Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication.
Bedford, Mass.-based Ocular Therapeutix has had mixed results with Dextenza, formerly known as OTX-DP, which is designed to deliver sustained dosage of dexamethasone over 4 weeks, using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.
In March, Ocular said a 1st, 247-patient trial examining Dextenza for reducing pain and inflammation after cataract surgery showed that 33.7% of the Dextenza arm showed no inflammatory cells after 14 days, compared to 14.6% for the placebo control arm. Some 76.1% of patients receiving the drug reported no pain after 8 days, compared to 36.1% of the placebo arm.
But Dextenza failed to meet a key endpoint the 2nd clinical trial for the pain & inflammation indication, the company said in April. The 240-patient trial met its pain endpoint but missed the inflammation endpoint. Although 77.5% of patients in the Dextenza arm reported no pain after 8 days, compared with 58.8% of the control arm, the difference in inflammatory cell counts after 14 days was not statistically significant (39.4% vs. 31.3%), the company said, noting that both endpoints had to be met to consider the study a success.
Founder & CEO Amar Sawhney said Ocular is also pursuing a new drug application for Dextenza in treating post-surgical ocular pain; top-line results from a Phase II study for inflammatory dry eye are expected before the end of the year, Sawhney said.
“The start of another Phase III clinical trial for Dextenza demonstrates our commitment to applying our proprietary, hydrogel platform to additional indications where patients can benefit from sustained-release therapies,” he said. “We are pleased to advance the Dextenza platform in allergic conjunctivitis, with the goal of providing patients with one-time, seasonal therapy that is preservative-free. For the first time, Dextenza offers the potential for full-season relief to the patient, as a product candidate designed to both treat ocular itching for 4 weeks and offer prophylaxis against allergic conjunctivitis.”
The new allergic conjunctivitis trial is designed to compare Dextenza with a placebo using 4 series of allergen challenges over 30 days, with the treatment or control administered 48 to 72 hours after exposure. The sole primary endpoint is ocular itching at day 7, Ocular said.
Top-line data from the 1st allergic conjunctivitis Phase III, released last month, showed that Dextenza met the primary endpoint of itching. The trial failed to meet the 2nd endpoint, conjunctival redness, although the company noted at the time that FDA hasn’t required conjunctival redness for approval in other allergic conjunctivitis trials.
If Dextenza meets the itching endpoint in the 2nd trial, Ocular said it expects to submit an NDA to the FDA for an indication of ocular itching associated with allergic conjunctivitis (depending on how things go for the post-surgical pain NDA, that is).
