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Therapeutix ™ Ocular Therapeutix ™ Reports Third Quarter 2021 Financial Results and Business Update November 8 , 2021 DEXTENZA® ( dexamethasone ophthalmic insert ) 0.4 mg Recorded Net Quarterly Sales of $ 11.9 Million , Representing Year - Over - Year Growth of 120 % FDA Approved Supplemental New Drug Application ( SNDA ) for DEXTENZA for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis DEXTENZA Will Be Paid Through the End of 2022 and is Eligible for Separate Payment in the Ambulatory Surgery Center Beyond 2022 Conference Call to Discuss Third Quarter Results to be Held at 4:30 p.m. ET BEDFORD , Mass .-- ( BUSINESS WIRE ) -- Nov . 8 , 2021-- 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 reported financial results for the third quarter of 2021 , and provided updates on its ophthalmology pipeline . " The previous four months have been an exceptionally busy time at Ocular , " said Antony Mattessich , President and Chief Executive Officer . " We had a couple of positive outcomes that we believe will set the course for the future of DEXTENZA® . The first was the approval of the sNDA for itching associated with allergic conjunctivitis that opens a large , new and discrete opportunity for DEXTENZA in the office setting . The second was Medicare's final rule that determined that DEXTENZA will be paid separately in the hospital outpatient and ASC settings in 2022 and is eligible under the current criteria for separate payment in the ASC as a non - opioid pain management drug beyond 2022 , positioning our vibrant business in the surgical setting to grow into the foreseeable future . We also continued to advance our pipeline . While we were disappointed with the outcome of our Phase 2 dry eye clinical trial with OTX - CSI , we expect to announce the Phase 2 clinical trial topline results for OTX - DED , our clinical trial in episodic dry eye disease in the first quarter of 2022. Further , our U.S. - based clinical trial of OTX - TKI in wet - AMD is enrolling well , and we expect to initiate a Phase 2 clinical trial for OTX - TIC in glaucoma by the end of the year . Overall , we are pleased with our continued progress as we enter a period of significant data and news flow that will shape our leadership position within ophthalmology . " Recent Business Updates FDA Approved Supplemental New Drug Application ( SNDA ) for DEXTENZA® ( dexamethasone ophthalmic insert ) 0.4 mg for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis . The approval represents the second label expansion for DEXTENZA and makes it the first FDA - approved , physician - administered intracanalicular insert capable of delivering a preservative - free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days . Allergic conjunctivitis represents the Company's first indication that will primarily be prescribed by physicians within the office setting and begins to lay the commercial foundation for additional potential pipeline product candidates to be used to treat patients in that setting . Received Final Rules for the Outpatient Prospective Payment System ( OPPS ) and Medicare Physician Fee Schedule ( MPFS ) from the Centers for Medicare and Medicaid ( CMS ) . • The OPPS final rule confirms that DEXTENZA will continue to be separately paid by Medicare in the ambulatory surgical center ( ASC ) and hospital outpatient department ( HOPD ) settings for 2022. CMS further indicated that DEXTENZA is eligible to receive separate payment in the ASC setting because it meets the criteria set forth in the non - opioid as a surgical supply provision , which is favorable for 2023 and beyond . • The MPFS final rule establishes payment for Category I Current Procedural Terminology ( CPT ) Code 68841 , which replaces Category III CPT Code 0356T , effective January 1 , 2022. The physician payment for the insertion of DEXTENZA in the physician office is $ 37.29 and in the ASC or the HOPD is $ 31.58 . The Company believes achieving Category I status for the new CPT Code represents an important milestone because , although the procedure payments are reduced in some locations , Category I codes standardize payment and are more widely accepted by the payer community , resulting in broader coverage . The U.S. Commercial Uptake of DEXTENZA . Net product revenue of DEXTENZA® for the quarter was $ 11.9 million , a 120 % increase over the third quarter of 2020 and a 7 % sequential improvement over the second quarter of 2021. The Company believes that DEXTENZA recorded a solid third quarter performance in light of lower than anticipated elective surgery volumes due to COVID - 19 . While it is early in the fourth quarter , monthly growth in ASC volumes appears to be coming back on track as the Company estimates sales of in - market sales of over 9,600 billable units in October , its second - largest month ever . In - market sales of billable units were 6,924 , 9,321 and 8,737 for the months of July , August and September respectively . Announced Results from Phase 2 Clinical Trial Evaluating OTX - CSI ( cyclosporine intracanalicular insert ) for the Treatment of Dry Eye Disease . The Phase 2 clinical trial of OTX - CSI was designed to evaluate the safety , tolerability , durability , and efficacy of two different formulations of OTX - CSI by measuring signs and symptoms of dry eye disease in 140 subjects treated in both eyes over approximately 16 weeks ( a 12 - week study period , with an additional 4 - week safety follow - up ) . The Phase 2 study did not show separation between the OTX - CSI treated subjects ( both formulations ) and the vehicle - treated subjects ( both formulations ) for the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer's Test . All formulations of OTX - CSI were observed to have a generally favorable safety profile and were well tolerated . The Company is continuing to analyze the data , including retention data showing lower than anticipated insert retention rates in the active drug groups .