Phentolamine

Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions

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Giovedì, Gennaio 4, 2024
Presbyopia, SPA, Pupil, Ciliary muscle, Food, FDA, GLARE, Night vision, Protocol, OCUP, Phentolamine, Patient, Safety, Viatris, Pharmaceutical industry

“The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire.

Key Points: 
  • “The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire.
  • LYNX-2 will be a multi-center, randomized, double-masked, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of phentolamine ophthalmic solution in up to 200 patients in the U.S.
  • Under the terms of the November 2022 license agreement, Viatris will fund the development of phentolamine ophthalmic solution for the treatment of decreased visual acuity under dim (mesopic) light conditions and presbyopia.
  • Ocuphire is eligible to receive a milestone payment upon FDA approvals in these indications.

Ocuphire Pharma Announces Financial Results for Third Quarter 2022 and Provides Corporate Update

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Venerdì, Novembre 4, 2022
Private Securities Litigation Reform Act, OCUP, Diabetic retinopathy, NVD, FDA, Tufts Medical Center, Pilocarpine, OD, Research, U.S. Securities and Exchange Commission, Patent, Light, Inflammation, SEC, Company, Growth, CA, Element, Food, GLOBE, Consultant, BioMed Central, Ophthalmology, CEO, Retina, Night vision, PDUFA, MBA, Security (finance), MAB, Patient, Doctor of Philosophy, Cleveland, Maintenance, KOL, Prescription Drug User Fee Act, Risk, Method, Cleveland Clinic, 1836 U.S. Patent Office fire, COVID-19, Review, LDP, DME, Food and Drug Administration, American Academy, Industry, Safety, Phentolamine, Internet, Presbyopia, Nasdaq, NDA, New Drug Application, BMC, Pharmaceutical industry, Mydriasis, DR, MD

FARMINGTON HILLS, Mich., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, announces financial results for the third quarter ended September 30, 2022 and provides a corporate update.

Key Points: 
  • FARMINGTON HILLS, Mich., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, announces financial results for the third quarter ended September 30, 2022 and provides a corporate update.
  • We are on track for NDA submission for Nyxol for reversal of mydriasis in the fourth quarter 2022.
  • On August 2, 2022, Ocuphire was granted extended intellectual property protection for Nyxol with the issuance of U.S. Patent No.
  • Third Quarter Ended September 30, 2022, Financial Highlights
    As of September 30, 2022, Ocuphire had cash and cash equivalents of approximately $13.9 million.

Ocuphire Pharma Announces Financial Results for the Second Quarter 2022 and Provides Corporate Update

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Venerdì, Agosto 12, 2022
OCUP, U.S. Securities and Exchange Commission, Risk, CEO, GLOBE, SEC, Clinical trial, Patent, Board, Reversal, Security (finance), NVD, Method, Patient, ASRS, Board of directors, Diabetes, OD, NDA, Inflammation, Industry, Phentolamine, Private Securities Litigation Reform Act, APX, Pilocarpine, DNA, Diabetic retinopathy, Safety, Doctor of Philosophy, Nasdaq, CMC, Ageing, Visual acuity, DME, Use, Frontiers, COVID-19, LDP, Maintenance, Expected, NF-κB, FDA, Observation, Chronic pain, Society, Light, Review, Company, NASDAQ, Research, MBA, Retina, Pharmaceutical industry, Medical device, Tutoring, Online gambling, MD, Presbyopia, Mydriasis, RM, DR

FARMINGTON HILLS, Mich., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Key Points: 
  • We look forward to reporting top-line results in the second half of this year from the Phase 2b trial of APX3330 in diabetic retinopathy (DR).
  • We are well positioned to deliver on our upcoming late-stage clinical and regulatory milestones through the second half of 2022.
  • Second Quarter Ended June 30, 2022 Financial Highlights
    As of June 30, 2022, Ocuphire had cash and cash equivalents of approximately $17.0 million.
  • Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.