Welcome to our dedicated page for Ocular Therapeut news (Ticker: OCUL), a resource for investors and traders seeking the latest updates and insights on Ocular Therapeut stock.
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, 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.
Ocular Therapeutix (NASDAQ:OCUL) announced its participation in the ARVO Annual Meeting featuring presentations on key programs, notably OTX-TKI for wet AMD and OTX-TIC for glaucoma, with advances towards Phase 2 clinical trials. Presentations include safety studies of corticosteroids post-cataract surgery and pharmacokinetics of various hydrogel-based implants. The FDA has set a PDUFA date of October 18, 2021, for DEXTENZA to treat allergic conjunctivitis, enhancing its market potential. The company's hydrogel technology aims to provide innovative treatments for eye diseases.
Ocular Therapeutix (Nasdaq: OCUL) will announce its first quarter financial results on May 5, 2021, followed by a live conference call at 4:30 p.m. ET. The management team will discuss the financial performance and business updates. Investors can access the webcast on the company's website or call in using provided numbers. The company is focused on developing innovative eye therapies, including its FDA-approved product DEXTENZA, which is set for additional indication review on October 18, 2021.
Ocular Therapeutix (NASDAQ:OCUL) reported its financial results for Q4 2020, highlighting significant commercial and clinical advancements. DEXTENZA® sales exceeded 14,000 units, marking over 40% sequential growth. The company showcased promising interim data from Phase 1 trials of OTX-TKI and OTX-TIC, indicating favorable safety and preliminary effectiveness. Additionally, a Phase 2 trial for OTX-DED was initiated. DEXTENZA's Q4 net revenue reached $6.9 million, a 28% increase from Q3, bolstered by rising surgical volumes and new account growth. The FDA set a PDUFA date of October 18, 2021, for DEXTENZA's sNDA review.
Ocular Therapeutix (Nasdaq: OCUL) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg to treat ocular itching from allergic conjunctivitis. The action date is set for October 18, 2021. If approved, this indication would expand DEXTENZA's use beyond post-surgical inflammation and potentially tap into a market of 10 million patients annually in the U.S. The company emphasizes that DEXTENZA offers a preservative-free method for steroid delivery, addressing significant medical needs.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) has initiated dosing in its Phase 2 clinical trial of OTX-DED, a dexamethasone ophthalmic insert, aimed at treating dry eye disease. This trial will evaluate two formulations in approximately 150 subjects. OTX-DED is designed to offer effective treatment without preservatives that can cause ocular surface toxicities. The dry eye market is valued at around $5 billion globally, presenting significant commercial potential. This study marks a critical step in the company's efforts to address the unmet needs in dry eye management.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) will report its fourth quarter and year-end financial results on March 11, 2021. The management team will hold a live conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update. Ocular Therapeutix is known for developing innovative therapies for eye conditions, including the FDA-approved DEXTENZA for treating post-surgical inflammation and pain. The company is advancing multiple products through clinical trials, including treatments for dry eye disease and retinal diseases.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) will participate in three upcoming conferences. The Cowen 41st Annual Health Care Conference will be on March 1, 2021, with a fireside chat at 12:30 PM ET. The Raymond James 42nd Annual Institutional Investors Conference is set for March 3, 2021, at 9:10 AM ET. The H.C. Wainwright Global Life Sciences Conference occurs on March 9-10, 2021, with a pre-recorded presentation available on March 9 at 7:00 AM ET. Investors can access webcasts and presentations via the company's investor website.