Intravitreal injection

Akari Therapeutics Presents Poster on Progress in Pre-Clinical Development of Long-Acting PAS-Nomacopan as a Potential Treatment for Geographic Atrophy at the 4th Annual Dry AMD Therapeutic Development Conference

Retrieved on: 
Thursday, November 16, 2023
Eye, Leukotriene B4, Intravitreal injection, Therapy, Risk, Choroidal neovascularization, CNV, Akari, Hot game, LTB4, Geographic atrophy, C5, Poster, Pharmaceutical industry

BOSTON and LONDON, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the presentation of progress in the development of long-acting PASylated®-nomacopan as a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD) in a poster at the 4th Annual Dry AMD Therapeutic Development conference.

Key Points: 
  • BOSTON and LONDON, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the presentation of progress in the development of long-acting PASylated®-nomacopan as a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD) in a poster at the 4th Annual Dry AMD Therapeutic Development conference.
  • The poster was presented by Akari Chief Scientific Officer Miles Nunn on November 15, 2023.
  • The poster can be viewed on the Akari website at akaritx.com.
  • “Part of this progress is the advancement of a high yield manufacturing process that supports our program moving into clinical trials in 2024.”
    Long-acting PAS-nomacopan is a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4).

Clearside Biomedical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

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Monday, November 13, 2023
Potential, Visual acuity, Patient, Research, American Medical Association, Targeted drug delivery, Conference, American Academy of Ophthalmology, R, Diabetes, Diabetic retinopathy, Webcast, Literature, American Academy, Administration, DME, G&A, Research and development, Physician, Paratriathlon, Retina, Drug delivery, Pharming, Eye, Intravitreal injection, BioCryst Pharmaceuticals, SCS, Edema, AAO, Melanoma, AURA, Solubility, Partnership, AMD, Clearside, Bausch & Lomb, OASIS, Axitinib, Plasma, Clinical trial, CLS, CPT, Conference call, UME, Injection, HIV disease progression rates, Pharmaceutical industry, Nursing, Video game

ALPHARETTA, Ga., Nov. 13, 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®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Nov. 13, 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®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • Other Income: Other income for the third quarter of 2023 was $0.4 million, compared to $0.2 million for the third quarter of 2022.
  • Other Expense: Non-cash interest expense for the third quarter of 2023 was $2.6 million, compared to $1.3 million in the third quarter of 2022.
  • Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

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)

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Tuesday, December 5, 2023
Health, Communications, Clinical Trials, Pharmaceutical, Publishing, Optical, Biotechnology, Yoshi, Intravitreal injection, Safety, Visual acuity, Retina, Royal college, Anatomy, Risk, Exudate, Anti-VEGF, FGF2, Patient, P, Choroidal neovascularization, Aptamer, Eye, Therapy, Blood, Growth factor, Royal College of Ophthalmologists, Paratriathlon, NAMD, SUSHI, Fibrosis, Pharmaceutical industry, D.S

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.

OliX Pharmaceuticals Announces Positive Safety Data and Preliminary Efficacy Effects in a Phase 1 Trial of OLX10212 for Age-Related Macular Degeneration

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Wednesday, November 29, 2023
Seniors, Biotechnology, Pharmaceutical, Optical, Health, Genetics, Consumer, Clinical Trials, Intravitreal injection, Safety, Neovascularization, Visual acuity, RNA interference, Homeostasis, Vance DeGeneres, Patient, Small RNA, DLT, Therapy, RNA, Harvard Medical School, AMD, Macular degeneration, Sirna Therapeutics, KOSDAQ, Quality of life, Paratriathlon, Inflammation, Optimism, Pharmaceutical industry

OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced positive results from a Phase 1 study evaluating the safety and tolerability of OLX10212 for the treatment of Age-Related Macular Degeneration (AMD).

Key Points: 
  • OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced positive results from a Phase 1 study evaluating the safety and tolerability of OLX10212 for the treatment of Age-Related Macular Degeneration (AMD).
  • This phase 1 study is a multi-center, single-dose, dose-escalating study to evaluate the safety and tolerability of OLX10212 in patients with neovascular AMD.
  • The primary endpoints of this study were safety and tolerability assessments associated with each intravitreal OLX10212 injection.
  • The safety and tolerability evaluations, together with preliminary BCVA improvement of OLX10212 encourage further development of OLX10212 for AMD.

