Ciliary muscle

PulseSight Therapeutics Launches to Advance Non-viral Gene Therapies with Disruptive Minimally-Invasive Delivery Technology for Severe Retinal Diseases

Retrieved on: 
Wednesday, February 28, 2024
Doctor of Philosophy, Decorin, Drug development, Sale, Iris (anatomy), Transferrin, Ciliary muscle, Geographic atrophy, Ranibizumab, Iron, Retinitis pigmentosa, Retina, CNV, Paratriathlon, Eye, Brolucizumab, VEGF, Therapy, AMD, Independent, DNA, Retinal pigment epithelium, KIP, Doctor of Pharmacy, Safety, Novartis, Oxidative stress, CSO, Conditional sentence, RPE, EMA, MD, FDA, SAS, Choroidal neovascularization, Cell, Human, Patient, Glaucoma, Gene expression

Unique proprietary non-viral gene therapy platform with minimally invasive delivery technology providing long lasting gene expression and favorable distribution in the retina.

Key Points: 
  • Unique proprietary non-viral gene therapy platform with minimally invasive delivery technology providing long lasting gene expression and favorable distribution in the retina.
  • A substantially de-risked platform and two first-in-class gene therapies heading to the clinic, having the potential to become future blockbusters.
  • PARIS, Feb. 28, 2024 (GLOBE NEWSWIRE) -- PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral gene therapies with minimally-invasive delivery technology, launches today with seed finance from Pureos Bioventures and ND Capital.
  • PulseSight is currently raising a Series A financing round to advance its programs into clinical proof-of-concept.

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

Retrieved on: 
Thursday, January 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 Submission of New Drug Application to FDA for Nyxol® Eye Drops for Reversal of Mydriasis

Retrieved on: 
Tuesday, December 6, 2022
Acquisition, Ophthalmology, MIRA, Pupil, Partnership, NVD, Food, FDA, Light, OCUP, Maintenance, Sept, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tropicamide, Risk, DR, DME, Diabetic retinopathy, Phenylephrine, Ageing, NDA, Growth, MBA, Ciliary muscle, Presbyopia, Parasympatholytic, COVID-19, Patient, Pilocarpine, Pharmaceutical industry, RM

If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.

Key Points: 
  • If approved, Nyxol is expected to be the only commercially available treatment option indicated for the reversal of dilated eyes.
  • If Nyxol is approved for RM in the US, Ocuphire is eligible to receive a $10 million milestone payment.
  • Nyxol is being developed for reversal of pharmacologically-induced mydriasis (RM), presbyopia, and night (or dim light) vision disturbances (NVD) under the 505(b)(2) pathway.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Ocuphire Extends U.S. Patent Protection for Late-Stage Drug Candidate Nyxol® for Reversal of Mydriasis by Five More Years into 2039 with New Patent Issuance

Retrieved on: 
Wednesday, August 3, 2022
Patent, Intellectual property, Private Securities Litigation Reform Act, COVID-19, Diabetic retinopathy, DME, Eye, Pupil, Risk, Company, Light, Color, Review, NDA, Nasdaq, NVD, Retinal detachment, FDA, OCUP, Mydriasis, Maintenance, DR, Presbyopia, Miosis, Ciliary muscle, Method, United States patent law, GLOBE, MBA, SEC, CEO, Approved Drug Products with Therapeutic Equivalence Evaluations, NASDAQ, Pharmaceutical industry, RM

FARMINGTON HILLS, Mich., Aug. 03, 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 the issuance of U.S. Patent No. 11,400,077. The patent provides added intellectual property protection for the company’s late-stage product candidate, Nyxol (phentolamine mesylate), with claims directed to methods for treating mydriasis using phentolamine mesylate. The patent is eligible for listing in the U.S. FDA Orange Book and has a term extending into year 2039.

Key Points: 
  • The patent provides added intellectual property protection for the companys late-stage product candidate, Nyxol (phentolamine mesylate), with claims directed to methods for treating mydriasis using phentolamine mesylate.
  • The patent is eligible for listing in the U.S. FDA Orange Book and has a term extending into year 2039.
  • We are very pleased with the issuance of this new patent for Nyxol, which extends our intellectual property protection in the U.S. by an additional five years into 2039, said Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma.
  • Ocuphires patent estate for Nyxol includes patents and patent applications for phentolamine mesylate formulations and methods of using phentolamine mesylate.

