IVIEW Announces Presentation of Positive Topline Results in Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis at ARVO 2024
Cranbury, NJ, February 28, 2024 --(PR.com)-- IVIEW Therapeutics Inc. announces to present the positive topline result in the Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis in the upcoming 2024 ARVO (The Association for Research in Vision and Ophthalmology) national meeting in Seattle, WA. The Presentation is scheduled as an oral presentation at 9:15am on May 7, 2024. The presentation will report topline data on a recently completed Phase II, Multi-Center, Blinded, Randomized, Parallel-Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone Iodine) Gel Forming Ophthalmic Solution Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis.
This multi-center, blinded, randomized, parallel, positive control with Ofloxacin for the treatment of acute bacterial conjunctivitis Phase II Clinical Trial was granted by FDA and China NMPA and led by lead investigators Dr. Weiyun Shi and Dr. Ting Wang at the Eye Hospital of Shandong First Medical University. This clinical trial has enrolled 129 patients in 12 sites across China. The prespecified primary endpoint (clinical cure rate at Day 8) of non-inferiority to Ofloxacin achieved. Notably, IVIEW-1201 showed superior clinical cure results to Ofloxacin in subjects with negative bacterial culture at baseline. The Phase II trials has also demonstrated good safety and tolerability.
Infectious conjunctivitis is a common and frequently occurring disease in ophthalmic clinics, and it mainly caused by viral or bacterial infections. At present, the conventional treatment is based on antibiotics or combination with other drugs. However, it is difficult to distinguish between bacterial and viral infections, there is an unmet clinical need for a drug that can treat any source of infections, such as viruses and bacteria, to treat the common acute conjunctivitis (“pink eye”)”.
Francis Mah, MD, Director of Cornea and External Disease and the Co-Director, Refractive Surgery at Scripps Clinic Medical Group in La Jolla, California, is the designer of the trial protocol. Dr. Mah commented, “I am pleased to report the topline data of this phase II trial to the ophthalmology community, and I look forward to working with the company for future pivotal trials after discussions with the regulatory agency”.
Dr. Bo Liang, Co-founder, Chairman and CEO of IVIEW Therapeutics Inc. commented; “IVIEW-1201 is a broad-spectrum non-antibiotic innovative eye drop, which can potentially treat both viral and bacterial conjunctivitis without potential drug resistance. If IVIEW-1201 is successfully developed to treat infectious conjunctivitis, it will provide an innovative solution for eye infections and fill up the significant unmet medical need."
In addition to the paper presentation, 3 poster presentations from IVIEW Therapeutics were also accepted to present in the ARVO 2024 meeting:
Poster 3639-B0302, Development of a Long-Lasting In-situ Gel-Forming Solution for the Treatment of Conjunctivitis. 1:15-3pm May 7, 2024
Poster 5130-A0430, A novel AAV-based gene therapy for glaucoma treatment. 2:15-4:00pm May 8, 2024
Poster 5763 -B0327, Nonclinical Development of a Novel Therapeutic Ophthalmic Eyelid Wipe to Treat Dry Eye Disease. 8:00-9:45am May 9, 2024
About iVIEW Therapeutics Inc.
iVIEW Therapeutics Inc. is a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics.. We are driven by the pursuit of innovative science that leads to differentiated products to fulfill unmet medical needs. We invest in novel mechanisms of action, and differentiated drug delivery technology platforms that allow us to bring forward assets with potentially superior target product profiles. The company's innovative eye drugs cover dry eye, myopia, conjunctivitis, presbyopia, and innovative gene therapy. The U.S. headquarters is located in Cranbury, Princeton, New Jersey with an 11,045 sq. ft. Laboratory and office space in the Princeton area.
For details, please refer to the company websites: www.iVIEWtherapeutics.com. For media contact, please contact Ms. Kylie Fon at info@iviewinc.com.
This multi-center, blinded, randomized, parallel, positive control with Ofloxacin for the treatment of acute bacterial conjunctivitis Phase II Clinical Trial was granted by FDA and China NMPA and led by lead investigators Dr. Weiyun Shi and Dr. Ting Wang at the Eye Hospital of Shandong First Medical University. This clinical trial has enrolled 129 patients in 12 sites across China. The prespecified primary endpoint (clinical cure rate at Day 8) of non-inferiority to Ofloxacin achieved. Notably, IVIEW-1201 showed superior clinical cure results to Ofloxacin in subjects with negative bacterial culture at baseline. The Phase II trials has also demonstrated good safety and tolerability.
Infectious conjunctivitis is a common and frequently occurring disease in ophthalmic clinics, and it mainly caused by viral or bacterial infections. At present, the conventional treatment is based on antibiotics or combination with other drugs. However, it is difficult to distinguish between bacterial and viral infections, there is an unmet clinical need for a drug that can treat any source of infections, such as viruses and bacteria, to treat the common acute conjunctivitis (“pink eye”)”.
Francis Mah, MD, Director of Cornea and External Disease and the Co-Director, Refractive Surgery at Scripps Clinic Medical Group in La Jolla, California, is the designer of the trial protocol. Dr. Mah commented, “I am pleased to report the topline data of this phase II trial to the ophthalmology community, and I look forward to working with the company for future pivotal trials after discussions with the regulatory agency”.
Dr. Bo Liang, Co-founder, Chairman and CEO of IVIEW Therapeutics Inc. commented; “IVIEW-1201 is a broad-spectrum non-antibiotic innovative eye drop, which can potentially treat both viral and bacterial conjunctivitis without potential drug resistance. If IVIEW-1201 is successfully developed to treat infectious conjunctivitis, it will provide an innovative solution for eye infections and fill up the significant unmet medical need."
In addition to the paper presentation, 3 poster presentations from IVIEW Therapeutics were also accepted to present in the ARVO 2024 meeting:
Poster 3639-B0302, Development of a Long-Lasting In-situ Gel-Forming Solution for the Treatment of Conjunctivitis. 1:15-3pm May 7, 2024
Poster 5130-A0430, A novel AAV-based gene therapy for glaucoma treatment. 2:15-4:00pm May 8, 2024
Poster 5763 -B0327, Nonclinical Development of a Novel Therapeutic Ophthalmic Eyelid Wipe to Treat Dry Eye Disease. 8:00-9:45am May 9, 2024
About iVIEW Therapeutics Inc.
iVIEW Therapeutics Inc. is a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics.. We are driven by the pursuit of innovative science that leads to differentiated products to fulfill unmet medical needs. We invest in novel mechanisms of action, and differentiated drug delivery technology platforms that allow us to bring forward assets with potentially superior target product profiles. The company's innovative eye drugs cover dry eye, myopia, conjunctivitis, presbyopia, and innovative gene therapy. The U.S. headquarters is located in Cranbury, Princeton, New Jersey with an 11,045 sq. ft. Laboratory and office space in the Princeton area.
For details, please refer to the company websites: www.iVIEWtherapeutics.com. For media contact, please contact Ms. Kylie Fon at info@iviewinc.com.
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iView Therapeutics Inc.
Kylie Fon
(609) 773-8580
https://www.iviewtherapeutics.com/
Kylie Fon
(609) 773-8580
https://www.iviewtherapeutics.com/
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