Minimisation

Oculis Announces First Patient First Visit in Phase 3 OPTIMIZE-2 Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery

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星期三, 十二月 20, 2023
Inflammation, FDA, Pain, Patient, Food, Minimisation, OCS, Pharmaceutical industry

Data from the Phase 3 OPTIMIZE-2 trial is intended to support the Company’s NDA submission to the Food and Drug Administration (FDA).

Key Points: 
  • Data from the Phase 3 OPTIMIZE-2 trial is intended to support the Company’s NDA submission to the Food and Drug Administration (FDA).
  • If approved, OCS-01 has the potential to be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.
  • The OPTIMIZE-2 (Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) is a multi-center, randomized, double-masked, vehicle-controlled Phase 3 trial evaluating OCS-01 for the treatment of inflammation and pain following cataract surgery.
  • Similar to the OPTIMIZE-1 trial, patients in the second Phase 3 OPTIMIZE-2 trial will be treated with once-daily OCS-01 post-cataract surgery versus vehicle for 2 weeks.

Longboard Pharmaceuticals’ Presence at American Epilepsy Society (AES) Annual Meeting Reinforces Ongoing Commitment to the Rare Epilepsy Community

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星期二, 十一月 21, 2023
Research, Neurology, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Organization, Treatment, Epilepsy, Minimisation, Pacific studies, Seizure, Polypharmacy, Patient, Medication, CYP, DSM-IV codes, AES, Pharmaceutical industry

Longboard will also host a scientific exhibit with members of its leadership team to highlight details of the ongoing PACIFIC study, and to discuss LP352 as a potential best-in-class therapy for people living with rare seizure disorders.

Key Points: 
  • Longboard will also host a scientific exhibit with members of its leadership team to highlight details of the ongoing PACIFIC study, and to discuss LP352 as a potential best-in-class therapy for people living with rare seizure disorders.
  • “We believe that LP352 has the promise to be a best-in-class therapy for a broad range of DEEs, and we remain committed to moving the space forward.
  • We look forward to presenting new posters and hosting a scientific exhibit to highlight the differentiating qualities of LP352 and our unique development plan.
  • I am also pleased to continue our work with key advocacy organizations, including participation in the Rare Epilepsy Network’s panel: Clustering Rare Epilepsies for Research, Trials & Care,” stated Dr. Randall Kaye, Longboard’s Chief Medical Officer.

OCS-01, First Investigational Eye Drop for Front and Back of the Eye, Met Both Primary Endpoints in Phase 3 OPTIMIZE Trial with a Once Daily Regimen for the Treatment of Inflammation and Pain Following Cataract Surgery

Retrieved on: 
星期二, 八月 8, 2023
Inflammation, Pain, DME, Diabetic retinopathy, Minimisation, OCS, Dexamethasone, Patient, Dentistry

OPTIMIZE results in reduction of inflammation and pain and safety observations were consistent with those observed in the Phase 2 SKYGGN trial with once daily administration.

Key Points: 
  • OPTIMIZE results in reduction of inflammation and pain and safety observations were consistent with those observed in the Phase 2 SKYGGN trial with once daily administration.
  • In the SKYGGN trial, the same two hierarchical primary efficacy endpoints were also met with robust statistical significance and with similar numerical values.
  • This is significant for patients who have undergone cataract surgery, as they currently need to self-administer multiple daily doses of eye drops to alleviate inflammation and pain.
  • We are on track to advance OCS-01 for inflammation and pain following ocular surgery towards an NDA submission with FDA.

Arkose Labs Adds Advanced Phishing Protection to Its Industry-Leading Bot Management Platform, Arkose Bot Manager

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星期四, 四月 20, 2023
Cyberattack, MFA, CDN, Use, Arkose, Internet, URL, Ease, SMS, OTP, PIN, Proxy, FBI, Likelihood function, Minimisation, IC3, Mitigation, ROI, SDK, Economics, Arms industry, Cryptocurrency, Online shopping, G2

Arkose Bot Manager is the evolution of the industry-leading Arkose platform, with phishing protection, CDN integration, and recently announced email intelligence features.

Key Points: 
  • Arkose Bot Manager is the evolution of the industry-leading Arkose platform, with phishing protection, CDN integration, and recently announced email intelligence features.
  • Arkose Bot Manager is the only bot management solution backed by two separate $1 million warranties.
  • The Spring 2023 G2 Grid® Report for Bot Detection and Mitigation rated Arkose Labs with over 98 percent customer satisfaction in every category.
  • Arkose Bot Manager received the highest ratings among its competitors for Ease of Use, Ease of Setup, Ease of Admin, and Likelihood to Recommend.

