Orasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

QLOSI™ is a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials Affecting more than 128 million people in the…

Continue ReadingOrasis Pharmaceuticals Announces FDA Approval of QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia 

- Investigational, novel eye drop candidate was assigned PDUFA goal date of October 22, 2023 Ponte Vedra, FL, February 21, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused…

Continue ReadingFDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia 

Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia

- Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process and affects more than 120 million people in the U.S.…

Continue ReadingOrasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia

Orasis Pharmaceuticals Announces Phase 2b Trial Efficacy and Safety Results of Novel Presbyopia Eye Drop Candidate, CSF-1, at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

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- Two presentations on the Phase 2b clinical trial show CSF-1 met the primary endpoints and achieved statistically significant and clinically meaningful improvements in distance-corrected near visual acuity (DCNVA) for…

Continue ReadingOrasis Pharmaceuticals Announces Phase 2b Trial Efficacy and Safety Results of Novel Presbyopia Eye Drop Candidate, CSF-1, at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

Orasis Pharmaceuticals Announces Positive Phase 3 Topline Results of Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia

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- Phase 3 NEAR-1 and NEAR-2 clinical trials met primary and key secondary endpoints - Presbyopia is the loss of ability to focus on near objects as a result of…

Continue ReadingOrasis Pharmaceuticals Announces Positive Phase 3 Topline Results of Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia

Orasis Pharmaceuticals to Present New Data on Novel Presbyopia Candidate at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

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Herzliya, Israel, April 12, 2022 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced…

Continue ReadingOrasis Pharmaceuticals to Present New Data on Novel Presbyopia Candidate at the 2022 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting