Clearside Biomedical, Inc. - CLSD STOCK NEWS

Arctic Vision, a China-based biotech, has amended its exclusive license agreement with Clearside Biomedical (CLSD) to expand the territory for ARVN001 (XIPERE™) to include ASEAN countries and India. This proprietary corticosteroid suspension targets macular edema associated with uveitis. The U.S. FDA accepted Clearside's NDA filing for XIPERE in May 2021, while Arctic Vision plans to start a Phase III clinical trial in China in late 2021. The expansion aligns with Arctic Vision's strategic goals to enhance its commercial reach in Asia.

Clearside Biomedical (NASDAQ:CLSD) announced progress in its clinical trials and financial results for Q2 2021. Key highlights include the initiation of Cohort 2 enrollment in the OASIS Phase 1/2a trial for wet AMD, achieving safety endpoints in Cohort 1. The FDA set a PDUFA date of October 30, 2021, for XIPERE's NDA review, aiming to treat macular edema associated with uveitis. For Q2 2021, Clearside reported revenues of $0.8 million, up from $0.4 million in Q2 2020, alongside a net loss of $6.1 million, or $0.11 per share, compared to $5.8 million, or $0.13 per share, in the previous year.

Clearside Biomedical, Inc. (NASDAQ:CLSD) announced that its executives will participate in two investor conferences in August 2021. George Lasezkay and Thomas A. Ciulla will speak at the Wedbush PacGrow Healthcare Virtual Conference on August 11 at 9:45 am ET, discussing Goldeneye. They will also participate in the H.C. Wainwright Ophthalmology Virtual Conference on August 17 at 12:00 pm ET, addressing Vision Repair Beyond Traditional Anti-VEGF Therapy. Archived webcasts will be available for three months on the Clearside website.

Clearside Biomedical, Inc. (NASDAQ:CLSD) will report its second quarter 2021 financial results on August 10, 2021, post-market. A webcast and conference call will be held at 4:30 p.m. ET to discuss these results and provide an update on the company’s initiatives. Clearside specializes in treatments for severe eye diseases, utilizing its proprietary SCS Microinjector® to deliver therapies directly to affected areas within the eye. More information can be accessed on their website.

Clearside Biomedical (NASDAQ:CLSD) announced positive safety results from Cohort 1 of its OASIS Phase 1/2a clinical trial of CLS-AX for neovascular age-related macular degeneration (wet AMD). The 0.03 mg dose was well-tolerated, with no treatment-related adverse events. Cohort 2 patient screening for the 0.1 mg dose will begin in June 2021. The preliminary data showed that five out of six patients improved their best corrected visual acuity after receiving CLS-AX. The trial will advance to higher doses, with expected results from Cohorts 2 and 3 by year-end.

Clearside Biomedical (NASDAQ:CLSD) announced participation in two investor conferences in June 2021. George Lasezkay, CEO, and Thomas A. Ciulla, Chief Medical Officer, will host fireside chats at:

• JMP Securities Life Sciences Conference: June 16, 2021, at 1:00 pm ET
• Raymond James Human Health Innovations Conference: June 23, 2021, at 8:40 am ET

Live and archived webcasts can be found on the company's website. Clearside specializes in treatments for serious eye diseases using its proprietary SCS Microinjector technology.

Bausch Health and Clearside Biomedical announced that the FDA has accepted the resubmitted New Drug Application for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension). The PDUFA action date is set for October 30, 2021. XIPERE targets macular edema associated with uveitis, a leading cause of vision loss. If approved, it would be the first therapy utilizing the suprachoroidal space for treatment. Clearside's SCS Microinjector aims to improve drug delivery, potentially minimizing adverse effects compared to traditional methods.

Clearside Biomedical (NASDAQ:CLSD) announced its New Drug Application resubmission for XIPERE, intended for treating macular edema associated with uveitis. This would mark the company's first commercial product if approved. The company also reported a net loss of $7.4 million for Q1 2021, significantly higher than the $2.9 million loss in Q1 2020, largely due to increased R&D expenses of $5.5 million. However, cash reserves stand at $26.1 million, providing operational runway through Q1 2022. Cohort 1 data from the ongoing OASIS Phase 1/2a trial is expected in June 2021.

Clearside Biomedical (NASDAQ:CLSD) presented clinical data on its suprachoroidal injection platform at the ARVO 2021 Virtual Meeting (May 1-7). Key highlights include progress in the CLS-AX clinical program and an ongoing review of XIPERE by the FDA. Studies showed that suprachoroidal injections can enhance safety and efficacy for retinal disorders. The company emphasized the importance of their proprietary delivery systems and reported safety profiles comparable to traditional methods. The need for improved long-term therapies for retinal diseases remains a focus amid ongoing clinical trials.