Ocular Therapeutix, the latest endeavor of serial entrepreneur Amar Sawhney, released positive findings from a Phase II study of its absorbable intracanalicular plug, designed to provide long-term drug therapy following eye surgery.
Ocular Therapeutix enrolled 60 cataract surgery patients in a placebo-controlled, randomized clinical trial designed to evaluate sustained-release dexamethasone in treatment of post-operative inflammation and pain.
With successful results from the Phase II study, Ocular Therapeutix hopes to move into Phase III next year, given FDA approval.
"To the best of our knowledge this is the 1st randomized, controlled, multi-center clinical study of a sustained release anti-inflammatory agent delivered via intracanalicular plugs, to demonstrate compelling efficacy, ever to be conducted by any company in the U.S.," Sawhney said in prepared remarks. "The plugs were highly retained and with less than a 10% drug load compared to drops, and performed excellently in safety as well as efficacy."
The plugs may also be able to provide tailored therapy that provides further enhances the safety and efficacy profile of post-surgery treatment, he added.
Patients given the placebo reported higher rates of pain at all time-points through 1 month of follow-up, according to a company statement, and the drug therapy caused no increases in intraocular pressure. The placebo group also had a much higher rate of anterior chamber cell counts, with only 3.4% of placebo patients reported with zero cell count, compared with 34.5% in the drug therapy group.
All drug therapy patients retained the plug through 2 weeks, and 96.6% of them through day 28 of the study. The implanted plugs could reduce the need for patients to use eye drops, which have lower rates of compliance and thus can leave patients with issues after surgery.
Ocular Therapeutix has been on a roll, recently landing a positive vote, with reservations, from the FDA’s Ophthalmic Devices Panel in favor of the company’s ReSeal ophthalmic incision sealant.