Angiogenesis

EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments

Retrieved on: 
Thursday, March 7, 2024
Therapy, ARVO, Research, Investment, FDA, Food, Sale, Șaeș, Exercise, Diabetic retinopathy, Safety, Visual acuity, AMD, Patient, Drug, Clinical trial, MOA, Net, Retina, Plasma, Conditional sentence, Angiogenesis, Pharmaceutical industry

ET –

Key Points: 
  • ET –
    WATERTOWN, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and highlighted recent corporate developments.
  • “2023 was an exceptional year of execution and results for EyePoint Pharmaceuticals.
  • Review of Results for the Fourth Quarter Ended December 31, 2023
    For the quarter ended December 31, 2023, total net revenue was $14.0 million compared to $10.5 million for the quarter ended December 31, 2022.
  • ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments.

4DMT Reports Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Thursday, February 29, 2024
Therapy, Atypical hemolytic uremic syndrome, Chelsea Handler, Fabry disease, Respiratory disease, EMA, Injection, Research, CRISPR, Cystic fibrosis, FDA, Partnership, Inflammation, Retinitis pigmentosa, Security (finance), Overalls, Biopsy, Șaeș, PRISM, Conference, Cash, Diabetic retinopathy, Geographic atrophy, Astellas Pharma, CFTR, CNS, PRIME, AMD, Choroideremia, Patient, Safety, Clinical trial, Angiogenesis, VG, DME, AAV, Vaccine

We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.

Key Points: 
  • We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.
  • R&D Expenses: Research and development expenses were $97.1 million for 2023, as compared to $80.3 million for 2022.
  • G&A Expenses: General and administrative expenses were $36.5 million for 2023, as compared to $32.9 million for 2022.
  • Net Loss: Net loss was $100.8 million for 2023, as compared to net loss of $107.5 million for 2022.

Ocuphire Pharma Announces Presentation on APX3330 at the Annual Angiogenesis, Exudation, and Degeneration 2024 Conference

Retrieved on: 
Monday, February 5, 2024
PDR, Conference, DRSS, Diabetes, Patient, FDA, Retina, Physician, Week, Diabetic retinopathy, Binocular, Angiogenesis, University, OCUP, Champaign–Urbana metropolitan area, Pharmaceutical industry

Dr. Sheth reviewed the current treatment paradigm for diabetic retinopathy.

Key Points: 
  • Dr. Sheth reviewed the current treatment paradigm for diabetic retinopathy.
  • The majority of patients who are diagnosed have non-proliferative diabetic retinopathy (NPDR), but there is a high likelihood of progression to proliferative diabetic retinopathy (PDR) over time.
  • APX3330 showed favorable safety and tolerability in diabetic patients that continued dosing their medications through the study durations to manage their diabetic comorbidities.
  • We look forward to advancing our oral APX3330 program.”

EyePoint Pharmaceuticals Announces Two Presentations of Topline Data with Additional Subgroup Analyses from the Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Treatment of Wet Age-Related Macular Degeneration

Retrieved on: 
Saturday, February 3, 2024
Injection, Thomas Jefferson University, FACS, Clinical trial, AMD, Therapy, Consultant, Patient, Safety, OCT, Diagnosis, FDA, Șaeș, Anti-VEGF, Visual acuity, Retina, Food, Angiogenesis, CST, Pharmaceutical industry

This result confirms that the positive visual and anatomical outcomes from our Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.

Key Points: 
  • This result confirms that the positive visual and anatomical outcomes from our Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.
  • A second presentation also included the previously reported positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901.
  • DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD.
  • Phase 2 DAVIO 2 12-month results and the initiation of a Phase 3 trial in wet AMD are both expected in the second half of 2024.

4DMT Presents Positive Interim Data from Randomized Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD

Retrieved on: 
Saturday, February 3, 2024
Injection, Paratriathlon, Conference, Inflammation, Aflibercept, Data, Clinical trial, AMD, Patient, Conditional sentence, OCT, PRISM, FDA, EMA, Retina, Visual acuity, Arm, DME, Angiogenesis, M.A, Webcast, CST, Pharmaceutical industry

Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.