Arctic Vision Announces First Patient Enrolled in Phase III Clinical Trial of ARVN003 for Presbyopia

Retrieved on: 
Monday, July 4, 2022
Ageing, Patient, Life, Electronics, DME, Trial of the century, Population, Disease, MAP, Phase, Compliance, Presbyopia, Latanoprost, Ciliary muscle, Mapy Cortés, Vision, Clinical trial, Technology, Visual acuity, IOP, The Affiliated Eye Hospital, Lens (anatomy), Entrepreneurship, Wenzhou Medical University, Time, Microcline, Safety, Pupil, Eye, Pilocarpine, Principal investigator, Pharmaceutical industry, Telescopic sight

SHANGHAI, July 4, 2022 /PRNewswire/ -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.

Key Points: 
  • This is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
  • The Phase III study is double-masked, placebo-controlled, randomized, and multicenter trial evaluating the efficacy and safety of ARVN003 in achieving temporary improvement of vision in adults with presbyopia.
  • It is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
  • Dr. Qing Liu, Co-Founder and Chief Medical Officer at Arctic Vision added, "ARVN003's significant clinical progress is encouraging.

Eyevensys Recaps Highlights from Investigator Meeting and Presentations at the ARVO 2022 Annual Conference

Retrieved on: 
Wednesday, May 11, 2022
Biotechnology, Pharmaceutical, Surgery, General Health, Health, FDA, Clinical Trials, Other Health, United Kingdom, Glaucoma, Retinitis pigmentosa, VEGF, CNV, NIU, EMT, Safety, ARVO, Research, Electroporation, Eye, DCN, Fibrosis, IgG4-related ophthalmic disease, Association, Ciliary muscle, Clinical trial, Retina, Diabetic retinopathy, Annual conferences, Human, Association for Research in Vision and Ophthalmology, DNA, Severe cognitive impairment, Choroidal neovascularization, ADA, Transitive relation, Conference, Kaleidoscope, AMD, Recurrence, DSMB, Vaccine, Pharmaceutical industry, EU, Ophthalmology, Transferrin, Decorin

Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today provided highlights from the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference held in Denver, Colorado.

Key Points: 
  • Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today provided highlights from the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Conference held in Denver, Colorado.
  • This includes two out of the three US subjects whose disease signs and symptoms improved after treatment with EYS606.
  • Dr. Srivastava, a uveitis Key Opinion Leader, qualified these two improvements as non-expected for this disease population and related to the EYS606 treatment.
  • In a separate meeting, the DSMB members concluded that no safety concerns were associated with the EYS606 plasmid or the Eyevensys Electrotransfection Platform.

Ocuphire Completes Last Clinical Trial Supporting the Planned 2022 NDA Submission with the Announcement of Positive Results from MIRA-4 Pediatric Safety Trial Evaluating Nyxol® for Reversal of Mydriasis

Retrieved on: 
Thursday, April 28, 2022
Diabetic retinopathy, Myopia, Vital signs, FDA, Pupil, Sport, OCUP, Consistency, NASDAQ, SEC, Review, MIRA, Safety, Mydriasis, Headache, Parent, DR, GLOBE, DME, Red, Ophthalmology, American Association, Profile, Private Securities Litigation Reform Act, NDA, Amblyopia, CEO, Pediatrics, PD, COVID-19, Prevalence, Risk, Presbyopia, Light, Strabismus, MBA, Phenylephrine, Ciliary muscle, Maintenance, Tropicamide, Stinger, Association, Nasdaq, Pain, Color, American Association for Pediatric Ophthalmology and Strabismus, Â, Eye, Physician, Pharmaceutical industry, Birth control, Palladium, NVD, Optometry, RM

 FARMINGTON HILLS, Mich., April 28, 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 positive results in the MIRA-4 pediatric safety trial investigating its product candidate Nyxol® for the reversal of pharmacologically-induced mydriasis (dilation of pupil). The results demonstrated that Nyxol’s efficacy and safety in pediatric subjects 3-11 years of age was consistent with that shown in previous studies conducted by Ocuphire which enrolled both adolescents (age 12-17 years) and adults (age 18 years and older), showing a rapid reversal of pharmacologically-induced mydriasis (RM) and a favorable safety profile.