Akari Therapeutics to Present a Poster on Pre-Clinical Development of Long-Acting PAS-Nomacopan as a Potential Treatment for Geographic Atrophy at the 4th Annual Dry AMD Therapeutic Development Conference

Retrieved on: 
Monday, November 6, 2023
Choroidal neovascularization, CNV, Intravitreal injection, C5, Treatment, Geographic atrophy, Poster, Leukotriene B4, Hot game, LTB4, Therapy, Pharmaceutical industry

BOSTON and LONDON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Chief Scientific Officer Miles Nunn will present a poster titled Development of PASylated®-Nomacopan for Treatment of Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (dAMD) at the 4th Annual Dry AMD Therapeutic Development conference taking place November 14-16 in Boston, MA.

Key Points: 
  • BOSTON and LONDON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Chief Scientific Officer Miles Nunn will present a poster titled Development of PASylated®-Nomacopan for Treatment of Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (dAMD) at the 4th Annual Dry AMD Therapeutic Development conference taking place November 14-16 in Boston, MA.
  • The poster will be presented on November 15, 2023 at 3:00 pm ET.
  • Long-acting PAS-nomacopan is a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4).
  • It is in the final stages of pre-clinical development as a potential treatment for GA with the goals of providing a longer dose interval between intravitreal injections and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors currently used in GA treatment.

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

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Thursday, November 2, 2023
FDA, Food, DR, Intravitreal injection, Physician, MBA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Diabetic retinopathy, Protocol, Diabetes, RCA, DRSS, M.D, Safety, Patient, Retina, OCUP, Pharmaceutical industry

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.”

Oculis to Present a Late-Breaking Abstract at the American Academy of Ophthalmology 2023 Annual Meeting on the Positive Stage 1 Results from Phase 3 DIAMOND Trial for Diabetic Macular Edema

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Wednesday, November 1, 2023
Cerebral edema, CME, Intravitreal injection, Diabetic retinopathy, DME, AAO, Dexamethasone, Diabetes, Inflammation, OCS, American Academy, 2008 Giro d'Italia, Stage 1 to Stage 11, American Academy of Ophthalmology, Annual general meeting, Paratriathlon, Pain, Patient, Trial of the century, Retina, Pharmaceutical industry

A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 Eye Drops in Diabetic Macular Edema (DME)

Key Points: 
  • A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 Eye Drops in Diabetic Macular Edema (DME)
    OCS-01 is Oculis’ lead product candidate and the first investigational eye drop for both front and back of the eye indications, with positive results in Stage 1 of the Phase 3 DIAMOND trial for DME announced in May 2023, and positive Phase 3 OPTIMIZE trial results for inflammation and pain following cataract surgery announced in August 2023.
  • Furthermore, the investigator-initiated LEOPARD study evaluating OCS-01 for the treatment of cystoid macular edema (CME) enrolled its first patient in August 2023.
  • Leveraging Oculis’ proprietary OPTIREACH® technology, OCS-01 is a novel, high concentration (15 mg/ml), topical formulation of dexamethasone.
  • If approved, OCS-01 has the potential to become the first topical preservative-free eye drop for the treatment of DME, the leading cause of vision loss and legal blindness in patients with diabetes.

Ashvattha Therapeutics Announces First Patient Dosed via Subcutaneous Administration of Anti-Angiogenic Therapeutic D-4517.2 for Wet AMD and DME in Phase 2 Chronic Dosing Study

Retrieved on: 
Wednesday, November 1, 2023
CST, Therapy, Intravitreal injection, AMD, DME, Nanomedicine, Inflammation, Eye, Safety, Anxiety, Visual acuity, Patient, Pharmaceutical industry, Vaccine

The open-label study will evaluate the safety and efficacy of chronic D-4517.2 dosing in patients with wet AMD and DME.

Key Points: 
  • The open-label study will evaluate the safety and efficacy of chronic D-4517.2 dosing in patients with wet AMD and DME.
  • “This study marks a significant step forward in advancing D-4517.2 as an at-home, maintenance treatment option for patients with wet AMD and DME.
  • Following the return of fluid to baseline levels, subjects will be concurrently dosed with both aflibercept and D-4517.2.
  • The initiation of the Phase 2 chronic dosing study is supported by results from Phase 1 and Phase 2 single dose studies that demonstrated good safety and tolerability of D-4517.2.

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

Retrieved on: 
Monday, October 30, 2023
Biomarker, Ophthalmology, Institutional review board, Intravitreal injection, Hematology, AMD, BrightFocus Foundation, MD, Research, Anti-VEGF, OTCQB, JAMA Ophthalmology, News, Disease, University, Personalized medicine, Blood, Safety, Patient, Pharmaceutical industry

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.

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.