DRSS

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

Retrieved on: 
Monday, February 5, 2024

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 First Patient Dosed in Phase 2 VERONA Clinical Trial of EYP-1901 for the Treatment of Diabetic Macular Edema

Retrieved on: 
Wednesday, January 10, 2024

DME is a common sight-threatening complication of diabetes that can lead to severe vision loss.

Key Points: 
  • DME is a common sight-threatening complication of diabetes that can lead to severe vision loss.
  • It represents the second diabetic eye disease indication that we are evaluating for potential treatment using EYP-1901,” said Jay Duker, M.D., Chief Executive Officer of EyePoint Pharmaceuticals.
  • The three-arm trial is expected to enroll approximately 25 patients assigned to one of two intravitreal doses of EYP-1901 or an aflibercept control.
  • The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria.

OcuTerra Therapeutics Announces Last Patient Completes Final Visit in Nesvategrast (OTT166) Eye Drop Phase 2 DR:EAM Clinical Trial in Diabetic Retinopathy

Retrieved on: 
Wednesday, January 3, 2024

Nesvategrast, OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop, is being developed as a possible treatment for the millions of patients with diabetic retinopathy who currently have no active, non-invasive therapies approved for this potentially devastating disease.

Key Points: 
  • Nesvategrast, OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop, is being developed as a possible treatment for the millions of patients with diabetic retinopathy who currently have no active, non-invasive therapies approved for this potentially devastating disease.
  • These data will show the percentage of patients that have a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) when treated with nesvategrast vs. placebo.
  • The 24-week study enrolled 225 adult patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.
  • We are excited to begin planning the next phase of development for nesvategrast.”

Ocuphire Pharma Announces Successful End-of-Phase 2 Meeting with FDA for Oral APX3330 in Diabetic Retinopathy

Retrieved on: 
Thursday, November 2, 2023

FARMINGTON HILLS, Mich., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of oral APX3330 for the treatment of diabetic retinopathy (DR) into Phase 3 studies based on the recently completed Phase 2 ZETA-1 trial.

Key Points: 
  • “We are pleased to have FDA agreement on the primary endpoint for Phase 3 pivotal trials of APX3330 which we believe is the most advanced oral therapy currently in development for diabetic retinopathy,” said George Magrath, M.D, MBA., M.S., Chief Executive Officer of Ocuphire.
  • “Results from our Phase 2 ZETA-1 results demonstrate that oral APX3330 has the potential to slow or prevent clinically meaningful progression of diabetic retinopathy, as measured by the percentage of subjects with ≥ 3-step worsening on a binocular diabetic retinopathy severity scale (DRSS), which will be the Phase 3 primary endpoint.
  • The randomized, double-masked, placebo-controlled Phase 2 trial was designed to evaluate the efficacy and safety of oral APX3330 in diabetic retinopathy patients.
  • A safe convenient oral medication that could slow or prevent diabetic retinopathy would be a major advance in our fight against diabetic blindness.”

Ocuphire Pharma to Present at Euretina and Retina Society Conferences in October

Retrieved on: 
Friday, October 6, 2023

FARMINGTON HILLS, Mich., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced presentations featuring results from the ZETA-1 Phase 2 Trial of APX3330 at the 23 rd Euretina Congress to take place October 5-8, 2023 in Amsterdam, Netherlands and at the 56th Annual Retina Society Scientific Meeting to take place October 11-14, 2023 in New York, NY.

Key Points: 
  • FARMINGTON HILLS, Mich., Oct. 06, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced presentations featuring results from the ZETA-1 Phase 2 Trial of APX3330 at the 23 rd Euretina Congress to take place October 5-8, 2023 in Amsterdam, Netherlands and at the 56th Annual Retina Society Scientific Meeting to take place October 11-14, 2023 in New York, NY.
  • Oral APX3330 Reduces the DRSS Worsening After 24-weeks of Daily Treatment: Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy

EyePoint Pharmaceuticals Reports Positive Masked Safety Update for Lead Product Candidate EYP-1901 in Ongoing PAVIA and DAVIO 2 Phase 2 Clinical Trials as of September 1, 2023

Retrieved on: 
Monday, September 11, 2023

WATERTOWN, Mass., Sept. 11, 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 positive interim masked safety data for its lead product candidate EYP-1901 from the Company’s ongoing Phase 2 PAVIA trial evaluating EYP-1901 as a potential nine-month treatment for moderately-severe to severe non-proliferative diabetic retinopathy (NPDR) and DAVIO 2 trial as a potential six-month sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD). All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of September 1, 2023.

