Axitinib

Clearside Biomedical’s Versatile Suprachoroidal Injection Platform Highlighted in Four Ophthalmic Indications in Clinical Data Presentations at AAO 2023 Annual Meeting

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星期二, 十一月 7, 2023
TKI, Neoplasm, Patient, SCS, FDA, Cohort, Axitinib, I Am the Moon, AMD, AAO, Safety, Inflammation, Melanoma, Diabetic retinopathy, HIV disease progression rates, Pharming, OASIS, American Academy, Retina, Paratriathlon, Annual general meeting, Clearside, Eye, Suprachoroidal drug delivery, Visual acuity, Oxygen toxicity, Pharmaceutical industry

“The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.

Key Points: 
  • “The AAO meeting held over the past week was exceptionally positive for Clearside and our clinical development partners,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.
  • Two of our partners, REGENXBIO and Aura Biosciences, presented new, positive Phase 2 safety and clinical efficacy data from their respective programs utilizing our SCS Microinjector.
  • The findings from the survey indicated that physicians found the XIPERE injection easy to learn, with patient outcomes consistent with clinical trial data.
  • Clearside’s medical meeting presentations can be accessed on the Company’s Publications and Presentations page.

Ocular Therapeutix™ Provides Third Quarter 2023 Financial Results and Corporate Update

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星期二, 十一月 7, 2023
FDA, Research, Growth, ASC, Axitinib, ASCRS, Food, Intraocular pressure, SOL, Medicare, Eye, Telecanthus, Abdominal ultrasonography, OHT, AMD, OAG, Overalls, CPT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Inflammation, Patient, OPPS, Interest, Allergic conjunctivitis, Clinical trial, Marketing, Webcast, Barings LLC, Macular degeneration, Depreciation, Safety, SPA, Visual acuity, Trial of the century, Pain, Centers for Medicare & Medicaid Services, CMS, Pharmaceutical industry, Beauty salon, Fine chemical, Medical device, Birth control, Video game

BEDFORD, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported financial results for the third quarter ended September 30, 2023, and provided updates on its ophthalmology pipeline.

Key Points: 
  • “We made significant progress at Ocular Therapeutix in the third quarter,” said Antony Mattessich, President and CEO.
  • The Company also recorded gains and losses from debt extinguishment, net, of $14.2 million in the third quarter of 2023.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $5.4 million in the third quarter of 2023 versus $4.7 million for the comparable quarter in 2022.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update.

Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD

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星期三, 十一月 1, 2023
Eye, AMD, FDA, SPA, Axitinib, Patient, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SOL, Pharmaceutical industry

BEDFORD, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) --  Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced it had received written agreement regarding the overall design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (wet AMD), which the Company refers to as the SOL trial.

Key Points: 
  • BEDFORD, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) --  Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced it had received written agreement regarding the overall design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant), for the treatment of wet age-related macular degeneration (wet AMD), which the Company refers to as the SOL trial.
  • The Company initiated the SOL trial in September 2023 and expects to enroll approximately 300 evaluable wet AMD subjects who are treatment naïve in the study eye in the trial.
  • The SOL trial is designed to be a multi-center, parallel-group trial run primarily at U.S. sites, with subjects randomized to one injection of aflibercept or one implant of AXPAXLI followed by supplemental anti-VEGF treatment based on pre-specified criteria.
  • With the agreement under the SPA, the Company will begin enrolling patients in the SOL trial and expects to dose the first subject by year-end.

EyePoint Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Developments

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星期三, 十一月 1, 2023
American Academy of Ophthalmology, Șaeș, Sale, Axitinib, Therapy, AMD, TIE, ASRS, DME, AAO, Diabetic retinopathy, R, Society, Senior, Clinical trial, American Academy, Marketing, Webcast, Executive, Annual general meeting, Safety, Macular edema, Patient, Visual acuity, Investment, Retina, Anti-VEGF, Pharmaceutical industry, Management, Medical device, Video game, Ophthalmology

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with retinal diseases, today announced financial results for the third quarter ended September 30, 2023, and highlighted recent corporate developments.

