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Ocuphire Pharma Announces Presentation on APX3330 at the ARVO 2024 Annual Meeting

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星期一, 五月 6, 2024

FDA, DRSS, PDR, Safety, Risk, Food, Diabetic retinopathy, Research, OCUP, Binocular, Retina, Patient, Eye, Annual general meeting, ARVO, DR, Pharmaceutical industry

ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.

Key Points:

ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.
This 17-step person-level scale accounts for the DRSS scores of the two eyes and then anchors the step to the worse eye.
Fewer participants in the APX3330 group developed proliferative diabetic retinopathy (PDR) by week 24 compared to the placebo group (11% vs 26% respectively; p=0.13).
APX3330 showed favorable safety and tolerability, with similar ocular adverse events between APX3330 and placebo groups.

Ocuphire Pharma to Present at the Aegis Virtual Conference

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星期五, 五月 3, 2024

OCUP, Conference, Cryptocurrency

FARMINGTON HILLS, Mich., May 03, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that George Magrath, M.D.

Key Points:

FARMINGTON HILLS, Mich., May 03, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that George Magrath, M.D.
M.B.A., M.S., Chief Executive Officer of Ocuphire, will present a company overview at the Aegis Virtual Conference being held May 7-9, 2024.
Company management will also be participating in one-on-one meetings throughout the conference.
Key details about Dr. Magrath’s presentation at the Aegis Capital Virtual Conference are below:
Aegis Capital Virtual Conference – May 7-9, 2024
If you are interested in arranging a one-on-one meeting, please contact your conference representative or send an email to [email protected].

Ocuphire Pharma Announces APX3330 Presentation at ARVO 2024 Annual Meeting

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星期一, 四月 22, 2024

Research, OCUP, Annual general meeting, ARVO

FARMINGTON HILLS, Mich., April 22, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that Daniel Su, M.D.

Key Points:

FARMINGTON HILLS, Mich., April 22, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that Daniel Su, M.D.
will deliver a paper presentation on oral APX3330 at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 5-9, 2024 in Seattle, Washington.
Key details about Dr. Su’s presentation at the ARVO 2024 Annual Meeting are below:

First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the Treatment of Decreased Visual Acuity Under Low Light Conditions Following Keratorefractive Surgery

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星期四, 四月 11, 2024

PS, FDA, Ciliary muscle, Patient, IOL, SPA, Food, DSM-IV codes, OCUP, RK, Viatris, Aberration, Protocol, GLARE, Keratoconus, SMILE, Ophthalmology, Pupil, Visual acuity, Pharmaceutical industry

FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery.

Key Points:

“We are pleased to begin enrollment in the LYNX-2 study of PS,” said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire.
Patients experience decreased low contrast visual acuity as well as glare, halos and starbursts.
There are currently no FDA-approved treatments for visual disturbances under low light conditions.
LYNX-2 is a randomized, double-masked, placebo-controlled Phase 3 registration study designed to evaluate the safety and efficacy of PS compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions.

Ocuphire Announces the U.S. Commercial Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution 0.75%) by its Partner Viatris

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星期一, 四月 1, 2024

Viatris, Patient, OCUP

FARMINGTON HILLS, Mich., April 01, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS).

Key Points:

FARMINGTON HILLS, Mich., April 01, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) by its partner Viatris Inc. (NASDAQ: VTRS).
Ocuphire has a global license agreement with Viatris to co-develop and commercialize Phentolamine Ophthalmic Solution 0.75%.
Under the terms of this agreement, Ocuphire is eligible to receive regulatory and commercial milestones as well as royalties.

Ocuphire Pharma Announces Financial Results for Fourth Quarter and Full Year 2023 and Provides Corporate Update

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星期五, 三月 8, 2024

OCUP, Research, Mydriasis, FDA, Protocol, PS, Presbyopia, Calendar, Diabetic retinopathy, Interim, Safety, DR, Diabetes, Patient, SPA, Security (finance), Ash, LPC, Pharmaceutical industry

In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.

Key Points:

In October 2023, Ocuphire held an End-of-Phase 2 meeting with the FDA and aligned on the registrational primary endpoint of 3-step or more worsening on binocular DRSS Person scale.
In February 2024, Ocuphire submitted a Special Protocol Assessment (“SPA”) to seek agreement on the clinical trial protocol and statistical analysis plan for Phase 3.
In September 2023, Ocuphire and Viatris, Inc. (“Viatris”) announced FDA approval of PS under the brand name RYZUMVI™ for the treatment of pharmacologically-induced mydriasis.
Financial Highlights for the Fourth Quarter and Full Year Ended December 31, 2023
As of December 31, 2023, Ocuphire had cash and cash equivalents of approximately $50.5 million.

Ocuphire Pharma to Present in the BIO CEO & Investor Conference

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星期五, 二月 23, 2024

OCUP, BIO, Conference

FARMINGTON HILLS, Mich., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), 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 George Magrath, M.D.

Key Points:

FARMINGTON HILLS, Mich., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), 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 George Magrath, M.D.
CEO of Ocuphire, will be presenting a company overview at the BIO CEO & Investor Conference being held February 26-27 2024 in New York City.
Company management will also be participating in one-on-one meetings throughout the conference.
BIO CEO & Investor Conference – February 26-27, 2024

Ocuphire Pharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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星期四, 二月 15, 2024

OCUP, Employment, Acceleration, Lease

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

Key Points:

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.
In connection with entering into employment with Ocuphire, Dr. Jayagopal, who was not a previous employee or director of Ocuphire, received an option to purchase 225,000 shares of the Company’s common stock and 75,000 restricted stock units (“RSUs”).
The option award has an exercise price of $2.66 per share, the closing price of Ocuphire’s common stock on February 12, 2024.
The option award has an exercise price of $2.66 per share, the closing price of Ocuphire’s common stock on February 12, 2024.

Ocuphire Pharma Strengthens Leadership Team with Key Appointments

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星期三, 二月 14, 2024

FARMINGTON HILLS, Mich., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), 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 appointments of Ash Jayagopal, Ph.D., M.B.A. as Chief Scientific and Development Officer, and Nirav Jhaveri, C.F.A., M.B.A. as Chief Financial Officer, effective today.

Key Points:

The team is now set and focused on executing our phase 3 program to turn our science into a reality for patients suffering from diabetic retinopathy, the leading cause of blindness in America.
I'm excited to work alongside such a talented team and together to take on significant unmet medical needs with compelling science.”
Dr. Jayagopal added, “I am excited to join the talented Ocuphire team that has a successful track record in drug development and execution.
Prior to joining Ocuphire, he served as the Chief Scientific Officer of Opus Genetics.
In this role he had scientific and clinical leadership responsibility for Opus’ retinal gene therapy portfolio, including management of discovery, manufacturing, nonclinical development, and clinical development functions.

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

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星期一, 二月 5, 2024

PDR, Conference, DRSS, Diabetes, Patient, FDA, Retina, Physician, Week, Diabetic retinopathy, Binocular, Angiogenesis, University, OCUP, Champaign–Urbana metropolitan area, Pharmaceutical industry

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.”