Ocular Therapeutix, Inc. reports news around ophthalmic drug development, commercial product activity and corporate governance for a Nasdaq-listed biopharmaceutical company using ELUTYX proprietary bioresorbable hydrogel formulation technology. Recurring updates focus on AXPAXLI, also known as OTX-TKI, an axitinib intravitreal hydrogel candidate for retinal disease, including wet age-related macular degeneration and diabetic retinal disease such as non-proliferative diabetic retinopathy.
Company announcements also cover DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, as well as OTX-TIC, a travoprost intracameral hydrogel program for open-angle glaucoma or ocular hypertension. Other recurring items include financial results, scientific and investor conference participation, clinical-study presentations and inducement equity grants under Nasdaq Listing Rule 5635(c)(4).
Ocular Therapeutix (NASDAQ:OCUL) reported substantial growth in its Q2 2021 financial results, with net product revenue for DEXTENZA® escalating by nearly 700% year-over-year to $11.1 million. The company achieved record sales of nearly 25,000 billable units, a 50% increase from the previous quarter. Additionally, the first patient was dosed in the U.S. trial for OTX-TKI for wet AMD. However, the net loss decreased to $8.5 million from $36.6 million in the same period last year, reflecting improved financial conditions.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced the termination of its collaboration with Regeneron, effective August 5, 2021. The partnership, initiated in 2016, aimed to develop products using Ocular's sustained-release hydrogel technology and Regeneron's VEGF-targeting compounds. Despite the termination, Ocular's CEO expressed gratitude for the collaboration, highlighting valuable insights gained in hydrogel formulation and administration. Ocular continues to focus on its product pipeline, including DEXTENZA, with a PDUFA target date of October 18, 2021, for a supplemental application related to allergic conjunctivitis.
Ocular Therapeutix (NASDAQ:OCUL) has commenced a Phase 1 clinical trial in the U.S. for OTX-TKI, an intravitreal implant for treating wet age-related macular degeneration (wet AMD). This trial is notable for using a single 600 µg dose, potentially offering up to six months of durability versus existing treatments. Initial data from earlier Australian trials suggest OTX-TKI shows acceptable tolerability and preliminary activity. The trial will compare the new implant with aflibercept, aiming to evaluate safety and biological activity across 20 subjects.
Ocular Therapeutix (Nasdaq: OCUL) will report its second quarter financial results on August 9, 2021. The management team will conduct a live conference call and webcast at 4:30 p.m. ET following the earnings release to discuss results and provide a business update. The webcast can be accessed via the company's website, and a call-in option is available for participants. The company’s lead product, DEXTENZA®, is an FDA-approved drug for ocular conditions, with a supplemental application pending for ocular itching related to allergic conjunctivitis, expected for review by October 18, 2021.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) showcased significant advancements at the 2021 ASCRS Annual Meeting from July 23-27 in Las Vegas. Presentations focused on DEXTENZA® for treating post-operative ocular inflammation and pain, as well as ReSure® Sealant to prevent wound leaks. The company highlighted data supporting DEXTENZA's efficacy and ongoing pipeline developments including treatments for glaucoma, dry eye disease, and allergic conjunctivitis. The PDUFA target action date for DEXTENZA's supplemental application is set for October 18, 2021.
Ocular Therapeutix (NASDAQ:OCUL) reported preliminary net product revenue of approximately $11.7 million for Q2 2021, reflecting a 600% year-over-year increase. Net revenue from DEXTENZA® accounted for $11.1 million, while ReSure® Sealant contributed $0.6 million. In-market sales of DEXTENZA reached 24,990 units, a 50% increase from Q1 2021, driven by rising cataract procedures. The company anticipates reporting full financial results on August 9, 2021.
Ocular Therapeutix (NASDAQ:OCUL) has entered a collaboration with Mosaic Biosciences to discover new therapeutic targets for Dry Age-related Macular Degeneration (dAMD). This partnership focuses on developing novel complement inhibitors, which play a crucial role in immune response relevant to ocular health. Ocular will fund the research and retain all program inventions. AMD impacts 11-15 million adults in the U.S., with the dry form being the most common and currently lacking FDA-approved treatments. This collaboration aims to enhance Ocular's innovative ophthalmic product portfolio.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) announced its participation in three key healthcare conferences in June 2021. The events include the Jefferies Virtual Healthcare Conference on June 1, The JMP Securities Life Sciences Conference on June 16, and the Raymond James Healthcare Conference on June 23. Management will hold virtual investor meetings throughout these conferences. Additionally, Ocular Therapeutix is awaiting a PDUFA target action date of October 18, 2021, for DEXTENZA, which aims to treat ocular itching related to allergic conjunctivitis.
Ocular Therapeutix (NASDAQ:OCUL) reported robust first-quarter 2021 results, with DEXTENZA® net revenue soaring by 220% year-over-year to $6.7 million. Quarterly in-market sales reached over 16,000 units, marking a 15% sequential growth. The company anticipates ongoing momentum with estimated April sales exceeding 8,000 units. Key clinical advancements were highlighted at the ARVO meeting, including updates on OTX-TKI and OTX-DED programs. Net income for the quarter was $3.1 million, driven by a non-cash gain, while R&D expenses increased to $10.9 million.
Ocular Therapeutix confirmed completion of all FDA post-approval study requirements for its ReSure® Sealant, approved in 2014 for cataract surgeries. The Device Exposure Registry Study showed no significant difference in endophthalmitis rates between sites using ReSure (0.609 per 1,000 surgeries) and those without (0.660 per 1,000 surgeries). Ocular plans to update the ReSure label to reflect these findings. This development strengthens the product's standing among surgeons.