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Ocular Therapeutix Ocular Therapeutix ™ M Reports First Quarter 2021 Financial Results and Business Update May 5 , 2021 DEXTENZAⓇ Achieved Quarterly Record of 16,634 Billable Units Sold to End Customers , Representing Quarterly Sequential Growth of 15 % . BEDFORD , Mass .-- ( BUSINESS WIRE ) -- May 5 , 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 first quarter of 2021 , and provided updates on its strong ophthalmology pipeline . " Our progress in the first quarter of 2021 was significant , " said Antony Mattessich , President and Chief Executive Officer . " Revenue for DEXTENZAⓇ was up over 200 % against the prior year period and we achieved record quarterly , in - market sales in excess of 16,000 billable units , representing 15 % sequential quarterly growth . Encouragingly , the momentum we saw in the first quarter has continued into the second quarter with estimated sales in excess of 8,000 billable units in April alone . Beyond DEXTENZA , we have made progress in advancing our pipeline of product candidates that continue to show potential to set the standard of care in their respective disease areas . We have had a large presence at this year's ongoing ARVO meeting with seven total presentations highlighting both pre - clinical and clinical updates in our key programs . In 2021 we look forward to continued momentum with DEXTENZA and further development of our pipeline which includes the planned initiation of two Phase 2 programs in wet - AMD and glaucoma and the expected completion of a Phase 2 clinical trial in dry eye disease . " Recent Business Updates Presented Pre - Clinical and Clinical Data at the 2021 Association for Research in Vision and Ophthalmology ( ARVO ) Annual Meeting . Six company presentations and one presentation from an investigator - initiated trial are being held at the 2021 Association for Research in Vision and Ophthalmology ( ARVO ) Virtual Meeting this week . Updated interim analyses of Phase 1 data for both OTX - TKI for the treatment of wet age - related macular degeneration ( wet AMD ) and other retinal diseases and OTX - TIC for the reduction of intraocular pressure in patients with primary open - angle glaucoma or ocular hypertension were presented . Both presentations provided additional data that continue to support the development of products that could become the standard of care in these large markets . Data are also being presented on the Company's products targeting ocular surface disease including pre - clinical pharmacokinetic data on OTX - CSI for the chronic treatment of dry eye disease and OTX - DED for the short - term treatment of signs and symptoms of dry eye disease . Additionally , we are presenting a post - hoc analysis of data on DEXTENZAⓇ ( dexamethasone ophthalmic insert ) for the treatment of allergic conjunctivitis . The use of DEXTENZA in allergic conjunctivitis is currently under U.S. Food and Drug Administration ( FDA ) review with a target action Prescription Drug User Fee Act ( PDUFA ) date of October 18 , 2021. This presentation evaluates the safety of the product candidate across the four clinical trials conducted . U.S. Commercial Uptake of DEXTENZA . Net product revenue of DEXTENZAⓇ for the quarter was $ 6.7 million , an approximately 220 % increase over the first quarter of 2020. Net sales for the quarter were flat relative to the previous quarter primarily due to variations in distributor inventory levels . DEXTENZA in - market unit volume to surgery centers , which is the best determinant of true underlying demand , achieved a record in the first quarter of 16,634 billable inserts and grew at approximately 15 % sequentially over the previous quarter . As previously reported , January and February in - market billable inserts were 4,582 and 4,901 , respectively . In - market demand then rebounded strongly in March with sales of billable inserts achieving a record month of 7,151 units . The Company is also reporting that April in - market , billable units are estimated to have exceeded 8,000 units , setting a new monthly record . Dosed First Patient in Phase 2 Clinical Trial Evaluating OTX - DED ( dexamethasone intracanalicular insert ) . The Phase 2 clinical trial is a U.S. - based , prospective , randomized , double - masked , vehicle - controlled , multi - center trial evaluating two different formulations of a new dexamethasone drug product candidate OTX - DED in approximately 150 subjects with dry eye disease . Subjects are to be followed for approximately two months after randomization . This trial is designed to assess the safety and efficacy of OTX - DED for the short - term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia , the visual analog score of eye dryness and severity , and total corneal fluorescein staining . Key Program Updates • OTX - TKI ( axitinib intravitreal implant ) for the potential treatment of wet AMD and other retinal diseases . • The Company filed an exploratory IND ( eIND ) in November 2020 to initiate a Phase 1 clinical trial of OTX - TKI in the United States . A planned U.S. - based Phase 1 clinical trial is anticipated to start in mid - 2021 . • OTX - TIC ( travoprost intracameral implant ) for the treatment of patients with primary open - angle glaucoma or ocular hypertension . • The Company completed enrollment of all four cohorts of its Phase 1 clinical trial . o The Company plans to initiate a randomized , double - masked , active - controlled Phase 2 clinical trial in the fourth quarter of 2021 in the United States with a total of approximately 105 subjects to evaluate two different formulations of OTX - TIC versus a control arm receiving Durysta ™ . • OTX - CSI ( cyclosporine intracanalicular insert ) for the chronic treatment of dry eye disease . • The Company has completed enrollment of a U.S. - based Phase 2 , randomized , double - masked , multi - center clinical trial to evaluate the safety , efficacy , durability , and tolerability of two different formulations of OTX - CSI versus hydrogel vehicle insert .