WET AMD


Associated tags: Paratriathlon, Injection, VEGF, AMD, Patient, Pharmaceutical industry, FDA, Clinical trial, PRISM, Diabetic retinopathy, CST, Angiogenesis, DME, Conference, Anti-VEGF, Safety, Food

Locations: UNITED STATES

Ocular Therapeutix™ Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

Retrieved on: 
Tuesday, February 13, 2024
Injection, FDA, Consultant, Eye, Diabetic retinopathy, Macular degeneration, AMD, Patient, SPA, Clinical trial, Axitinib, SOL, Research, Pharmaceutical industry

The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.

Key Points: 
  • The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.
  • “The screening of these subjects in the pivotal Phase 3 SOL-1 trial of AXPAXLI marks an exciting milestone for Ocular Therapeutix,” said Antony Mattessich, CEO of Ocular Therapeutix.
  • We believe that AXPAXLI could set a new standard in wet AMD therapy by significantly extending time between treatments.
  • “Clinical trials like the SOL-1 study for AXPAXLI represent a critical step forward in our pursuit of more patient-centric treatments for wet AMD.

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."

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 .

Ocular Therapeutix™ Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

Retrieved on: 
Thursday, January 25, 2024
Eye, Injection, SOL, Axitinib, Food, AMD, SPA, FDA, Clinical trial, Visual acuity, Pharmaceutical industry

BEDFORD, Mass., Jan. 25, 2024 (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 that the U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal Phase 3 SOL clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).

Key Points: 
  • The SPA Agreement Modification enables the trial to include treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.
  • The SPA Agreement Modification also allows the pivotal trial to move forward, evaluating AXPAXLI with a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib.
  • “With the changes reflected in the SPA Agreement Modification agreed to by the FDA, we believe we can accelerate the enrollment process for the SOL trial,” said Antony Mattessich, CEO of Ocular Therapeutix.
  • “We have worked closely with the FDA to ensure that the SOL trial meets the agency’s updated guidance for wet AMD clinical trials, and we are eager to advance our engagement with clinical sites to enroll this trial under these new criteria."

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.

4DMT to Present Interim 24 Week Data from Randomized Phase 2 PRISM Clinical Trial of 4D-150 in High Treatment Need Wet AMD Patients at Angiogenesis, Exudation, and Degeneration 2024 Conference

Retrieved on: 
Monday, December 4, 2023
Conference, AMD, Clinical trial, Medicine, University, M.A, AAV, University of Nevada, Reno, PRISM, Patient, Angiogenesis, Clinical research, Science

Initial interim landmark data analysis (N=50 at 24 Weeks) to be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, on Saturday, February 3, 2024 at 4:20 p.m.

Key Points: 
  • Initial interim landmark data analysis (N=50 at 24 Weeks) to be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, on Saturday, February 3, 2024 at 4:20 p.m.
  • ET
    EMERYVILLE, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that the initial interim landmark data analysis (24 weeks) from the randomized Dose Expansion stage (N=50) of the Phase 2 PRISM clinical trial in high anti-VEGF (vascular endothelial growth factor) treatment need (6-12 anti-VEGF injections in prior 12 months) wet AMD patients will be presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference being held virtually on February 3, 2024.
  • The Company will also host a webcast to discuss the data in detail and include a 4D-150 program update with details to be announced at a future date.
  • Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at University of Nevada, Reno School of Medicine
    The presentation from the Angiogenesis, Exudation, and Degeneration 2024 Conference will also be available on the 4D Molecular Therapeutics website under Scientific Presentations:

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

Retrieved on: 
Wednesday, November 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.

4DMT Receives EMA Priority Medicines (PRIME) Designation for 4D-150 Clinical-Stage Genetic Medicine for Treatment of Wet AMD

Retrieved on: 
Monday, October 23, 2023
FDA, VEGF, CST, AAV, Intravitreal injection, PRISM, AMD, DME, European Medicines Agency, SAE, Diabetic retinopathy, EMA, Safety, Intraocular pressure, Patient, Anti-VEGF, Vaccine, Pharmaceutical industry, Placental growth factor

PRIME designation is granted by the EMA to enhance support for the development of medicines that target an unmet medical need and offers the opportunity to accelerate review of the marketing applications to bring such medicines to patients sooner.

Key Points: 
  • PRIME designation is granted by the EMA to enhance support for the development of medicines that target an unmet medical need and offers the opportunity to accelerate review of the marketing applications to bring such medicines to patients sooner.
  • The designation follows positive interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile.
  • “We are thrilled that the EMA has awarded PRIME designation to intravitreal 4D-150,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • We are efficiently advancing 4D-150 development for treatment of both wet AMD and DME patients, both of which represent large market opportunities.