OSDI

Bausch + Lomb Announces Statistically Significant Results From a Clinical Study of a Novel Daily Nutritional Supplement for Dry Eyes

Retrieved on: 
星期四, 四月 25, 2024
Science, Other Science, Research, Pharmaceutical, Optical, General Health, Health, Clinical Trials, Lutein, Safety, Bausch & Lomb, D3, Trial of the century, Development, Research and development, Curcumin, Anxiety, Frontiers, OSDI, Ageing

The clinical study met both primary endpoints:

Key Points: 
  • The clinical study met both primary endpoints:
    Change from baseline at day 56 in ocular symptoms measured by OSDI score.
  • The study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time (TBUT), osmolarity, ocular surface health and presence of an inflammatory marker.
  • “More than 150 million people experience dry eyes in the U.S.,” said Yehia Hashad, M.D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb.
  • “This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief.”

Sight Sciences Announces the Publication of Successful Results of the SAHARA Randomized Controlled Clinical Trial Comparing TearCare® to Restasis® for the Treatment of Dry Eye Disease

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星期一, 十二月 18, 2023
Patient, Entrepreneurship, Principal, Ophthalmology, Health, MD, Clinical trial, Inflammation, Randomized controlled trial, Gland, Keratoconjunctivitis, Telecanthus, Medicare, OSDI, Meibomian gland dysfunction, Test management, RCT

“We are extremely pleased to have the successful six-month results of the SAHARA RCT now published in a peer-reviewed journal.

Key Points: 
  • “We are extremely pleased to have the successful six-month results of the SAHARA RCT now published in a peer-reviewed journal.
  • The data from this trial support our belief in the clinical efficacy of interventional eyelid procedures enabled by TearCare technology versus the most commonly prescribed dry eye therapeutic for meibomian gland dysfunction,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences.
  • SAHARA included 345 subjects at 19 sites in 11 states randomized 1:1 to either TearCare or Restasis.
  • TearCare and Restasis also delivered comparable statistically significant clinical improvements in OSDI scores, Symptoms Assessment in Dry Eye (“SANDE”) scores, and Eye Dryness Scores (“EDS”), patient reported outcomes to subjectively assess dry eye severity.

Sight Sciences Announces Presentation of Successful Phase I Results of the SAHARA Randomized Controlled Clinical Trial Comparing TearCare® to Restasis® for the Treatment of Dry Eye Disease at the American Academy of Optometry Annual Meeting

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星期四, 十月 12, 2023
Health, Telecanthus, Inflammation, American Academy, Test management, Gland, Randomized controlled trial, Principal, Clinical trial, Patient, RCT, OSDI, Keratoconjunctivitis, Medical imaging, Pharmaceutical industry, Ciclosporin

These results were presented today at the American Academy of Optometry’s annual meeting in New Orleans.

Key Points: 
  • These results were presented today at the American Academy of Optometry’s annual meeting in New Orleans.
  • “Pharmaceutical intervention with Restasis has been the hallmark of dry eye treatment since its introduction.
  • SAHARA included 345 subjects at 25 sites in 14 states randomized 1:1 between TearCare and Restasis groups.
  • TearCare and Restasis also delivered comparable statistically significant clinical improvements in OSDI scores, Symptoms Assessment in Dry Eye (“SANDE”) scores, and Eye Dryness Scores (“EDS”), patient reported outcomes to subjectively assess dry eye severity.

Sight Sciences Reports Second Quarter 2023 Financial Results and Reaffirms Guidance for Full Year 2023

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星期四, 八月 3, 2023
IOP, Glaucoma, Telecanthus, American Academy, GAAP, Cigna, MIGS, Ophthalmology, Patient, Ciclosporin, Webcast, Growth, OMNI, News, OSDI, Pharmaceutical industry, Video game, Medical imaging

MENLO PARK, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients' lives, today reported financial results for the second quarter ended June 30, 2023 and reaffirmed guidance for full year 2023.

Key Points: 
  • MENLO PARK, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients' lives, today reported financial results for the second quarter ended June 30, 2023 and reaffirmed guidance for full year 2023.
  • Gross profit for the second quarter of 2023 was $20.1 million compared to $14.5 million for the prior year period.
  • Adjusted operating expenses2 were $31.5 million in the second quarter of 2023, down from $33.7 million in the prior year period.
  • Sight Sciences reaffirms revenue guidance expectations for the full year 2023 of $89.0 million to $94.0 million, which represents growth of approximately 25% to 32% compared to 2022.

