diabetic eye disease. This formal agreement ensures direct FDA alignment with our proposed approach for NPDR and provides us with a clear regulatory path forward. We are confident AXPAXLI will be successful in the trial design and primary endpoint agreed upon with the FDA,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “The opportunity in diabetic eye disease is tremendous, with diabetic retinopathy affecting nearly 9 million people in the U.S. alone. We believe AXPAXLI, with its potential for annual dosing, could offer a transformative approach to improving outcomes while preventing or substantially reducing the rate of vision-threatening complications in these patients. We look forward to providing more details about our strategy in NPDR and DME at our upcoming Investor Day on September 30th.”