Key Points: 
  • ET –
    WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with retinal diseases, today announced financial results for the third quarter ended September 30, 2023, and highlighted recent corporate developments.
  • Review of Results for the Third Quarter Ended September 30, 2023
    For the third quarter ended September 30, 2023, total net revenue was $15.2 million compared to $10.0 million for the quarter ended September 30, 2022.
  • Operating expenses for the third quarter ended September 30, 2023 totaled $29.6 million versus $28.4 million in the prior year period.
  • ET to discuss the results for the third quarter ended September 30, 2023 and recent corporate developments.

Clearside Biomedical Completes Recruitment in ODYSSEY Phase 2b Clinical Trial of CLS-AX in Wet AMD

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星期三, 十一月 1, 2023
Axitinib, CLS, AMD, Injection, Pharming, OASIS, Disease, Paratriathlon, Clinical trial, Clearside, Eye, Safety, Patient, Pharmaceutical industry

ALPHARETTA, Ga., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the completion of recruitment in its ODYSSEY Phase 2b clinical trial, a randomized, double-masked, parallel-group, active-controlled, multi-center study in participants with neovascular age-related macular degeneration (wet AMD). ODYSSEY is evaluating the safety and efficacy of CLS-AX (axitinib injectable suspension), a highly potent tyrosine kinase inhibitor delivered directly to the site of disease via Clearside’s SCS Microinjector®.

Key Points: 
  • ALPHARETTA, Ga., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the completion of recruitment in its ODYSSEY Phase 2b clinical trial, a randomized, double-masked, parallel-group, active-controlled, multi-center study in participants with neovascular age-related macular degeneration (wet AMD).
  • ODYSSEY is evaluating the safety and efficacy of CLS-AX (axitinib injectable suspension), a highly potent tyrosine kinase inhibitor delivered directly to the site of disease via Clearside’s SCS Microinjector®.
  • Following the completion of recruitment, final participants will be randomized to the CLS-AX treatment arm or the aflibercept comparator arm by the middle of December 2023.
  • “The efficacy and safety results from the study will guide the path forward for our pivotal Phase 3 development program for CLS-AX.

Junshi Biosciences Presents 11 Clinical Trials of Toripalimab at the ESMO Congress 2023

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星期五, 十月 27, 2023
Junshi, Shanghai Jiao Tong University School of Medicine, SSE, Kidney cancer, Cervical cancer, Trial of the century, Manuscript, Axitinib, ESMO, III, Renal cell carcinoma, Lung cancer, Colorectal cancer, Head, Congress, PFS, Renji Hospital, Carcinoma, Impact, Thymus, Research, HIV disease progression rates, RCC, Development, Apoptosis, Clinical trial, Risk, Breast cancer, Immunotherapy, ORR, European Society for Medical Oncology, Patient, Hospital, Death, IRC, Lymphoma, Pharmaceutical industry

At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.

Key Points: 
  • At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters.
  • “This year’s ESMO Congress highlighted the most recent results from 11 clinical studies conducted with our core product, toripalimab,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences.
  • Study findings were unveiled for the first time during a proffered paper session at the ESMO Congress.
  • In terms of safety, toripalimab combined with chemotherapy has a manageable safety profile and no new safety signals were identified.

Clearside Biomedical Positive OASIS and Extension Study Data Presented at The Retina Society 56th Annual Scientific Meeting

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星期一, 十月 16, 2023
CLS, CST, Eye, Inflammation, MD, Aes, Toxicity, Axitinib, SCS, Disease, Gene therapy of the human retina, NAMD, AMD, Diabetic retinopathy, Clinical trial, Persistent, Pharming, Patient, Retina, Visual acuity, Injection, Observation, Șaeș, TKI, Pharmaceutical industry

ALPHARETTA, Ga., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that key data from the Phase 1/2a OASIS clinical trial were presented at The Retina Society 56th Annual Scientific Meeting. The results of the trial demonstrate the key benefits of Clearside’s patented suprachoroidal delivery platform and its lead drug candidate, CLS-AX (axitinib injectable suspension) being developed for the treatment of neovascular age-related macular degeneration (wet AMD or nAMD).

