Macula

Adverum Biotechnologies Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Pipeline Highlights and Corporate Updates

Retrieved on: 
Monday, March 18, 2024
Research, Adverum Biotechnologies, Vasculitis, Three Months, Macula, Chorioretinitis, Inflammation, Patient, Episcleritis, American Academy, Anti-VEGF, LUNA, Intraocular pressure, Investment, Clinical trial, Injection, Safety, Drug development, Paratriathlon, AMD, AAO, OPTIC, Retinitis, CST, Vascular occlusion, Annual general meeting, VEGF, Pharmaceutical industry

REDWOOD CITY, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the fourth quarter and full year 2023. The company also provided recent pipeline highlights and corporate updates.

Key Points: 
  • The company also provided recent pipeline highlights and corporate updates.
  • 85% and 68% of patients at the 2E11 and 6E10 doses, respectively, received no supplemental injections through 26 weeks.
  • Stock-based compensation expense included in research and development expenses was $1.0 million for the fourth quarter of 2023.
  • Stock-based compensation expense included in general and administrative expenses was $3.1 million for the fourth quarter of 2023.

Oxurion Provides Update on Recruitment for KALAHARI Phase 2, Part B Trial of Novel PKal Inhibitor THR-149 in Diabetic Macular Edema and Announces Board Changes

Retrieved on: 
Tuesday, March 14, 2023
CFO, Education, Sarbanes–Oxley Act, Prevalence, Tel Aviv Sourasky Medical Center, IDMC, Month, Plasma kallikrein, System, Eye, Caregiver burden, Macula, Diabetic retinopathy, Human, University, Brussels Stock Exchange, Retina, MBA, CFA, KKS, CET, Diabetes, Part, MD, Patient, Medicare Part D, Inflammation, Tel Aviv University, CST, Safety, Injection, Optical coherence tomography, DME, Blurry, Paratriathlon, Pharmaceutical industry, Medical device, Management, Nursing, Vaccine, Ophthalmology

The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for patients with diabetic macular edema (DME) who respond suboptimally to anti-VEGF therapy, the current standard of care.

Key Points: 
  • The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for patients with diabetic macular edema (DME) who respond suboptimally to anti-VEGF therapy, the current standard of care.
  • The Phase 2 KALAHARI trial is a two-part, randomized, prospective, multi-center trial assessing multiple (3) injections of THR-149 in DME patients.
  • Part B is double-masked and actively controlled, with the high dose of THR-149 having been selected from Part A of the trial.
  • The Month 6 data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST).

Aura Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights

Retrieved on: 
Wednesday, March 15, 2023
Research, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Health, Optical, Science, Oncology, Other Science, CM, Annual general meeting, Macula, Fast track (FDA), Patient, VDC, Metastasis, Pharmaceutical industry

Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the fourth quarter and year ended December 31, 2022, and provided clinical development and operational highlights.

Key Points: 
  • Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today reported financial results for the fourth quarter and year ended December 31, 2022, and provided clinical development and operational highlights.
  • Aura is enrolling a Phase 1 clinical trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC).
  • Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.
  • In December 2022, Aura announced the closing of an oversubscribed underwritten follow-on public offering yielding aggregate gross proceeds of approximately $92.5 million.

EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2022 Financial Results and Highlights Recent Corporate Developments

Retrieved on: 
Thursday, March 2, 2023
Retinal detachment, Geographic atrophy, Clinical trial, Research, Maintenance, Macula, AMD, CMS, Aqueous humour, Treatment, Patient, Cleveland Clinic, Marketing, Cleveland, Center for Medicare and Medicaid Innovation, CALM, Investment, Webcast, Paratriathlon, G&A, Retina, Therapy, Medicare, Enrollment, Cryptocurrency, Pharmaceutical industry, Video game, Reinsurance, Medicaid

ET –

Key Points: 
  • ET –
    WATERTOWN, Mass., March 02, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced financial results for the fourth quarter and year ended December 31, 2022 and highlighted recent corporate developments.
  • Net product revenue for YUTIQ was $9.0 million in the fourth quarter of 2022 compared to $5.8 million for the fourth quarter ended December 31, 2021, a 55% increase.
  • Review of Results for the Fourth Quarter Ended December 31, 2022
    For the quarter ended December 31, 2022, total net revenue was $10.5 million compared to $11.5 million for the quarter ended December 31, 2021.
  • ET to discuss the results for the fourth quarter and year ended December 31, 2022 and recent corporate developments.

