Ocular Therapeutix (NSDQ:OCUL) said today topline results from a Phase 2 clinical trial of its Dextenza drug-device combo used to treat inflammatory dry eye disease helped identify optimal patient populations for responders and future testing.
Bedford, Mass.-based Ocular Therapeutix said the trial aimed to examine measures appropriate for future clinical trials to evaluate the Dextenza, or other molecules, as a sustained release product for treating dry eye disease.
The randomized 43-patient trial, which was not powered for statistical significance, reported that Dextenza had a good safety profile and was tolerated by patients. No intraocular pressure spikes were noted, and the retention rate of the drug depots was 96% through 30-days. The company said that more safety data still needs to be analyzed.
“We are encouraged that Dextenza showed improvements in the important and highly relevant efficacy measures of total and inferior corneal staining in this exploratory study. It is apparent that Dextenza exhibited a global effect across all regions on the cornea, particularly the inferior region, which is generally considered to be the most susceptible region of the cornea for the onset of dry eye disease. We intend to advance this important clinical program to expand Dextenza’s potential for this highly unmet need. Inflammatory dry eye is 1 of the most common ophthalmic disorders affecting approximately 20 million people in the United States, for which novel treatments are needed. With the results from this exploratory trial, we are now positioned to pursue the further development of Dextenza for inflammatory dry eye disease,” CEO Amar Sawhney said in prepared remarks.
While not statistically significant, total corneal staining decreased in the Dextenza treated group at 30 days compared to the placebo group, at -3.14 and -1.10 respectively. Inferior corneal staining showed clinically significant changes from the baseline in the Dextenza group at -0.43 at day 15 and -0.45.
Ocular Therapeutix said that corneal staining has been used as a primary endpoint in recent phase 3 dry eye clinical trials conducted by other opthalmology companies studying dry eye disease.
Patients in the trial did not face any inclusion thresholds for symptoms of dry eye disease at the point of randomization, but the company said changes from the baseline reports of the symptoms of the disease ‘favored’ the patient groups treated with Dextenza.
Ocular Therapeutix said other points in the trial did not show a benefit over the placebo group, though the company said many measures were included to help identify which measures Dextenza showed benefits in compared to the placebo group for future clinical trials.
“Subject to further clinical testing, Dextenza may be able to satisfy an unmet need for our patients with dry eye disease with its dual mechanism of action, preservative free formulation, and rapid onset efficacy with minimal compliance or safety concerns,” principal investigator Dr. John Sheppard of Eastern Virginia Medical School said in a press release.