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. (NASDAQ: OCUL) generates frequent news as an ophthalmology-focused biopharmaceutical company advancing late-stage retinal programs and a commercial eye-care product. Its press releases highlight progress across the AXPAXLI (OTX-TKI) clinical programs in wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR), as well as updates related to DEXTENZA, financings, and corporate events.
News coverage for OCUL commonly includes clinical milestones such as target randomization in the SOL-R Phase 3 wet AMD trial, completion of randomization in SOL-1, and the initiation or advancement of the HELIOS Phase 3 registrational program in NPDR. The company also issues announcements about regulatory strategy, including Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration for SOL-1 and HELIOS-2 and plans to leverage the 505(b)(2) pathway for AXPAXLI in wet AMD.
Investors following OCUL news will see regular business and capital markets updates, such as underwritten equity offerings, cash runway disclosures, and inducement equity grants under Nasdaq Listing Rule 5635(c)(4). The company also reports quarterly financial results and business highlights, describing clinical execution, trial timelines, and planned extension studies like SOL-X for long-term evaluation of AXPAXLI in wet AMD.
In addition, Ocular Therapeutix announces participation in scientific and investor conferences, where it presents data from earlier-stage trials (for example, HELIOS Phase 1 results in NPDR) and discusses its strategy to "redefine the retina experience." For a consolidated view of these developments, the OCUL news page on Stock Titan brings together clinical, regulatory, financial, and corporate communications so readers can track how trial outcomes, regulatory interactions, and financing activities may shape the company’s ophthalmic pipeline and commercial portfolio over time.
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.
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.