Key Points: 
  • ALPHARETTA, Ga., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that key data from the Phase 1/2a OASIS clinical trial were presented at The Retina Society 56th Annual Scientific Meeting.
  • Based on the data from OASIS, CLS-AX is currently being investigated in a Phase 2b clinical trial entitled ODYSSEY.
  • “Our trial is enrolling as planned and we expect data from ODYSSEY in the third quarter of 2024.
  • In the OASIS and Extension Study, participants with wet AMD who were sub-responders with active disease at screening were followed for up to 6 months after CLS-AX treatment.

Ocular Therapeutix™ Announces Initiation of its First Pivotal Clinical Trial of OTX-TKI in Wet AMD

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星期二, 十月 3, 2023
Retina, Injection, RCA, Abstract, Ranibizumab, Clinical trial, AMD, Anatomy, Eye, Research, IRB, Patient, Associate, Clinical research, SPA, FACS, Diabetic retinopathy, Paratriathlon, Axitinib, FDA, Visual acuity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Summit, Food, Safety, Pharmaceutical industry, Medical device, MD

"We are thrilled to announce the initiation of our pivotal trial evaluating OTX-TKI for the treatment of wet AMD and look forward to working with clinical sites across the US," said Antony Mattessich, CEO of Ocular Therapeutix.

Key Points: 
  • "We are thrilled to announce the initiation of our pivotal trial evaluating OTX-TKI for the treatment of wet AMD and look forward to working with clinical sites across the US," said Antony Mattessich, CEO of Ocular Therapeutix.
  • He has served as a principal investigator for numerous clinical trials evaluating novel treatments for wet AMD and other retinal diseases.
  • The OTX-TKI pivotal trial design is unique as it is based on the latest FDA guidance for wet AMD.
  • “This pivotal trial is thoughtfully designed to satisfy the FDA’s latest guidance in wet AMD, while also balancing the needs of subjects who enter it,” said Dr. Brown.

Clearside Biomedical Announces Second Quarter 2023 Financial Results and Provides Corporate Update

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星期一, 八月 14, 2023
Pharming, Safety, New Drug Application, General partnership, TKI, Experiment, Patient, Research and development, R, Axitinib, SCS, SAB, ARVO, Retinal pigment epithelium, Therapy, ISO, Experimental & Molecular Medicine, Research, Genome, Choi, International Organization for Standardization, Conference call, Partner, The Association, Conference, ASRS, Retina, Eye, Administration, Chairperson, Certification, Webcast, International Organization (journal), OASIS, Association for Research in Vision and Ophthalmology, AMD, NDA, Needle, ET, Physician, Annual general meeting, Visual acuity, Society, Pharmaceutical industry, Medical device, Video game, Clearside, Ophthalmology, MD

ALPHARETTA, Ga., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.
  • License Revenue: License and other revenue for the second quarter of 2023 was $1.0 million, compared to $0.4 million for the second quarter of 2022.
  • Other Income: Other income for the second quarter of 2023 was $0.5 million, compared to $24,000 for the second quarter of 2022.
  • Other Expense: Non-cash interest expense for the second quarter of 2023 was $2.3 million, compared to $0 in the second quarter of 2022.

Ocular Therapeutix™ Provides Second Quarter 2023 Financial Results and Corporate Update

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星期一, 八月 7, 2023
OAG, ASC, Clinical trial, Marketing, AMD, Trial of the century, Line of credit, Eye, SOFR, Month, Inflammation, Șaeș, Pain, Intraocular pressure, Interest, Ocular hypertension, Patient, Allergic conjunctivitis, Ophthalmology, Barings LLC, Growth, Webcast, OHT, Depreciation, Abdominal ultrasonography, Research, Axitinib, FDA, Summit, Treatment, Safety, Beauty salon, Pharmaceutical industry, Telescopic sight, Video game, Birth control, Arms industry

“The progress at Ocular Therapeutix over this last quarter has been significant,” said Antony Mattessich, President and CEO.

Key Points: 
  • “The progress at Ocular Therapeutix over this last quarter has been significant,” said Antony Mattessich, President and CEO.
  • The Company intends to initiate the first of two planned pivotal trials in wet AMD in Q3 2023.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $5.1 million in the second quarter of 2023 versus $4.8 million for the comparable quarter in 2022.
  • Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update.