Southern Gal
1 month ago
MENLO PARK, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the “Company”), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, today announced the publication of the twelve-month results from the SAHARA trial.
Patients previously treated with Restasis® (cyclosporine ophthalmic emulsion 0.05%) prescription eyedrops (“Restasis”) had additional clinically meaningful improvements in the signs and symptoms of dry eye disease (“DED”) when crossed over to TearCare. These improvements persisted for six months through month twelve without continued Restasis use.
“Phase 2 of the RCT again demonstrates the clinical effectiveness of TearCare. It also shows that effectiveness appears to be the same whether or not a patient has had prior treatment with Restasis, demonstrating that similar results could be expected when TearCare is used as a primary or secondary treatment for DED,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences.
Phase 1 of the SAHARA RCT included 345 subjects at 19 sites in 11 states randomized 1:1 to either TearCare or Restasis1. In Phase 2 of the SAHARA RCT, 163 patients who had been randomized and treated with Restasis during phase 1 were crossed over to TearCare at the six-month visit and followed for six months through Month 12 of the study.
Data from the first six months of the SAHARA RCT demonstrated that TearCare, an interventional eyelid procedure for DED, was superior at all measured time points to twice daily use of Restasis for the improvement of tear break up time (“TBUT”), the trial’s primary dry eye signs endpoint and a key measure of tear stability1. TearCare was superior to Restasis in multiple other objective measures of dry eye, and demonstrated clinically meaningful improvements in several symptoms that matched or surpassed Restasis at all measured time points.
The aim of phase 2, undertaken in months six through twelve, was to demonstrate that cessation of Restasis followed by a single TearCare procedure would result in improved signs and symptoms for patients beyond what was achieved with six months of Restasis.
Southern Gal
1 month ago
MENLO PARK, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients' lives, today announced the results as published in the journal Clinical Ophthalmology of a new analysis of the ROMEO (Retrospective, Observational, Multicenter Evaluation of OMNI) study data. This new analysis evaluated the association between the severity of glaucoma and the intraocular pressure ("IOP") and medication outcomes for patients treated with the OMNI Surgical System ("OMNI"). OMNI enables a procedure intended to restore aqueous outflow of glaucomatous eyes by addressing the three areas of outflow resistance associated with the disease.
The findings suggest that ab interno canaloplasty coupled with trabeculotomy using OMNI was as effective at lowering IOP and reducing medication usage in advanced glaucoma patients as it was in mild and moderate glaucoma patients. This data challenges the belief that advanced disease stage is a barrier to successful treatment outcomes for minimally invasive glaucoma surgery ("MIGS").
"There had been some debate about the efficacy of MIGS in advanced glaucoma patients, with speculation that prolonged disease may cause irreversible harm to the distal outflow pathway," said Dr. Jaime E. Dickerson, Jr., Vice President of Medical and Clinical Affairs at Sight Sciences. "The current study suggests that treatment with OMNI technology, which has a strong safety profile and proven durability, is still effective in patients with more extensive visual field damage."
ROMEO was an Institutional Review Board ("IRB") approved retrospective case series conducted at eleven ophthalmology practices in the United States. Participants were mainly primary open-angle glaucoma patients (122 of 129, or 95%) who had undergone the implant-free OMNI procedure, which has been cleared by the FDA for canaloplasty followed by ab interno trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma, either combined with cataract surgery or as a standalone procedure.
Eyes were categorized based on visual field mean deviation ("MD"), with participants assigned to a group with severity rated as mild (n=79, median MD -2.7 dB), moderate (n=42, median MD -8.0 dB) or advanced (n=6, median MD -13.3). The study compared outcomes at 12 months.
Key findings reported in the study include:
Significant reductions in both IOP and IOP-reducing medications were observed.
The majority of eyes (70%) experienced a reduction in IOP at Month 12, with most achieving levels of 18 mmHg or less (92%).
The percentage of IOP reduction was consistent across severity groups, with month 12 mean IOP ranging between 14 mmHg and 16 mmHg.
Medication reductions were observed across all severity groups, with the majority of patients showing a reduction of at least 1 medication (50% to 69%), indicating the effectiveness of the treatment approach.
Regression analysis found no significant relationship between month 12 IOP and visual field loss, suggesting treatment outcomes were consistent irrespective of disease severity.
"Clinical trials and real-world results continue to demonstrate favorable OMNI treatment outcomes across different stages of glaucoma," said Paul Badawi, Co-Founder and CEO of Sight Sciences. "These findings reinforce our dedication to offering effective treatment options for glaucoma patients at every stage of the disease and also fuel our initiatives to continue reimagining eyecare with transformative technology and an interventional mindset."
Southern Gal
3 months ago
Jury selection begins pretty soon between Alcon and sight sciences. SGHT has very good sales and clinically proven efficacy. Seems to me that the quickest fix for Alcon’s problems is to buy sight sciences, lock, stock, and barrel. Alcon gets two great products and whatever sight sciences has in development. Perhaps most importantly, an acquisition makes Alcon's legal problems go away. Alcon's is looking at huge retroactive and ongoing royalties due to Sight Sciences, if the jury decides against Alcon.
Southern Gal
3 months ago
“Long-term data is key in the selection of a surgical treatment,” said Arkadiy Yadgarov, MD, of Omni Eye Services of Atlanta, GA. “The 12-month GEMINI trial demonstrated efficacy of the OMNI procedure combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma.1,2 This extension of the trial shows that these positive 12-month outcomes were sustained through 36 months.”
Southern Gal
7 months ago
Up .20 premarket
Staffan Encrantz, an insider of Sight Sciences, Inc., recently acquired 521,855 shares of the company. The buys took place at prices ranging from $3.09 to $3.46 per share, on dates ranging from November 24 to November 28, 2023. Encrantz now owns 6,074,526