Miebo: how long were the pivotal tox studies?

“Ocular instillation of F6H8 at the dose of 427.8 mg/animal/day, four times daily bilaterally (~3 hours apart) for up to 26 weeks in NZW rabbit was well tolerated and did not induce any ocular or systemic signs of toxicity.”

“In a 26-week ocular toxicity study in rabbits, ocular instillation of perfluorohexyloctane ophthalmic solution, 100% (code name: F6H8) at the dose of 427.8 mg/day, four times daily bilaterally for up to 26 weeks was well tolerated and did not induce any ocular or systemic signs of toxicity.”

“Once daily oral administration of F6H8 at doses up to 2000 mg/kg/day to Wistar rats for 28 consecutive days were well tolerated and did not produce F6H8 related toxicity.”