Sight Sciences Announces Positive Results and Primary Endpoint Successfully Met in SAHARA, a Randomized Controlled Clinical Trial Comparing Interventional Eyelid Procedures Enabled by TearCare® Technology to Restasis¹ for the Treatment of Dry Eye

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星期四, 七月 20, 2023
American Academy of Optometry, RCT, Eye disease, American Academy, Wills Eye Hospital, Gland, OSDI, Telecanthus, Optometry, Patient, Physician, Randomized controlled trial, Entrepreneurship, Principal, Bias, MGD, Pharmaceutical industry, Medical imaging, MD, Ciclosporin

The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease.

Key Points: 
  • The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease.
  • The SAHARA trial also observed that procedures enabled by TearCare were non-inferior to Restasis eyedrops in Ocular Surface Disease Index (OSDI), which was the co-primary six-month endpoint.
  • Symptoms endpoints include two commonly used patient-reported questionnaires: Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE).
  • Sight Sciences designed its TearCare technology and its comprehensive interventional eyelid procedure to safely and effectively treat the underlying obstructive causes of MGD.

Azura Ophthalmics Presents Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction at Ophthalmology Innovation Summit XII

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星期五, 十二月 9, 2022
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Therapy, Baozou Big News Events, M. B, Exocrine gland, Selenium disulfide, Military medicine, Veteran, Diagnosis, Visual Science, Corneal ulcers in animals, Patient, Duane syndrome, Classification, Milner, MGS, OIS, Total, M. A, Drug development, Meibomian gland, News, MGD, European Ophthalmic Pathology Society, All rights reserved, Adverse Events, Luchs, Safety, Investigative Ophthalmology & Visual Science, Systematic review, Contact lens, AES, Prevalence, Pharmaceutical industry, Telescopic sight, Medical device, OSDI, Ophthalmology, Azura, Amit Majmudar

It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.

Key Points: 
  • It was a pleasure to share our exciting Phase 2b results at OIS XII, and we look forward to advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • The results from Azuras Phase 2b study of AZR-MD-001 0.5% in MGD were presented during the Spotlight on Dry Eye session at OIS XII.
  • The Phase 2b trial was a multi-center, double-masked, vehicle-controlled, parallel group study that evaluated the safety and efficacy of AZR-MD-001 in 245 patients with MGD.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

Azura Ophthalmics Announces Positive Results from Phase 2b Clinical Trial of AZR-MD-001 in Meibomian Gland Dysfunction

Retrieved on: 
星期四, 十一月 17, 2022
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Total, Medical director, M. A, Irritation, Exocrine gland, MGS, Safety, Investigative Ophthalmology & Visual Science, Meibomian gland, European Ophthalmic Pathology Society, Veteran, MGD, AES, LASIK, United, Drug development, VAS, All rights reserved, Eyelid, Physician, Pain, Diagnosis, Patient, Duane syndrome, Prevalence, Selenium disulfide, Luchs, Corneal ulcers in animals, Classification, Gland, Military medicine, Therapy, Milner, SPEED, Business, M. B, Systematic review, Adverse Events, Contact lens, Warrenville, Pharmaceutical industry, Medical imaging, Telescopic sight, Medical device, OSDI, Ophthalmology, Amit Majmudar, Azura

Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).

Key Points: 
  • Azura Ophthalmics Ltd. , a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in Meibomian Gland Dysfunction (MGD).
  • We are thrilled to build upon these positive results by advancing AZR-MD-001 to a pivotal Phase 3 clinical trial for MGD in 2023.
  • I look forward to collaborating with the Azura team and my fellow scientific advisory board members to advance AZR-MD-001.
  • Meibomian Gland Dysfunction is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum which can end in gland atrophy.

Sight Sciences Announces Publication of Data Showcasing Superior Symptoms Improvements with the TearCare® System Compared to LipiFlow* in Patients with Advanced Dry Eye Disease (DED)

Retrieved on: 
星期四, 九月 29, 2022
Exocrine gland, Ophthalmology, Disease, OSDI, DED, Patient, Obstruction, Nasdaq, Randomized controlled trial, GLOBE, MGD, Medical imaging

Study authors concluded that the TearCare procedure delivered superior symptoms improvements over LipiFlow in patients suffering from advanced dry eye disease.

