Anti-VEGF

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

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 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

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

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.

Adverum Biotechnologies Reports Third Quarter 2023 Financial Results and Pipeline Highlights

Retrieved on: 
Thursday, November 9, 2023

REDWOOD CITY, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • “In our OPTIC presentation at AAO, we’ve built upon our industry leading dataset in wet AMD gene therapy,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • Scientific Meeting Presentations: In October 2023, Adverum showcased non-clinical data in two presentations at the European Society of Cell and Gene Therapy 2023 Annual Meeting.
  • Stock-based compensation expense included in research and development expenses was $1.2 million for the third quarter of 2023.
  • Stock-based compensation expense included in general and administrative expenses was $3.2 million for the third quarter of 2023.

RIBOMIC Phase I and II Data Published in the Eye: Full TOFU/RAMEN/TEMPURA Trial Results Demonstrate Clinical Proof of Concept of Umedaptanib Pegol in Exudative Age-Related Macular Degeneration (nAMD)

Retrieved on: 
Tuesday, December 5, 2023

TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib pegol in five treatment-naïve nAMD patients.

Key Points: 
  • TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib pegol in five treatment-naïve nAMD patients.
  • Throughout these studies umedaptanib pegol was safe, well tolerated, and effective to treat nAMD patients with no or short history of anti-VEGF treatment.
  • In nAMD patients with a long history of anti-VEGF treatment, umedaptanib pegol showed no additional benefit of monotherapy or the combination over Eylea®.
  • Notably, visual acuity decreased slightly in patients who switched from anti-VEGF (Eylea®) to umedaptanib pegol in the RAMEN study.

FRUZAQLA™ (fruquintinib) Now Available from Onco360 for the Treatment of Adult Patients with Metastatic Colorectal Cancer (mCRC)

Retrieved on: 
Tuesday, November 21, 2023

Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.

Key Points: 
  • Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.
  • Colorectal cancer is the fourth most frequent diagnosed cancer and second leading cause of death in the U.S.
  • Fruquintinib vs Placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicenter, randomized double blind, phase 3 study.
  • Effect of fruquintinib vs Placebo on overall survival in patients with previously treated metastatic colorectal cancer.

HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Thursday, November 9, 2023

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that its partner Takeda received approval from the U.S. Food and Drug Administration (“FDA”) for FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (“VEGF”) therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.1,2 This approval was received under Priority Review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30, 2023.

Key Points: 
  • The FDA approval of FRUZAQLA triggers a US$35 million milestone payment from Takeda.
  • Fruquintinib is developed and marketed in China by HUTCHMED following approval in September 2018, under the brand name ELUNATE™, in partnership with Eli Lilly and Company.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023 .

Adverum Biotechnologies Announces 3-Year Efficacy and Safety Results from the OPTIC Extension Study in Patients with Wet AMD at AAO 2023

Retrieved on: 
Saturday, November 4, 2023

A summary of previously announced aflibercept protein levels from the LUNA study was also presented.

Key Points: 
  • A summary of previously announced aflibercept protein levels from the LUNA study was also presented.
  • “These efforts are now supported by the most mature dataset in wet AMD IVT gene therapy, with the OPTIC safety and efficacy data now sustained out to 3 years.
  • We are particularly encouraged by the continuous and consistent aflibercept protein levels observed at up to 4.5 years post-treatment.
  • Taken together, the efficacy and safety at the 2E11 dose in the OPTIC trial underscore Ixo-vec's potential as a promising treatment option for wet AMD patients addressing real-world unmet needs.

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

Retrieved on: 
Wednesday, November 1, 2023

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.

RetinalGeniX IRB Approved to Conduct Study to Personalize Medical Evaluations for Patients Receiving Treatment for Wet Macular Degeneration

Retrieved on: 
Monday, October 30, 2023

The study aims to offer recommendations for enhancing the preselection process and management of ocular injections.

Key Points: 
  • The study aims to offer recommendations for enhancing the preselection process and management of ocular injections.
  • The proposed patient selection process has the potential to reduce the cost and improve the safety and efficacy of patient candidate selection for ocular injections.
  • “RetinalGeniX DNA/GPS has submitted a study with Pearl IRB to perform a clinical review of 390 patients.
  • Jerry Katzman, MD, the CEO of RetinalGeniX, emphasized the importance of limiting ocular anti-VEGF injections into patients’ eyes for those who are good candidates for responsive treatment.