Keratopathy

Oyster Point Pharma, Inc., Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Monday, August 2, 2021
Health sciences, Medicine, Health care, Smoking cessation, Nose, Benzazepines, Varenicline, Nasal spray, Medication, Oyster, Keratopathy

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.

Key Points: 
  • Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
  • Oyster Point Pharmas lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, being developed as a preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy.
  • In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease.
  • Oyster Point continues to expand its research and development pipeline through internal innovation and external collaborations with a goal to bring transformative therapies to patients and the eye care providers that take care of them.

RegeneRx JV Updates RGN-259 Regulatory Progress for Dry Eye Syndrome

Retrieved on: 
Wednesday, July 14, 2021
Health sciences, Health, Food and Drug Administration, Clinical research, Design of experiments, Keratopathy, Clinical trial

As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting.

Key Points: 
  • As previously reported, ReGenTree is working with a 3rd party FDA consulting firm to complete a regulatory gap analysis and explore the prospects of a pre-BLA meeting.
  • This includes a review of clinical studies, non-clinical studies, CMC requirements and previous meeting minutes between ReGenTree and FDA.
  • Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.
  • In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology.

RegeneRx Joint Venture Reports Positive Results from ARISE-3 Clinical Trial Using RGN-259 to Treat Dry Eye Syndrome

Retrieved on: 
Friday, May 14, 2021
Health sciences, Clinical research, Design of experiments, Health, Keratopathy, Forward-looking statement, Phase 3, Clinical trial, Ophthalmology, Medical research

Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.

Key Points: 
  • Thus far, ReGenTree has sponsored three Phase 3 studies in the U.S. for dry eye, which are ARISE-1 (Phase 2b/3), ARISE-2 (Phase 3), and the recently completed ARISE-3 (Phase 3) for dry eye.
  • In addition to dry eye, the Company completed a Phase 3 study (SEER-1) for neurotrophic keratopathy (NK), an orphan indication in ophthalmology.
  • Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.
  • Moreover, there is no guarantee any clinical trial will be successful or confirm previous clinical results.

Oyster Point Pharma Announces Clinical Data Presentation of OC-01 (varenicline) Nasal Spray for Dry Eye Disease at the Association for Research in Vision and Ophthalmology 2021 Virtual Annual Meeting

Retrieved on: 
Saturday, May 1, 2021
Benzazepines, Smoking cessation, Varenicline, Keratopathy, Cornea

Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins.

Key Points: 
  • Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins.
  • This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea.
  • OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country.
  • Oyster Point Pharma\xe2\x80\x99s lead product candidate, OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy.

RegeneRx Partner Receives Patent for New Ophthalmic Formulation of Thymosin Beta 4

Retrieved on: 
Thursday, May 16, 2019
Branches of biology, Organ systems, Animal anatomy, Beta thymosins, Thymosin, Ophthalmic, Eye drop, Keratopathy, Tears, Neurotrophic factors, Thymosin beta-4

"We are pleased that Gtree has been granted another patent related to T4 in the ophthalmic field emanating from its comprehensive development of RGN-259, our sterile, preservative-free eye drop solution.

Key Points: 
  • "We are pleased that Gtree has been granted another patent related to T4 in the ophthalmic field emanating from its comprehensive development of RGN-259, our sterile, preservative-free eye drop solution.
  • RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids.
  • RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (T4) and its constituent fragments, for tissue and organ protection, repair and regeneration.
  • RGN-259, the Company's ophthalmic eye drop, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy.

First Patient Enrolled in RegeneRx JV Phase 3 Dry Eye Trial

Retrieved on: 
Monday, May 13, 2019
Ophthalmology, Medicine, Health, Ophthalmic, Dry eye syndrome, Eye drop, Keratopathy, Placebo

The clinical trial will evaluate RGN-259, a sterile, preservative-free eye drop in 700 patients with dry eye syndrome (DES) at approximatelyfifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology,comparing the drug candidate to placebo.

Key Points: 
  • The clinical trial will evaluate RGN-259, a sterile, preservative-free eye drop in 700 patients with dry eye syndrome (DES) at approximatelyfifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology,comparing the drug candidate to placebo.
  • This is a critical trial for us and our partner, which we believe, if successful, should significantly enhance the value of RegeneRx.
  • Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye.
  • RGN-259, the Company's ophthalmic eye drop, is currently in Phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy.

ReGenTree Presents Results of a Comparison Study of RGN-259 and Approved Prescription Drugs for Dry Eye Syndrome in a Mouse Model at ARVO

Retrieved on: 
Wednesday, May 2, 2018
Ophthalmology, RTT, Anatomy, Dry eye syndrome, Goblet cell, Cornea, Keratopathy

The study found that RGN-259 treatment promoted recovery of mucins and goblet cells, improved corneal integrity, increased tears, and reduced inflammation in a dry eye mouse model.

Key Points: 
  • The study found that RGN-259 treatment promoted recovery of mucins and goblet cells, improved corneal integrity, increased tears, and reduced inflammation in a dry eye mouse model.
  • RGN-259 has also demonstrated a strong safety profile with fewer side effects compared to approved products currently on the market.
  • Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships.
  • In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology.