Ocular Therapeutix™ Reports First Quarter 2020 Financial Results and Business Update

Presented Interim Clinical Data for OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity

Announced Positive Phase 3 Clinical Trial for DEXTENZA in Allergic Conjunctivitis; Plan to File sNDA with the U.S. Food and Drug Administration by the End of 2020

First Quarter DEXTENZA® Net Product Revenue of $2.1 million, a 31% Sequential Increase Compared with Fourth Quarter of 2019

BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the first quarter ended March 31, 2020 and provided a business update.

“The outlook for Ocular continues to brighten,” said Antony Mattessich, President and CEO. “As our development programs continue to perform in the clinic, changes in the regulatory and competitive landscapes give us even more confidence in our future. Successes in our clinical programs have us tracking toward target product profiles that could set the standard of care in disease areas like wet AMD, glaucoma, dry eye, and post-operative pain and inflammation while changes in the external environment make us more confident in the regulatory pathways and potential market acceptability of our programs. Similarly, concern over infection risk brought on by the COVID pandemic has sparked increased interest in truly “hands free” products like DEXTENZA that can replace 70 eye drops with a single physician-administered bioresorbable insert. As we see surgery centers and hospitals starting to schedule ophthalmic surgeries again, we are excited about our prospects of not only regaining but accelerating the momentum we saw through the middle of March for DEXTENZA.”

COVID-19 Update

• In March 2020, the Company enacted a mandatory “work from home” policy for employees and continues to comply with national and local guidelines.
• The Company has provided training for its staff in safety precautions and supplied personal protective equipment to ensure employee and customer safety as ambulatory surgery centers begin reopening.
• The Company believes there has been limited impact from COVID-19 to date on its ongoing clinical programs. Enrollment in the Phase 1 clinical trial of OTX-TIC in patients with primary open angle glaucoma or ocular hypertension has recently slowed but the Company believes enrollment in Cohort 4 will not be materially impacted and currently anticipates enrollment to pick up as ophthalmology practices begin to resume normal operations.
• The global COVID-19 pandemic has impacted recent DEXTENZA sales trends. Restrictions on cataract surgeries due to the pandemic significantly reduced our sales in late March. Despite recent elective surgery restrictions being lifted in certain geographies, the Company anticipates current guidelines and recommendations from the global health authorities will significantly impact revenue in the second quarter.

Key Program Updates

OTX-TKI (tyrosine kinase inhibitor intravitreal implant containing axitinib)

OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. The Company is currently running a Phase 1, prospective, multi-center, open-label, dose escalation clinical trial intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. Two cohorts of six subjects each have been enrolled, a lower-dose cohort of 200 ug and a higher-dose cohort of 400 ug.

• Interim data were 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.
• The first two patients in the second, or higher-dose, cohort have shown a clinically meaningful reduction in intraretinal and/or subretinal fluid out to four and half months with a single implant. Other patients in the second cohort continue to be evaluated and have yet to reach this timepoint. As is typical of such early stage trials, visual acuity has not shown consistent improvement across the cohort.
• If the durability and safety of OTX-TKI are confirmed in larger trials out to the four and half month time point or beyond, the Company believes that this product candidate, if approved, would have the potential to become a new standard of treatment for wet AMD.
• 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.
• The Company completed a protocol amendment in April 2020 to enroll a third cohort of patients to be dosed at 600 µg and anticipates commencing enrollment of the third cohort by the middle of the year.

OTX-TIC (intracameral travoprost implant)

OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension. The Company is currently enrolling a Phase 1, prospective, multi-center, open-label, dose escalation clinical trial which is intended to evaluate the safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension.

• 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 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 is completed. Enrollment in the fourth cohort has been initiated but, due to COVID-19, is experiencing temporary delays. The Company believes enrollment will pick-up as ophthalmic offices open back up for non-emergent patients by the end of the second quarter. Long-term evaluation remains ongoing in the first two cohorts.
• The Company believes there is an established clinical and regulatory pathway for OTX-TIC.

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg

DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

• U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA® in the first quarter ended March 31, 2020 of $2.1 million versus $1.6 million in the fourth quarter ended December 31, 2019, a 31% sequential increase. First quarter 2020 revenue was negatively impacted by a rapid deceleration of DEXTENZA orders in the second half of March due to COVID-19 and stoppage of elective surgical procedures at ambulatory surgery centers and hospitals. Despite recent elective surgery restrictions being lifted in certain geographies, the Company anticipates current guidelines and recommendations from the global health authorities will significantly impact revenue in the second quarter.

• DEXTENZA in Allergic Conjunctivitis. The Company announced positive topline results from its Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA® for the treatment of ocular itching associated with allergic conjunctivitis (AC).
  • DEXTENZA-treated subjects demonstrated a statistically significant difference in ocular itching scores (p