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Ocular Therapeutix ™ Ocular Therapeutix ™ Reports Second Quarter 2021 Financial Results and Business Update August 9 , 2021 DEXTENZAⓇ Recorded Net Quarterly Sales of $ 11.1 Million , Representing Quarterly Sequential Growth of Approximately 65 % Initiated First Clinical Trial in the U.S. to Assess a Single OTX - TKI Implant Containing a 600µg Dose of Axitinib for the Treatment of Wet Age - Related Macular Degeneration Conference Call to Discuss Second Quarter Results to be Held at 4:30 p.m. ET BEDFORD , Mass .-- ( BUSINESS WIRE ) -- Aug . 9 , 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 second quarter of 2021 , and provided updates on its ophthalmology pipeline . " It has been a productive quarter for Ocular as we work to build a leading ophthalmology company , " said Antony Mattessich , President and Chief Executive Officer . " Net product revenue for DEXTENZAⓇ was up nearly 700 % against the prior year period and we achieved record quarterly in - market sales of nearly 25,000 billable units , representing a 50 % sequential increase over the first quarter . Beyond DEXTENZA , we made significant progress in advancing our pipeline of product candidates , dosing the first patient in our U.S. - based trial of OTX - TKI , and completing a research agreement with Mosaic Biosciences targeting dry - AMD that further builds our product pipeline . In the second half of 2021 , we look forward to continued momentum with DEXTENZA , including a PDUFA date in allergic conjunctivitis in October , and further development of our pipeline which includes the expected completion of our Phase 2 clinical trial with OTX - CSI , our cyclosporine - containing intracanalicular insert for the chronic treatment of dry eye disease . " Recent Business Updates First Patient Dosed in U.S. - based Clinical Trial Evaluating OTX - TKI ( axitinib intravitreal implant ) for the Treatment of Wet AMD . The Phase 1 clinical trial in the U.S. is a prospective , randomized , controlled , multi - center trial evaluating a single OTX - TKI implant containing a 600 μg dose of axitinib with an anti - VEGF induction injection , compared with a 2 mg dose of aflibercept administered every 8 weeks in subjects previously treated with anti - VEGF therapy . This is the first clinical trial utilizing the Company's single dose , 600 µg implant . This trial is designed to assess the safety , tolerability , and biological activity of OTX - TKI for the treatment of wet AMD and is being conducted under an exploratory IND , at five sites with a total of 20 randomized subjects : 15 subjects being treated with a single OTX - TKI implant with an anti - VEGF induction injection , and 5 subjects being treated at eight - week intervals with a dose of aflibercept . OTX - TKI has the potential to be a novel sustained release administration of axitinib , with six months or longer durability , which includes a potential new mechanism of action for the treatment for patients with wet AMD and other retinal diseases . U.S. Commercial Uptake of DEXTENZA . Net product revenue of DEXTENZAⓇ for the quarter was $ 11.1 million , a nearly 700 % increase over the second quarter 2020 , and an approximately 65 % sequential increase over the first quarter of 2021. DEXTENZA in - market unit volume to surgery centers was a record of nearly 25,000 billable inserts , an approximately 50 % sequential increase over the previous quarter . The Company believes this growth reflects strong end - user demand for DEXTENZA driven by an increase in cataract procedure volumes and market share gains . June 2021 in - market unit sales set a monthly record of 9,779 billable inserts as cataract volumes continued to increase through the second quarter of 2021 after a slowing of procedures earlier in the year as result of regional COVID surges . As previously reported , April and May in - market unit sales were 8,025 billable inserts and 7,186 billable inserts , respectively . DEXTENZA Pass - Through Payment Status Recommended for Extension Through the End of 2022. CMS , in its CY 2022 Outpatient Prospective Payment System ( OPPS ) proposed rule on July 19 , 2021 , recommended that pass - through status of DEXTENZA be extended six months through the end of 2022. The Company expects that , if finalized , this decision would move any negotiation between the Company and CMS on DEXTENZA's post - pass - through payment status into the next rulemaking cycle , a year from now . The Company continues to believe there are a number of pathways whereby it can continue to provide patient access to DEXTENZA in ASCs and HOPDs beyond the pass - through period and expects to be working actively in advance of the 2023 rulemaking cycle . New Medicare Physician Fee Schedule Proposed for Insertion of DEXTENZA . The Medicare Physician Fee Schedule proposed rule was also issued in July . The proposed rule indicated that the Company's CPT procedural code , 0356T for the Insertion of a drug - eluting implant into the lacrimal canaliculus , continues to be on track to convert to a Category 1 code in January of 2022 with a proposed procedure payment of $ 31.91 in the facility and $ 37.61 in the physician's office for unilateral insertion . The Company is pleased with the prospect of the Category 1 code conversion for the procedure since Category 1 CPT codes typically benefit from broader coverage and payment among all types of payers . However , the Company intends to use the formal comment period to actively pursue higher potential payment rates that it believes are well justified . Presented Clinical Data at the 2021 American Society of Cataract and Refractive Surgery ( ASCRS ) Meeting . Eight company presentations and five presentations from investigator - initiated trials were presented at the 2021 ASCRS Meeting on July 23-27th . Data was presented on multiple programs advancing in clinic as well as DEXTENZAⓇ ( dexamethasone ophthalmic insert ) 0.4 mg for intracanalicular use and ReSureⓇ Sealant . The data being presented continue to support the use of DEXTENZA to treat post - operative ocular inflammation and pain and the ability to research the use of our proprietary hydrogel technology to potentially address the unmet needs in the ophthalmic space , specifically in glaucoma , dry eye disease and allergic conjunctivitis . Posters for the Company - sponsored presentations can be accessed on the corporate website . Regeneron Collaboration to Develop a Sustained - Release Formulation of Aflibercept for the Treatment of Wet AMD and other Serious Retinal Diseases Terminated . Regeneron has terminated its collaboration with the Company . The collaboration with Regeneron was initially formed in 2016 , and later amended in 2020 to focus on the research and development of an extended - delivery formulation of aflibercept to be delivered to the suprachoroidal space for the treatment of retinal diseases . Ocular is now free to potentially pursue discovery work in this area on its own or with a