Clearside Biomedical Announces Positive Data Presentations on CLS-AX OASIS Clinical Trial and Use of SCS Microinjector® Presented at the Angiogenesis and Macula Society Annual Meetings

Retrieved on: 
Tuesday, February 21, 2023
Axitinib, Durability, TKI, University of Arizona College of Medicine – Tucson, Biomedicine, Tissue, Safety, Diabetes, AMD, Patient, Clinical trial, Eye, SCS, University of California, Irvine Medical Center, Biomedical engineering, University, Angiogenesis, Diabetic retinopathy, University of California, Irvine, Visual acuity, Macula, University of Arizona College of Pharmacy, Wallace H. Coulter Department of Biomedical Engineering, UC, Pharming, Biological effects of high-energy visible light, Phase, OASIS, Publication, Pharmaceutical industry, Medical device, Vaccine, Management, Ophthalmology

ALPHARETTA, Ga., Feb. 21, 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 several presentations were delivered at two prestigious medical conferences in February: the Angiogenesis, Exudation, and Degeneration 2023 meeting and The Macula Society 46th Annual Meeting.  

Key Points: 
  • “Our trial demonstrated that 67% of extension study participants went at least 6 months without needing additional treatment.
  • Clearside’s medical meeting presentations can be accessed on the Company’s Publications and Presentations page.
  • The results from Clearside’s OASIS Phase 1/2a clinical trial were featured.
  • The data presented showed an excellent response to the therapy with 89-100% tumor control, and a favorable safety profile to date.

Ocuphire Announces APX3330 Phase 2 Data Presentations at Retina Meetings

Retrieved on: 
Thursday, February 16, 2023
DR, Alfred Lerner College of Business and Economics, The University of Delaware, Treatment, Oral, Annual general meeting, Safety, Patient, Bascom Palmer Eye Institute, Eye, OCUP, Retina, Angiogenesis, Diabetic retinopathy, DRSS, Intravitreal injection, Macula, Cleveland Clinic, Data, FDA, Pharmaceutical industry, Ophthalmology

FARMINGTON HILLS, Mich., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced two presentations featuring efficacy and safety results from the Company’s recently completed ZETA-1 Phase 2 trial of oral APX3330 in diabetic retinopathy (DR) at two medical meetings in February. Peter Kaiser, M.D., Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and Cole Eye Institute, presented the results at the Angiogenesis, Exudation, and Degeneration 2023 Meeting held virtually on February 10-11, 2023. Rishi P. Singh, M.D., President of Cleveland Clinic Martin North and South hospitals, and Professor of Ophthalmology at the Lerner College of Medicine, will present at the upcoming Macula Society 46th Annual Meeting, to be held in-person February 15-18, 2023 in Miami, FL.

Key Points: 
  • Oral APX3330 achieved statistical significance on a key pre-specified secondary DRSS (diabetic retinopathy severity scale) endpoint of preventing clinically meaningful progression of DR after 24 weeks of treatment.
  • In addition, APX3330 demonstrated a favorable systemic and ocular safety and tolerability profile.
  • Dr. Kaiser noted, “The Phase 2 clinical trial results of the oral drug candidate APX3330 that were presented at the Angiogenesis 2023 meeting showed favorable efficacy, safety, and tolerability.
  • Intravitreal injections are currently approved for DR based on 2-step improvement in DRSS in one eye.

Aura Biosciences Announces Positive Interim Phase 2 Safety and Efficacy Data of Belzupacap Sarotalocan (Bel-sar) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma with Suprachoroidal Administration

Retrieved on: 
Thursday, February 16, 2023
Research, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Health, Optical, Science, Oncology, Other Science, Aes, Cohort, Annual general meeting, Șaeș, Safety, Radiation, Patient, I Am the Moon, SC, Ear, Visual acuity, Macula, Neoplasm, VDC, Pharmaceutical industry

The results were presented at the Macula Society 46th Annual Meeting held February 15-18, 2023, in Miami, FL.

Key Points: 
  • The results were presented at the Macula Society 46th Annual Meeting held February 15-18, 2023, in Miami, FL.
  • Cohorts 5 and 6 received up to three cycles of therapy, which was considered the therapeutic regimen for evaluation.
  • All patients from Cohort 6 (n=8) were assigned to receive three cycles of therapy at the highest dose (80 μg/dose).
  • All patients in Cohorts 5 and 6 had active growth at study entry, as an enrichment strategy to evaluate preliminary efficacy.