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.
Ocular Therapeutix has appointed Karen-Leigh Edwards as Senior Vice President of Technical Operations. With over 20 years of experience, she will oversee technical development, manufacturing, and quality operations. Edwards previously held senior roles at Alexion Pharmaceuticals, where she led global manufacturing strategies. The leadership believes her expertise will enhance the growth and value of Ocular's ophthalmic franchise, particularly with products like DEXTENZA and a robust pipeline of therapies nearing late-stage clinical development.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) reported strong sales for its DEXTENZA® billable inserts, with 9,321 units sold in August, marking the second-highest monthly sales figure to date. This follows the sale of 6,924 units in July. The company provides product revenues through authorized specialty distributors selling to medical facilities. Ocular Therapeutix focuses on innovative therapies for eye conditions, with DEXTENZA being its first commercial drug approved by the FDA for post-surgical ocular inflammation and pain. The company anticipates a significant PDUFA action date on October 18, 2021, for an additional indication for DEXTENZA.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The management team will host virtual investor meetings and a pre-recorded presentation will be available starting at 7:00 AM ET on September 13. Ocular Therapeutix focuses on innovative therapies for eye conditions, featuring its FDA-approved drug DEXTENZA®. A supplemental application for DEXTENZA is set for review on October 18, 2021, targeting ocular itching from allergic conjunctivitis.
Ocular Therapeutix (NASDAQ:OCUL) will participate in the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. They will present two panels: Surpassing the Standard of Care for Glaucoma at 7:00 AM ET and Emerging Therapeutics for Dry Eye Disease at 2:00 PM ET. Virtual investor meetings will also be held on the same day. A pre-recorded presentation will be available starting at 7:00 AM ET and can be replayed for 90 days via the company's investor website. The company is advancing innovative ocular therapies, with a PDUFA date of October 18, 2021, for DEXTENZA.
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.