|Over a week ago|
Clearside Biomedical abstracts highlight strength, says Roth Capital » 09:3406/1906/19/20
Clearside Biomedical's multiple abstracts at the ARVO 2020 meeting highlight the company's strengths, Roth Capital analyst Zegbeh Jallah tells investors in a research note. They include studies outlining the current treatment burden for indications Clearside intends to pursue, preclinical studies for its potential pipeline and pipeline products including CLS-AX, as well as data reaffirming the "differentiated benefits" of the company's suprachoroidal-space microinjector and the predictive benefits of these early preclinical studies, says the analyst. Jallah keeps a Buy rating on Clearside with an $8 price target.
Clearside Biomedical announce presentations at ARVO 2020 meeting » 07:1606/1706/17/20
Title: Suprachoroidal Delivery with the SCS Microinjector: Characterization of Operational Forces. Conclusions: Forces to operate the SCS Microinjector using a variety of injectates are far below the international standard recommendations for low-volume hypodermic syringe operation. This may improve the usability of the SCS Microinjector by minimizing resistance forces inherent to the device, therefore allowing the user more accurate tactile feedback with loss of resistance when the suprachoroidal space is reached. Title Retrospective Correlation Analysis of Suprachoroidal Injection Experience and Refraction. Conclusions: While these analyses with a 900 microm needle compared to a 1100 microm needle are retrospective with a relatively small sample size, refraction appeared to have little correlation with the needle length used for suprachoroidal injections. This is supported by the literature that scleral thinning with myopia is more prominent along the anterior-posterior axis than around the circumference near the pars plana, where suprachoroidal injections are administered. Taken together, this indicates that suprachoroidal injections with the SCS Microinjector have the potential to reliably and repeatably deliver drugs for chorio-retinal diseases among a wide span of refractive values. Title: Post hoc Analysis of Clinical Suprachoroidal Injection Experience Across Indications. Conclusions: To date, this is the largest aggregate dataset of suprachoroidal clinical injections with mounting evidence pointing to the reliability and consistency of the procedure. Despite the retrospective nature of the analyses, the results demonstrated the robustness of the suprachoroidal injection regardless of indications. The two needle length options successfully accommodate for anatomical variations across patients. Title: Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Noninfectious Uveitis. Conclusions: In this cohort of over 1000 eyes, there were moderate relationships between BCVA and central subfield thickness in patients with ME due to RVO, diabetic macular edema (DME) and noninfectious uveitis at baseline and these were similar across disease states. There were also moderate relationships between BCVA and CST across these disease states with respect to change from baseline to 6 months. These correlations provide context around the use of CST in clinical decision making and visual recovery. Title: Results from the Phase 3 PEACTHREE Clinical Trial: Efficacy of CLS-TA in Patients Not Taking Systemic Therapy, a Post-Hoc Analysis. Conclusions : These post hoc results corroborate the prespecified study analyses in the PEACHTREE trial. With respect to BCVA and CST, a clinically meaningful relative benefit of CLS-TA over control was noted in patients on systemic immunosuppression as well as those not on other systemic therapies. Title: Area of Disorganization of the Retinal Inner Layers as a Quantitative Biomarker in Eyes with Diabetic Macular Edema. Conclusions : The extent of DRIL appears to decrease following treatment of DME. Area of DRIL correlates better with visual function than the linear extent of DRIL, and may be a useful quantitative biomarker in future studies of diabetic macular edema.