Key Points: 
  • All treatment arms in the PAVIA trial have reached at least 3-months post-dosing follow-up as of September 1, 2023.
  • “We remain very encouraged by the positive masked safety results that EYP-1901 has produced to-date in the 17 patients dosed in the Phase 1 DAVIO trial in wet AMD as well as approximately 150 additional patients in our two Phase 2 clinical trials: DAVIO 2 and PAVIA.
  • Secondary endpoints include reduction in vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety.
  • DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with previously treated wet AMD.

Ocuphire Pharma to Present at ESCRS 2023 and MODLive! Conferences in September

Retrieved on: 
Thursday, September 7, 2023

FARMINGTON HILLS, Mich., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that it will present clinical data on APX3330 and Nyxol® at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) to take place September 8th - 11th, in Vienna, Austria.

Key Points: 
  • FARMINGTON HILLS, Mich., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that it will present clinical data on APX3330 and Nyxol® at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) to take place September 8th - 11th, in Vienna, Austria.
  • In addition, Bindu Manne, Head of Market Development and Commercialization at Ocuphire, will deliver a corporate presentation at the MODLive!
  • Conference to take place September 8th - 10th, in Nashville, TN.
  • Oral APX3330 Reduces the DRSS Worsening After 24-Weeks of Daily Treatment: Efficacy And Safety Results Of the Zeta-1 Phase 2 Trial in Diabetic Retinopathy

Abstract on ZETA-1 Study of APX3330 Receives Award at Women in Ophthalmology (WIO) Summer Symposium

Retrieved on: 
Monday, August 28, 2023

The presentation “ZETA-1 Phase 2 Trial Safety and Tolerability Results for APX3330: A Novel, Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy” was delivered by Priya Vakharia M.D., vitreo-retina specialist at Retina Vitreous Associates of Florida.

Key Points: 
  • The presentation “ZETA-1 Phase 2 Trial Safety and Tolerability Results for APX3330: A Novel, Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy” was delivered by Priya Vakharia M.D., vitreo-retina specialist at Retina Vitreous Associates of Florida.
  • The abstract received the Joanne Angle Abstract of Distinction Award out of nearly 600 submissions.
  • “I am honored to receive the prestigious Joanne Angle Abstract of Distinction award from WIO for this abstract on ZETA-1 data, and to have the opportunity to share these important data with my fellow ophthalmologists,” said Priya Vakharia M.D.
  • If approved, APX3330 can allow us to intervene early in the disease and prevent vision-threatening complications.”
    Rick Rodgers, Interim CEO of Ocuphire added.

Ocuphire Pharma Announces Financial Results for Second Quarter 2023 and Provides Corporate Update

Retrieved on: 
Friday, August 11, 2023

FARMINGTON HILLS, Mich., Aug. 11, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • FDA approval in RM would trigger a $10 million milestone payment to Ocuphire
    In July 2023, Ocuphire confirmed an End-of-Phase 2 meeting with the FDA, scheduled for the fourth quarter of 2023.
  • On August 10, 2023, Ocuphire entered into a common share purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (LPC), an institutional investor.
  • Second Quarter ended June 30, 2023 Financial Highlights
    As of June 30, 2023, Ocuphire had cash and cash equivalents of approximately $40.0 million.
  • For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 to be filed with the Securities and Exchange Commission.

OcuTerra Completes Enrollment in Phase 2 DR:EAM Clinical Trial of Topically Delivered OTT166 in Adults with Diabetic Retinopathy

Retrieved on: 
Tuesday, July 18, 2023

“With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a non-invasive, earlier intervention.

Key Points: 
  • “With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a non-invasive, earlier intervention.
  • The trial enrolled 225 adult patients who were randomly assigned one of two doses of OTT166 or to one of two control groups receiving vehicle.
  • OTT166 is a small molecule RGD integrin inhibitor delivered topically in the form of an eye drop and is purpose-engineered to distribute to the retina in therapeutic concentrations.
  • “This is an essential milestone for the development of a treatment that could benefit millions of patients with DR.”