Oculis Completes Enrollment in Phase 3 OCS-01 OPTIMIZE Trial

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星期四, 三月 16, 2023
Society, DME, Health, Therapy, Annual general meeting, Eye, Refractive surgery, Cerebral edema, Patient, Minimisation, Bangladesh Technical Education Board, Inflammation, Dexamethasone, Cataract, Diabetic retinopathy, NIH, OCS, Retina, American Society of Cataract and Refractive Surgery, CME, Confusion, Safety, ASCRS, Clinical Therapeutics, Dentistry, Pharmaceutical industry, Orbicularis oculi muscle, Pain

Completed enrollment in Phase 3 OPTIMIZE trial brings OCS-01 one step further on the regulatory path to approval.

Key Points: 
  • Completed enrollment in Phase 3 OPTIMIZE trial brings OCS-01 one step further on the regulatory path to approval.
  • The OPTIMIZE (Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) trial is a randomized, double-blind, placebo-controlled Phase 3 trial in 25 participating sites across the US, with 240 patients.
  • The once-a-day data from the trial demonstrated that OCS-01’s unique formulation may allow for effective and safe once a day dosing.
  • Riad Sherif MD, CEO of Oculis, said: “Oculis has taken a material step forward in advancing OCS-01’s Phase 3 clinical trial and I wish to congratulate everyone involved.

Oculis Announces First Patient Enrolled in Phase 3 OPTIMIZE Trial of OCS-01 in the Treatment of Inflammation and Pain Following Cataract Surgery

Retrieved on: 
星期三, 六月 29, 2022
Trustee, Cataract, Retinal, Patient, Refractive surgery, CEO, Annual general meeting, DME, Ophthalmology, Retina, Disease, ASCRS, Pain, Inflammation, U.S. FDA, American Society of Cataract and Refractive Surgery, Dexamethasone, Minimisation, Safety, Society, Geisel School of Medicine, Pharmaceutical industry, Pecten oculi

In the completed Phase 2 SKYGGN study, once-daily OCS-01 successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery.

Key Points: 
  • In the completed Phase 2 SKYGGN study, once-daily OCS-01 successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery.
  • Positive data from that trial was presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting.
  • Oculis subsequently held a positive end-of-Phase 2 meeting with U.S. FDA which enabled the start of the Phase 3 OPTIMIZE trial.
  • Treatment of inflammation and pain following ocular surgery is another indication being pursued for OCS-01, following the commencement in November 2021 of the Phase 3 DIAMOND trial investigating OCS-01 in patients with DME.

Oculis Announces First Patient Enrolled in Phase 3 OPTIMIZE Trial of OCS-01 in the Treatment of Inflammation and Pain Following Cataract Surgery

Retrieved on: 
星期三, 六月 29, 2022
Trustee, FDA, Cataract, Retinal, Patient, Refractive surgery, CEO, Annual general meeting, DME, Ophthalmology, Retina, Disease, ASCRS, Pain, Inflammation, American Society of Cataract and Refractive Surgery, Dexamethasone, Minimisation, Safety, Society, Geisel School of Medicine, Pharmaceutical industry, Pecten oculi

In the completed Phase 2 SKYGGN study, once-daily OCS-01successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery.

Key Points: 
  • In the completed Phase 2 SKYGGN study, once-daily OCS-01successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery.
  • Positive data from that trial was presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting.Oculis subsequently held a positive end-of-Phase 2 meeting with U.S. FDAwhich enabledthe start of the Phase 3 OPTIMIZE trial.
  • Treatment of inflammation and pain following ocular surgery is another indication being pursued for OCS-01, following the commencement in November 2021 of the Phase 3 DIAMOND trial investigating OCS-01 in patients with DME.
  • clinical professor of ophthalmology at New York University and Trustee of Dartmouth Medical School, said: Following cataract surgery, patients often need to self-administer eye drops several times a day to manage inflammation and pain.

Wasabi Wallet Promises More Privacy for Less with the Release of Wasabi Wallet 2.0

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星期五, 六月 17, 2022
Bitcoin, Privacy, BTC, Tor, PSBT, Minimisation, SD, Mac, GLOBE, Color, Communication, Linux, Wabi-sabi, Cryptocurrency, Ledger, Microsoft Windows, Wasabi

Wasabi Wallet 1.0 users can upgrade to the 2.0 version and use the same credentials to access their wallets.

Key Points: 
  • Wasabi Wallet 1.0 users can upgrade to the 2.0 version and use the same credentials to access their wallets.
  • The Wasabi Wallet 2.0 home page now displays the users balance, the privacy progress, the current exchange rate (BTC/USD) and the transaction history list.
  • Although you start with an empty wallet, giving you a privacy progress of 100%, this number is reduced to 0% when you send some Bitcoin to the wallet.
  • Instead, you can create a new wallet and send the coins you want to coinjoin directly to that wallet.