Key Points: 
  • Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.
  • "I am encouraged by the potential of a one-time intravitreal injection of 4D-150 for treating wet AMD.
  • Results from the Phase 1 and interim results from Phase 2 cohorts of the PRISM study confirm that 4D-150 is well tolerated and maintains stable visual acuity in previously treated high-need patients.
  • I believe 4D-150 has the potential to revolutionize the treatment approach for our patients with wet AMD, and I am looking forward to participating in the Phase 3 trials."

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Paratriathlon, Inflammation, Ranibizumab, Research, Ophthalmology, RVO, Patient, Diabetic retinopathy, Swelling, CRVO, BRVO, Food, ROG, Bascom Palmer Eye Institute, Retina, Blood, Macular edema, Angiogenesis, Roche, Eye, CST, Telescopic sight

In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

Key Points: 
  • In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.
  • Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
  • In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
  • “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis.

Kodiak Sciences Announces Upcoming Presentation of First Time Results of KSI-501ABC Phase 1 Study at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting

Retrieved on: 
Tuesday, January 30, 2024
Senior, Angiogenesis, Patient, PALO, ABC, Clinical research, University, Outline, Partner (business rank), Safety, Disease, Diabetic retinopathy, Therapy, Inflammation, KOD, Retina, Multiple, DME, Vaccine

PALO ALTO, Calif., Jan. 30, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that first time results of the KSI-501ABC Phase 1 Study will be presented at the Angiogenesis, Exudation, and Degeneration 2024 virtual meeting.

Key Points: 
  • PALO ALTO, Calif., Jan. 30, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that first time results of the KSI-501ABC Phase 1 Study will be presented at the Angiogenesis, Exudation, and Degeneration 2024 virtual meeting.
  • KSI-501ABC is the second product candidate built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform.
  • "We look forward to sharing for the first time the results of our Phase 1 study of KSI-501ABC, our anti-IL-6 antibody and VEGF-trap bispecific therapeutic candidate in its antibody biopolymer conjugate form.
  • We believe these early results support further clinical development of the KSI-501 program," said Dr. J. Pablo Velazquez-Martin, MD., Senior Vice President of Clinical Research and Development.

4DMT to Host Corporate Webcast to Discuss Interim Data from Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 in Wet AMD Patients with Severe Disease Activity & High Treatment Burden

Retrieved on: 
Monday, January 29, 2024
PRISM, Angiogenesis, Patient, Science, Clinical research, University, Medicine, M.A, Conference, AMD, Webcast, University of Nevada, Reno, Clinical trial, Pharmaceutical industry

Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m.

Key Points: 
  • Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m.
  • ET)
    Company to host webcast on Monday, February 5, 2024 at 8:00 a.m.
  • Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, will also present in the webcast and be available for Q&A.
  • An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website at the following link: https://ir.4dmoleculartherapeutics.com/events .

4DMT Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD

Retrieved on: 
Thursday, December 21, 2023
Conference, Food, Drug development, PRIME, EMA, FDA, Intraocular pressure, AMD, Regenerative medicine, Diabetic retinopathy, Anti-VEGF, SAE, CST, Ophthalmology, PRISM, Patient, Safety, Angiogenesis, Pharmaceutical industry

The FDA granted RMAT designation based on the potential of 4D-150 to address the unmet medical need within this population.

Key Points: 
  • The FDA granted RMAT designation based on the potential of 4D-150 to address the unmet medical need within this population.
  • The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition.
  • The designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile.
  • “We are honored to receive the first ever RMAT designation for an investigational treatment for wet AMD with our intravitreal 4D-150 genetic medicine,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints

Retrieved on: 
Monday, December 4, 2023
Conference, Food, Eye, Șaeș, DME, FDA, Retina, Type, Data, AMD, Injection, Diabetic retinopathy, OCT, Anti-VEGF, Conference call, Clinical trial, CST, Visual acuity, Patient, Safety, Angiogenesis, Therapy, Kinetics, Pharmaceutical industry

Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).

Key Points: 
  • Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).
  • “We are incredibly pleased by these highly positive Phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile.
  • The 32-week topline DAVIO 2 data strongly supports our planned Phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials.
  • “I want to congratulate the EyePoint team on the continued execution of this program.”
    DAVIO 2 topline interim results include:
    Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints.