Welcome to our dedicated page for Ocular Therapeutix news (Ticker: OCUL), a resource for investors and traders seeking the latest updates and insights on Ocular Therapeutix stock.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company dedicated to enhancing vision and quality of life through the development, manufacturing, and commercialization of innovative ocular therapies. The company employs its proprietary hydrogel-based formulation technology to address various diseases and conditions affecting the eye.
The company's lead product, DEXTENZA® (dexamethasone insert), an FDA-approved corticosteroid, is designed for intracanalicular use to treat ocular inflammation and pain following ophthalmic surgery and ocular itching due to allergic conjunctivitis. DEXTENZA delivers dexamethasone to the ocular surface for up to 30 days without preservatives, resorbing naturally, eliminating the need for removal.
Ocular Therapeutix’s pipeline includes several promising candidates. OTX-TIC (travoprost intracameral implant) is in Phase 2 trials for treating open-angle glaucoma and ocular hypertension. Another key candidate is AXPAXLI™ (axitinib intravitreal implant), currently in Phase 3 trials for wet age-related macular degeneration (AMD) and Phase 1 trials for non-proliferative diabetic retinopathy (DR). The company also has OTX-CSI (cyclosporine intracanalicular insert) and OTX-DED (dexamethasone intracanalicular insert) for dry eye disease.
Recently, Ocular Therapeutix announced positive Phase 1 results for AXPAXLI in diabetic retinopathy, accelerating its development to Phase 3. Moreover, recent strategic changes include the appointment of Dr. Pravin U. Dugel as the CEO, aiming to transform the company into a leading retina-focused biopharmaceutical entity.
Ocular Therapeutix has secured significant partnerships and funding to support the clinical development of its robust pipeline. These include a licensing agreement with AffaMed Therapeutics for the commercialization of DEXTENZA in Greater China and ASEAN markets.
Follow Ocular Therapeutix for the latest updates on their innovative pipeline and corporate developments via their website, LinkedIn, and Twitter.
AffaMed Therapeutics announced the approval from China's National Medical Products Administration to start a Phase 3 clinical trial for DEXTENZA, targeting ocular inflammation and pain after ophthalmic surgery. This follows DEXTENZA's recent approval in Macau for treating ocular itching from allergic conjunctivitis. The licensing agreement with Ocular Therapeutix in October 2020 covers development in Greater China, South Korea, and parts of ASEAN. DEXTENZA is noted for its compliance benefits, requiring a single administration for up to 30 days. AffaMed plans to commence this pivotal study shortly, aiming to enhance treatment options in China.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation at the ARVO Annual Meeting from April 23-27, 2023, showcasing significant clinical and pre-clinical data related to its innovative hydrogel therapies for eye diseases. Chief Medical Officer Rabia Gurses-Ozden emphasized the importance of their drug delivery platform, particularly for conditions affecting the front and back of the eye. Key presentations include updates on the OTX-TKI, an axitinib intravitreal implant for wet AMD, showing interim results from ongoing trials. Other topics involve OTX-TIC for glaucoma and advancements in their early-stage gene therapy pipeline. The presentations aim to highlight the efficacy and safety of their products, positioning Ocular Therapeutix for future growth.
Ocular Therapeutix (NASDAQ:OCUL) reported its financial results for Q4 and the full year 2022, achieving total net revenue of $51.5 million, an 18% increase from the previous year. Fourth-quarter net revenue was $14.1 million, also up 18%. The company highlighted progress in its clinical pipeline, notably with interim data from a Phase 1 trial of OTX-TKI for wet AMD, showing a 73% rescue-free rate maintained at 10 months. DEXTENZA, another key product, generated $13.9 million in Q4 revenue, marking a 17% quarter-over-quarter growth. The company forecasts DEXTENZA revenue for 2023 between $55 and $60 million, a 10% to 20% year-over-year growth.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that its President and CEO, Antony Mattessich, will participate in a fireside chat at Cowen’s 43rd Annual Healthcare Conference on March 7, 2023, at 1:30 PM EST. Investors wishing to meet with Ocular Therapeutix management during the conference should contact their Cowen representative. A live webcast of the presentation will be available on the company’s website.
The company focuses on developing innovative therapies for eye diseases and conditions, including DEXTENZA®, an FDA-approved corticosteroid. It is also advancing multiple assets in clinical trials for various eye conditions.
Ocular Therapeutix (NASDAQ: OCUL) will announce its fourth quarter and year-end financial results on March 6, 2023, after market close. CEO and management will discuss these results in a conference call at 4:30 PM ET. Investors can access the live webcast through a provided link. Ocular Therapeutix specializes in innovative therapies for eye conditions, with its flagship product, DEXTENZA®, an FDA-approved corticosteroid for treating ocular inflammation. The company is also developing other treatments currently in various clinical trial phases.
Ocular Therapeutix (NASDAQ:OCUL) announced promising interim results from its U.S. Phase 1 clinical trial of OTX-TKI, an axitinib hydrogel implant for treating wet age-related macular degeneration (wet AMD). At the 10-month mark, 73% of subjects remained rescue-free, demonstrating an impressive 92% reduction in treatment burden. The data showed that OTX-TKI was generally well tolerated, with no serious adverse events reported. Best corrected visual acuity (BCVA) and central subfield thickness (CSFT) measures were comparable to those receiving aflibercept. The company plans to meet with the FDA to discuss future trials and potential strategic alliances.
Ocular Therapeutix (NASDAQ:OCUL) reported a strong performance for DEXTENZA, with fourth quarter 2022 net product revenue estimated at $13.6 million, marking a growth of 14% from the previous quarter and 11% year-over-year. For the full year, revenue is estimated at $50.2 million, reflecting a 20% increase from 2021. The company is advancing clinical trials for OTX-TKI (for wet AMD and diabetic retinopathy) and OTX-TIC (for glaucoma), with key data expected in 2023.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation in several upcoming conferences. These include the Jefferies London Healthcare Conference on
Ocular Therapeutix (OCUL) reported positive interim results from its Phase 1 trial of OTX-TKI for wet AMD, with 80% of subjects rescue-free at 6 months. The company plans to initiate a Phase 1 trial for diabetic retinopathy in Q1 2023 and a Phase 2/3 trial for wet AMD in Q3 2023. DEXTENZA revenue reached $11.9 million in Q3, with annual guidance revised to $48-$52 million, reflecting 10%-20% growth. The company reported a net loss of $24.2 million, leading to a loss per share of $(0.31). Cash and equivalents stood at $121 million, indicating sufficient funds through 2023.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) will report its third quarter financial results for the period ended September 30, 2022, after market close on November 7, 2022. A live conference call and webcast will follow at 4:30 p.m. ET to discuss these results and provide a business update. Key developments include FDA-approved DEXTENZA® for ocular conditions and ongoing clinical trials for multiple innovative drug candidates targeting various eye diseases, including wet AMD and glaucoma.
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