Eye drops are a pain. Depending on the type, they can sting the eyes or cause other side effects, and remembering to use them every day is a nuisance. Ocular Therapeutix is one of the companies trying to come up with an alternative—a sustained-release drug delivery device that’s implanted in the eye, and dissolves when it’s done. While there’s still more to prove before the technology can head to market, it took an important step in that direction today with some good news from a clinical trial.
Bedford, MA-based Ocular (NASDAQ: OCUL) reported positive results from the first of two Phase 3 trials testing the safety and effectiveness of OTX-DP, an implantable device that, in this study, delivered the steroid dexamethasone into the eye over about four weeks. Ocular said the drug hit its two primary goals in a study of 247 patients with pain and inflammation following cataract surgery: compared to a placebo, it reduced pain after eight days, and it reduced the number of inflammatory cells in the eye after 14 days. The results were statistically significant, meaning they weren’t likely to be due to chance.
Ocular didn’t say whether the drug hit on certain secondary efficacy measures, however—like measures of pain on other days patients were evaluated, or the presence of so-called “flares,” or proteins in eye fluid that build up due to inflammation.
Still, Ocular said if it sees similarly positive results in a second Phase 3 study, from which it expects ha have results at the end of March, it’ll file for regulatory approval of its device later this year.
“This is an exciting day for Ocular Therapeutix as our sustained release drug delivery platform continues to provide strong data in our clinical trials in multiple indications,” said president and CEO Amar Sawhney, in a statement. “The ability to administer the entire course of therapy for post-operative inflammation and pain with a single dose would remove the onus from patients to follow complex pharmaceutical dosing regimens while providing the desired tapered therapeutic effect.”
This is the first big clinical test for Ocular since it went public in July. The company got a lukewarm reception from investors in its IPO, pricing 5 million shares at $13 apiece, a touch below its projected $14 to $16 per share range. But Ocular has climbed ever since; shares now trade at over $40 apiece.
The company makes tiny plugs that are inserted into the tear ducts and designed to release drugs over a period of weeks or months, which in theory would enable a patient to steer clear of more cumbersome treatments like the dexamethasone eye drops people have to take several times a day after cataract surgery. The plugs are mostly made of hydrogel, which is absorbed by the body after treatment. In addition to dexamethasone, Ocular is testing this system with other already-approved drugs, like the glaucoma treatment travoprost (Travatan) and the antibiotic moxifloxacin. A potential product for the “wet” form of age-related macular degeneration, a common cause of vision loss, is also in preclinical development.
Ocular also aims to start a Phase 3 trial of OTX-DP in pink eye, and has an exploratory Phase 2 test for inflammation in dry eye underway as well. The Phase 2 glaucoma study should produce results later this year.
In today’s study, meanwhile, Ocular said that 76.1 percent of cataract surgery patients on OTX-DP were pain-free after 8 days, compared to 36.1 percent of patients on placebo. The patients on drug saw inflammatory cells in the eye reduced by 33.7 percent at day 14 compared to day 1; those in the placebo group, 14.6 percent. Ocular said it’s still analyzing safety data from the study.
Ocular, founded in 2006, already has one product on the market, a hydrogel-based ophthalmic would sealant (ReSure Sealant) that the FDA approved in January 2014; it’s used to close up wounds from corneal incisions after cataract surgery. Versant Ventures (19 percent), Polaris Partners (16.2 percent), and SV Life Sciences (15.1 percent) were Ocular’s most significant shareholders before its July IPO.