Clearside Biomedical announce presentations at ARVO 2020 meeting » 07:1506/1706/17/20
Clearside Biomedical announced today that multiple oral presentations on Clearside's pipeline and its proprietary SCS Microinjector targeting the suprachoroidal space are available online at the ARVO 2020 Meeting. Due to COVID-19, the ARVO 2020 Annual Meeting is being held virtually. Title: Suprachoroidal CLS-AX, as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration. Conclusions: CLS-AX was well tolerated with durability in the suprachoroidal space. Results from laser choroidal neovascularization studies corroborate other studies, showing inhibition of neovascularization in animal models. Given this pharmacodynamic effect, ability to directly target affected tissues, and intrinsic highly potent pan-VEGF inhibition through receptor blockade, CLS-AX has the potential to be a long-acting therapy for nAMD. Title: Pharmacokinetics and Ocular Tolerability of Suprachoroidal CLS-AX in rabbits. Conclusions: Suprachoroidal CLS-AX provided sustained, safe and targeted delivery of axitinib to the back of the eye. Given the durability, intrinsic high potency and pan-VEGF inhibition, suprachoroidal CLS-AX has the potential to be a bi-annual therapy for nAMD. Title: Suprachoroidal Delivery of Suspensions of Tyrosine Kinase Inhibitor, Complement Inhibitor, and Corticosteroid: Preclinical and Clinical Correlates. Conclusions: Suprachoroidal delivery of suspensions of tyrosine kinase inhibitor, complement inhibitor, and corticosteroid demonstrated prolonged therapeutic levels with the potential for sustained release and high bioavailability, and showed compartmentalization with the potential to minimize adverse effects. These attributes correlate to clinical trial outcomes for corticosteroid; further study of TKI and complement factors suspensions are warranted. Title: Ocular Pharmacokinetics and Safety of Suprachoroidal A01017, Small Molecule Complement Inhibitor, Injectable Suspension in Rabbits. Conclusions: Suprachoroidal delivery of A01017 suspension, a highly potent complement factor D inhibitor that blocks alternative pathway activity, provided well tolerated, sustained high drug levels in the posterior segment in rabbits, and merits further studies in the development of long-acting small molecule complement inhibitors for dry AMD. Title: Treatment Burden and Visual Outcomes in Neovascular Age-Related Macular Degeneration. Conclusions: Despite the varying durability of the different anti-VEGF agents, there is a positive correlation between the number of injections in 12-months and the change in mean best corrected visual acuity. While challenging in practice, frequent treatment regimens have benefits in terms of vision; however, this needs to be mitigated by real-world constraints. Title: Visual Acuity Outcomes and Anti-VEGF Intensity in Macular Edema due to RVO: A "Real World" Analysis in 12,214 Eyes. Conclusions: Real-world retinal vein occlusion patients with macular edema experience worse visual outcomes compared with patients in randomized controlled trials. Mean change in visual acuity correlates with treatment intensity at 1 year. Patients with better VA at presentation tend to be particularly vulnerable to vision loss. Title: Gene Therapy Biofactory: Mathematical Modeling of Pharmacokinetics. Conclusions: The model allowed the estimation of therapeutic protein levels in the retina and vitreous, and showed an aqueous humor level-dependent increase of these levels. Future studies are needed to expand the model to account for the retina pigmented epithelium and choroid compartments that contribute to the production of the anti-VEGF protein in this biofactory approach, and whose levels are challenging to extract in the clinical setting. In the future, precision medicine aided by mathematical modeling could be employed after anterior chamber diagnostic testing of pathologic proteins, to select therapeutic options of different gene therapy biofactory approaches.
|Over a month ago|
Fly Intel: Top five analyst initiations » 10:0505/1305/13/20
WW, CGEN, CLSD, FATE, VTSI
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. WW (WW) initiated with a Buy at Jefferies. 2. Compugen (CGEN) initiated with a Buy at Stifel. 3. Clearside Biomedical (CLSD) initiated with a Buy at Roth Capital. 4. Fate Therapeutics (FATE) initiated with a Buy at H.C. Wainwright. 5. VirTra (VTSI) resumed with a Buy at Roth Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
Clearside Biomedical initiated with a Buy at Roth Capital » 05:0105/1305/13/20
Roth Capital analyst…
Roth Capital analyst Zegbeh Jallah initiated coverage of Clearside Biomedical with a Buy rating and $8 price target. The company has a patented suprachoroidal space microinjector that allows for in-office delivery of therapies, including genetic therapies, directly to the choroid and retina, Jallah tells investors in a research note. Xipere, the first drug using the microinjector, should be approved during mid-2021, says the analyst, who views Clearside's platform as undervalued.
Clearside Biomedical files $250M mixed securities shelf 17:0605/0805/08/20
Clearside Biomedical targets NDA resubmission for XIPERE in 4Q20 07:2005/0805/08/20
Clearside Biomedical expects cash to fund planned operations into 2Q21 » 07:2005/0805/08/20
As of March 31, 2020,…
As of March 31, 2020, Clearside's cash and cash equivalents totaled $20.9 million. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021.
Clearside Biomedical reports Q1 EPS (7c), consensus (11c) » 07:1905/0805/08/20
Reports Q1 revenue $4.1M,…
Reports Q1 revenue $4.1M, consensus $2M. "Our team remains focused on progressing our programs as we navigate the evolving business and regulatory environment," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We are committed to advancing our first product candidate, XIPERE, to the U.S. regulatory finish line as quickly as possible to maximize its commercial potential. Our Investigational New Drug application remains on track for submission in mid-2020 for CLS-AX in wet age-related macular degeneration, which would potentially enable us to initiate a Phase 1/2a clinical trial before the end of this year. Additionally, we continue to support our clinical development partners in gene therapy and ocular cancer as they move their programs forward using our SCS Microinjector(R)."
Clearside Biomedical expects cash to fund planned operations into 2Q21 » 07:1604/2804/28/20
As of March 31, 2020,…
As of March 31, 2020, Clearside's cash and cash equivalents totaled $20.9 million. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021. Detailed financial results for the quarter will be reported via a press release on May 8, 2020.