Key Points: 
  • Ocuphire plans to submit an NDA that includes the results of MIRA-1, MIRA-2, MIRA-3, and MIRA-4 with the U.S. FDA in late 2022.
  • MIRA-4 ( NCT05223478 ) is a pediatric trial evaluating the safety and efficacy of Nyxol in healthy subjects with pharmacologically-induced mydriasis as agreed with the FDA under the Pediatric Research Equity Act.
  • Ocuphire has reported positive data from MIRA-2 and MIRA-3 registration trials and MIRA-4 pediatric safety trial for the treatment of RM.
  • Ocuphire previously completed the first Phase 3 registration trial in RM( NCT04620213 ) and Phase 2 trial in presbyopia ( NCT04675151 ).

Eyevensys Enters Collaboration with Phillips-Medisize and Minnetronix Medical

Retrieved on: 
Monday, September 27, 2021
Technology, Medical Devices, Infectious Diseases, Genetics, Clinical Trials, Software, Biotechnology, Hardware, Health, Optical, Geographic atrophy, Business development, Ciliary muscle, Diffuse axonal injury, Neuro, Pulse generator, Solution, European Medicines Agency, IgG4-related ophthalmic disease, Inflammation, DNA, Device, AMD, Patient, Diabetic retinopathy, Electroporation, NIU, Pulse, Business, Eye, Risk management, Plasmid, VEGF, Retinitis pigmentosa, History, Glaucoma, RF, EMA, Pharmaceutical industry, Vaccine, Medical device, Eyevensys, Minnetronix Medical, EYEVENSYS, MINNETRONIX MEDICAL

Alan Wirbisky, Director of Device Development at Eyevensys, said: The opportunity to collaborate with both Minnetronix Medical and Phillips-Medisize is incredibly significant for Eyevensys given the capabilities and experience that the two companies possess.

Key Points: 
  • Alan Wirbisky, Director of Device Development at Eyevensys, said: The opportunity to collaborate with both Minnetronix Medical and Phillips-Medisize is incredibly significant for Eyevensys given the capabilities and experience that the two companies possess.
  • During our 25 year history, we have successfully partnered with many medical startups like Eyevensys to navigate the pitfalls of electromechanical medical device development.
  • Since 1996, Minnetronix Medical has accelerated medical device breakthroughs via design, development and manufacturing services for companies around the world.
  • Minnetronix Medical is based in St. Paul, Minn. More information can be found on the Minnetronix website, by calling 651-917-4060 or emailing [email protected] .

Eyevensys Raises $12M in a Series B Plus Funding Round

Retrieved on: 
Wednesday, August 4, 2021
Health, Genetics, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Wedbush Securities, Korea Investment Partners, Eyevensys, KOREA INVESTMENT PARTNERS, EYEVENSYS

Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announces it has raised $12M in a Series B Plus funding round.

Key Points: 
  • Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announces it has raised $12M in a Series B Plus funding round.
  • Korea Investment Partners is leading the Series B Plus financing and existing investors will also join the round.
  • We're thrilled to announce this funding round, which will help us move forward in our mission to develop life-changing solutions for patients with debilitating eye diseases, said Dr. Patricia Zilliox, CEO of Eyevensys.
  • Wedbush PacGrow acted as the exclusive placement agent for the Series B Plus financing.

Eyevensys Named to French Tech 120 Program

Retrieved on: 
Monday, February 15, 2021
Biotechnology, Pharmaceutical, Health, Ciliary muscle

Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announced it has been accepted into the French Tech 120 program for 2021.

Key Points: 
  • Eyevensys, a privately held, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, today announced it has been accepted into the French Tech 120 program for 2021.
  • This government-backed program, run by La French Tech, offers support for 120 French startups considered late-stage and in a hypergrowth phase.
  • Participants will also benefit from collaboration with the French Tech 120 community, and a needs analysis that will help shape future regulations.
  • The Eyevensys technology turns the eye into a biofactory, allowing the ciliary muscle to produce the therapeutic protein.