LONDON and NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announced upcoming presentations at two investor conferences in May 2024.
Key Points:
- LONDON and NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announced upcoming presentations at two investor conferences in May 2024.
LONDON and NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be rescheduling a Key Opinion Leader (KOL) event entitled “KOL Event Presenting Comprehensive Detailed Results from the Phase 2 Trial of OK-101 in Dry Eye Disease” originally planned for April 9th, 2024 at 12:00 PM ET until May 2024.
Key Points:
- LONDON and NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be rescheduling a Key Opinion Leader (KOL) event entitled “KOL Event Presenting Comprehensive Detailed Results from the Phase 2 Trial of OK-101 in Dry Eye Disease” originally planned for April 9th, 2024 at 12:00 PM ET until May 2024.
- The Company is rescheduling its event so that it can incorporate additional key analyses of its clinical data which it plans to present at upcoming ophthalmic conferences.
- OKYO is planning to make a presentation at “Dry Horizons Symposium Navigating the Future of Dry Eye Research”, an event preceding the Association for Research in Vision and Ophthalmology (ARVO) conference with details provided below.
LONDON and NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announced an upcoming presentation of the OK-101 Phase 2 data for dry eye disease at Eyecelerator 2024, a partner meeting of the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, being held April 4, 2024 in Boston, MA.
Key Points:
- LONDON and NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announced an upcoming presentation of the OK-101 Phase 2 data for dry eye disease at Eyecelerator 2024, a partner meeting of the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, being held April 4, 2024 in Boston, MA.
Day,
Ora,
Dry,
NCP,
Conjunctiva,
BID,
Physiology,
Patient,
Pain,
Ophthalmology,
Observation,
Blurred Vision,
Doctor of Philosophy,
Itch,
DED,
MOA,
Safety,
Screen time,
Telecanthus,
Medical director,
FDA,
Pharmaceutical industry Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial.
Key Points:
- Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial.
- Tear Film Break-up Time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial.
- Burning/Stinging, and Blurred Vision improved as early as day 15 and the benefit remained durable throughout the trial.
- Significant improvements were observed across multiple symptoms as measured in a daily symptom diary including pain, burning/stinging, eye dryness and itching within the first two weeks of treatment.
Visual Science,
Uveitis,
Wilmer Ophthalmological Institute,
Brandeis University,
Neurophysiology,
NCP,
BID,
Telecanthus,
Research,
KOL,
University,
Patient,
Doctor of Philosophy,
Bascom Palmer Eye Institute,
DED,
Georgetown University Medical Center,
Pain,
Therapy,
Johns Hopkins Hospital,
Medical director,
FDA,
Pharmaceutical industry LONDON and NEW YORK, March 21, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be hosting a Key Opinion Leader (KOL) event on April 9th, 2024 at 12:00 PM ET to discuss in depth the findings of the new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease, which will be announced on March 22nd, 2024.
Key Points:
- OKYO Pharma’s management team will also be in attendance to present an overview of OK-101’s mechanism of action.
- He has published over 200 peer-reviewed articles and has served on the editorial boards of several prestigious ophthalmology journals.
- Additionally, statistically significant improvements were observed in both a “sign” (total conjunctival staining) and two “symptoms” (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.
- The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID).
Retrieved on:
Wednesday, March 20, 2024
NCP,
BID,
Patient,
KOL,
IND,
DED,
Safety,
Pain,
Telecanthus,
FDA,
Health,
Pharmaceutical industry The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.
Key Points:
- The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.
- Additionally, statistically significant improvements were observed in both a “sign” (total conjunctival staining) and two “symptoms” (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.
- The KOL call will feature prominent experts in the field of dry eye disease.
- “The upcoming data release follows the successful completion of OKYO Pharma's Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
Tufts Medical Center,
MD,
Pain,
Investigational New Drug,
FDA,
Food,
DED,
Principal investigator,
IND,
Clinical trial,
Patient,
NCP,
Disease,
Pharmaceutical industry Notably, the initial IND submission to FDA proposed an open-label design for the clinical trial.
Key Points:
- Notably, the initial IND submission to FDA proposed an open-label design for the clinical trial.
- Based on positive feedback from FDA, the Phase 2 study is now designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients.
- A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy.
- OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce ocular neuropathic pain.
Retrieved on:
Wednesday, January 31, 2024
Uveitis,
Telecanthus,
Research,
University,
Yale School of Medicine,
Patient,
Pain,
Wilmer Ophthalmological Institute,
Safety,
FDA,
NCP,
Physician,
DED,
Eye,
DRS,
Bascom Palmer Eye Institute,
Garden,
Pharmaceutical industry and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.
Key Points:
- and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board.
- Dr Victor Perez is a Director of Cornea Research at Bascom Palmer Eye Institute, at the University of Miami Miller School of Medicine.
- He is a clinician-scientist investigator in the field of ocular immunology and ocular surface diseases and served as Director of Duke Eye Center’s Ocular Immunology Center before joining Bascom Palmer Eye Institute.
- OKYO's Scientific Advisory Board now has an ideal blend of clinical expertise, including ocular surface disease and neuropathic corneal pain, from the leading experts in those fields."
Patient,
DED,
BID,
Plasma protein binding,
Dry,
FDA,
Ophthalmology,
Medical director,
Lubrication,
Human,
Ora,
Telecanthus,
B cell,
Safety,
Conjunctiva,
Pharmaceutical industry This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.
Key Points:
- This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.
- The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID).
- OK-101 First-In-Human trial establishes a clear clinical path for further clinical development in a Phase 3 study design using FDA recognized endpoints per the Dry Eye: Developing Drugs for Treatment Guidance for Industry.
- A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01).
The OKYO management team will also be participating in one-on-one partnering meetings throughout the conference.
Key Points:
- The OKYO management team will also be participating in one-on-one partnering meetings throughout the conference.
- OKYO Pharma has just completed a phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat 240 patients with dry eye disease (DED).
- The conference takes place each year in San Francisco during the course of one of the industry's largest gatherings and busiest weeks.
- “We are delighted that OKYO Pharma will be joining us in San Francisco and presenting at Biotech Showcase this year,” said Sara Demy, CEO of Demy-Colton.