Key Points: 
  • Study authors concluded that the TearCare procedure delivered superior symptoms improvements over LipiFlow in patients suffering from advanced dry eye disease.
  • We are encouraged by the superior clinical findings in this subgroup analysis of advanced dry eye patients from the OLYMPIA trial, said Paul Badawi, CEO of Sight Sciences.
  • A comparison of TearCare and LipiFlow systems in reducing dry eye disease symptoms associated with meibomian gland disease.
  • TearCare for the treatment of meibomian gland dysfunction in adult patients with dry eye disease: a masked randomized controlled trial.

Azura Ophthalmics Provides Update on AZR-MD-001 Phase 2 Clinical Program Targeting Meibomian Gland Dysfunction

Retrieved on: 
星期三, 九月 28, 2022
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, Science, Therapy, Safety, Trial of the century, Twitter, FDA, Food, OSDI, AZR, Duane syndrome, IND, LinkedIn, Population, MGS, CLD, Exocrine gland, DED, Selenium disulfide, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, CEO, M. A, Corneal ulcers in animals, Severe cognitive impairment, M. B, Diagnosis, Meibomian gland, Drug development, Investigational New Drug, Milner, Classification, Luchs, Ophthalmic drug administration, MGD, Pharmaceutical industry, Telescopic sight, Medical device, Azura, Ophthalmology, Amit Majmudar

Meibomian Gland Dysfunction is the leading cause of Dry Eye Disease and Contact Lens Discomfort impacting millions of people in the U.S. alone, said Marc Gleeson, CEO of Azura Ophthalmics.

Key Points: 
  • Meibomian Gland Dysfunction is the leading cause of Dry Eye Disease and Contact Lens Discomfort impacting millions of people in the U.S. alone, said Marc Gleeson, CEO of Azura Ophthalmics.
  • Azura is currently conducting a multi-center, double-masked, vehicle-controlled Phase 2b study that will evaluate the safety and efficacy of AZR-MD-001 in patients with MGD.
  • The ongoing study builds upon previous findings from a successful Phase 2a clinical trial evaluating AZR-MD-001 in the same patient population.
  • Meibomian Gland Dysfunction (MGD) is a chronic and progressive condition associated with blockage of the meibomian glands and alteration in the quality of expressed meibum.

Sight Sciences Announces Completion of Enrollment in SAHARA, a Randomized Clinical Trial of the TearCare® System vs Restasis®

Retrieved on: 
星期二, 九月 13, 2022
Adult, Industry, Patient, Clinical trial, U.S. Securities and Exchange Commission, Phase transition, Nasdaq, Eye, RCT, Risk, Time, COVID-19, OSDI, Entrepreneurship, Securities Act of 1933, Conditional sentence, Company, Growth, Intellectual property, Heat, FDA, Duane syndrome, Health, Tax Cuts and Jobs Act of 2017, Forward-looking statement, MIGS, ECP, CEO, Regulation, Severe cognitive impairment, Jumpstart Our Business Startups Act, GLOBE, Intraocular pressure, MGD, Securities Exchange Act of 1934, Eyelid, JOBS, Private Securities Litigation Reform Act, Exocrine gland, Wills Eye Hospital, Randomized controlled trial, Pharmaceutical industry, Medical device, Ciclosporin

Results from the 310-patient, 1:1 randomized SAHARA trial are expected to be available in late Q2 2023.

Key Points: 
  • Results from the 310-patient, 1:1 randomized SAHARA trial are expected to be available in late Q2 2023.
  • SAHARA is the first multicenter, randomized controlled trial designed to evaluate whether treatment with a dry eye therapeutic device (TearCare) demonstrates superiority when randomized against a standard of care dry eye prescription topical medication (Restasis).
  • Patients in the Restasis control group self-administered 1 drop of Restasis twice a day every day for 6 months with clinical assessments completed at the 6-month timepoint.
  • Following the 6-month read-out, all Restasis patients will be crossed over to the TearCare group and receive a TearCare procedure.