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) 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.
Ocular Therapeutix (NASDAQ:OCUL) announced interim results from its U.S. Phase 1 trial of OTX-TKI, an axitinib hydrogel implant for treating wet AMD. The trial involved 21 subjects and showed OTX-TKI was well tolerated with no serious drug-related adverse events. At 7 months, subjects demonstrated stable best corrected visual acuity and central subfield thickness. Notably, 80% were rescue-free for 6 months and 73% for 7 months. The company plans to discuss next steps with the FDA and may initiate a Phase 2 trial in Q3 2023.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its significant presence at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting, held from September 30 to October 3, 2022, in Chicago, IL. The company will present key findings, including 28-week data on its Phase 1 trial of OTX-TKI for Wet AMD. Presentations include podium talks and ePosters on various ophthalmic conditions, emphasizing their product candidates like DEXTENZA and OTX-TKI. Ocular Therapeutix is focused on innovative therapies for eye diseases using hydrogel technology.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 11:00 AM ET in New York City. The management will also host investor meetings during the conference. Interested investors can contact H.C. Wainwright to arrange meetings. A live webcast of the presentation will be available on the company's Investors website and can be replayed for 90 days. Ocular Therapeutix focuses on innovative therapies for eye diseases, including its FDA-approved product DEXTENZA®.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announces its participation in the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference on August 17, 2022. The agenda includes a pre-recorded corporate presentation at 7:00 AM ET and a panel discussion at 11:00 AM ET focusing on unique delivery technology platforms. Investor meetings will also take place on the same day. Webcast access will be available on the company’s website for 90 days. Ocular Therapeutix specializes in innovative therapies for eye diseases, including the FDA-approved DEXTENZA® and several other promising treatments in clinical trials.
Ocular Therapeutix (NASDAQ:OCUL) reported Q2 2022 financial results, with net product revenue for DEXTENZA at $12.1 million, a 9% increase year-over-year. The company reiterated its 2022 revenue guidance of $55 to $60 million, projecting annual growth of 26% to 38%. A conference call to discuss results is scheduled for 4:30 p.m. ET. The company is also set to present interim data from its Phase 1 clinical trial of OTX-TKI for wet AMD at the AAO in Q3 2022.
Despite staffing challenges impacting operations, Ocular aims for improved DEXTENZA sales through new strategies and upcoming data presentations.