04.13.20

Ocular Therapeutix Provides Business Update and Response to COVID-19 Global Pandemic

Source: Ocular Therapeutix

Ocular Therapeutix announced its response to the COVID-19 pandemic and related impact on Ocular Therapeutix’s business operations.

“In the midst of the global COVID-19 pandemic, our first priority is for the safety and well-being of our employees, patients, clinical collaborators and customers,” Antony Mattessich, President and Chief Executive Officer, said in a company news release. “While we are doing everything in our power to respond appropriately to the current crisis, we are also preparing Ocular Therapeutix and our community of stakeholders to thrive in the future. The company is well positioned despite the challenging economic conditions.

  • Our clinical programs remain on track:
    • The first two subjects in the higher-dose cohort of our OTX-TKI (axitinib intravitreal implant) phase 1 clinical trial have reached the four-and-a-half-month time point and are continuing to show clinically meaningful reductions in intraretinal and/or subretinal fluid with a single implant. If the durability of OTX-TKI is confirmed in larger trials out to this time point or beyond, we believe that it would have the potential to become a new standard of treatment for wet AMD;
    • Our Phase 3 trial of Dextenza for the treatment of ocular itching associated with allergic conjunctivitis (AC) is expected to read out this quarter and, if successful, we plan to file an sNDA application for this indication;
    • The first three cohorts of our phase 1 program for OTX-TIC (travoprost intracameral implant) are fully enrolled and we look forward to providing updates on the results of those patients in the near future; and
    • OTX-CSI (cyclosporine intracanalicular insert) is set to enter the clinic in the middle of 2020, continuing our development of a treatment for dry eye disease.
  • On the revenue side, despite a marked slow-down in cataract and other ophthalmic surgical procedures beginning in the second week of March due to COVID-19, we were able to record Dextenza net product revenue in Q1 of an estimated $2.1 million, representing growth of 31% over Q4 2019; and
  • Moving forward, while we anticipate substantial continued weakness in cataract volumes throughout Q2, we expect that, with variable expense reductions and a rebound in cataract volumes in Q3, our cash runway should extend into Q1 2021, consistent with our prior guidance.”

Clinical and Pipeline Update

OTX-TKI (axitinib intravitreal implant): OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties delivered by intravitreal injection to the posterior segment of the eye for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Two cohorts of six subjects each, a lower dose cohort of 200 µg and a higher dose cohort of 400 µg have been enrolled in a Phase 1 clinical trial.

  • As of early April 2020, the first two patients in the second or higher-dose cohort have now shown a clinically meaningful reduction in intraretinal and/or subretinal fluid out to four-and-a-half months with a single implant. Other patients in the second cohort are still being followed and have not reached these timepoints yet. As is typical of such early stage trials, visual acuity has not shown consistent improvement across the cohort.
  • Data from both cohorts continue to demonstrate that OTX-TKI has been generally well tolerated and is observed to have a favorable safety profile, with no ocular serious adverse events to date.
  • Interim data will be presented by Robert Avery, MD a member of the Phase 1 Data Safety Monitoring Committee, at the 8th Annual Vit-Buckle Society meeting on April 20, 2020.

OTX-TIC (travoprost intracameral implant): OTX-TIC is a long-acting travoprost intracameral implant in development for the treatment of patients with primary open angle glaucoma or ocular hypertension. The company presented interim phase 1 data on OTX-TIC at the Glaucoma 360 Conference held in San Francisco, CA in February 2020 from the first two cohorts enrolled.

  • Data from the first two fully enrolled cohorts (cohort 1 = 5 patients, cohort 2 = 4 patients) continue to indicate a clinically meaningful reduction in mean IOP values in patients receiving OTX-TIC.
  • The data also continue to show that the mean intraocular pressure (IOP) values remained lowered from baseline through and beyond the six-month study period in many patients and, in one patient, over 18 months.
  • Enrollment in the third patient cohort has been completed. Enrollment in the fourth cohort continues, while long-term evaluation remains ongoing in the first two cohorts.

OTX-CSI (cyclosporine intracanalicular insert): The company recently filed an IND and intends to begin a phase 1 clinical trial for the treatment of dry eye disease in the middle of 2020.

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