Optical

Drug Farm Receives Rare Pediatric Disease Designation from the U.S. FDA for DF-003 to Treat ROSAH Syndrome

Retrieved on: 
Saturday, January 13, 2024

Drug Farm , a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s alpha-kinase 1 (ALPK1) inhibitor, DF-003, to treat patients with ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) Syndrome.

Key Points: 
  • Drug Farm , a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s alpha-kinase 1 (ALPK1) inhibitor, DF-003, to treat patients with ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) Syndrome.
  • DF-003 is currently being evaluated in a Phase 1 trial ( NCT05997641 ) to assess safety and pharmacokinetics in normal healthy volunteers.
  • “Pediatric patients living with ROSAH Syndrome face a significant unmet need with limited options to treat vision loss,” said Jeysen Yogaratnam, Chief Medical Officer, Drug Farm.
  • “Obtaining Rare Pediatric Disease Designation recognizes the serious and debilitating complications of this rare disease and upholds our goal to provide DF-003 as the first targeted drug for potential treatment in patients afflicted with ROSAH Syndrome.”

Harrow Announces Availability of VEVYE® (Cyclosporine Ophthalmic Solution) 0.1%, the First and Only Cyclosporine-Based Product Indicated for Treating Both Signs and Symptoms of Dry Eye Disease

Retrieved on: 
Thursday, January 11, 2024

VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).

Key Points: 
  • VEVYE, uniquely dispensed in a 10 microliter drop, is the first and only cyclosporine‑based product indicated for treating both the signs and symptoms of dry eye disease (DED).
  • In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are thrilled to announce the availability of VEVYE for our customers and their patients.
  • VEVYE is powered by the unique combination of the reliable and trusted active ingredient, cyclosporine, and a water-free semifluorinated alkane delivery vehicle, perfluorobutylpentane.
  • In addition, 92% of this patient population remains un- or under-treated due to limited efficacy and poor tolerability of existing prescription and non-prescription choices.4

RealWear Ships Most Advanced Rugged Enterprise Intrinsically Safe Smart Glasses, Readying Industrial Customers for AI Revolution

Retrieved on: 
Tuesday, January 9, 2024

RealWear received its official ATEX / IECEx Intrinsically Safe (IS) certification for RealWear Navigator Z1 (“Navigator Z1”), with consultation with i.safe MOBILE, a technology expert in IS product development. IS certification is granted after passing a plethora of tests (i.e. thermal, electrical integrity, mechanical durability, safety compliance, and explosion-proof testing), validating that the device, whose purpose is to boost productivity and enhance safety for frontline workers, will not cause an explosion where flammable particulates are present in the atmosphere. All consumer electronics that are typically deployed for worker productivity in a standard office environment--including iPhones, tablets, and immersive AR/VR headsets--are strictly prohibited in these zones.

Key Points: 
  • (CES) –RealWear, Inc., the pioneer of smart glasses for frontline workers, today announced at the Consumer Electronics Show (CES) that RealWear Navigator® Z1 ( play video ), the world’s most advanced intrinsically safe (IS) head-mounted wearable, starts shipping today.
  • View the full release here: https://www.businesswire.com/news/home/20240109936948/en/
    RealWear Navigator Z1 is the world's most advanced hands-free intrinsically safe ATEX C1D1 smart glasses paving the way for AI for industrial workers.
  • (Photo: Business Wire)
    RealWear received its official ATEX / IECEx Intrinsically Safe (IS) certification for RealWear Navigator Z1 (“Navigator Z1”), with consultation with i.safe MOBILE , a technology expert in IS product development.
  • Navigator Z1 is powered by an advanced Qualcomm SnapDragon 6490 chipset with a built-in advanced AI engine.

NovaBay Pharmaceuticals and Sonoma Pharmaceuticals Agree to Market Avenova-branded Products in the European Union Through Sonoma’s Extensive Distributor Network

Retrieved on: 
Tuesday, January 9, 2024

NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA) today announced an agreement for the sale and marketing of Avenova®-branded products by Sonoma in the European Union.

Key Points: 
  • NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA) today announced an agreement for the sale and marketing of Avenova®-branded products by Sonoma in the European Union.
  • This agreement brings together NovaBay’s deep knowledge of eye care reflected in its Avenova brand with Sonoma’s expertise in distributing hypochlorous acid products overseas.
  • “Sonoma has built a strong and growing presence in the European Union through a network of distributors and direct sales.
  • “The EU market is comparable in size to the U.S., giving NovaBay the opportunity to double its sales of Avenova.

Glaukos Announces Preliminary, Unaudited Fourth Quarter and Full Year 2023 Net Sales and Reaffirms 2024 Revenue Guidance

Retrieved on: 
Tuesday, January 9, 2024

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced its preliminary, unaudited net sales for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced its preliminary, unaudited net sales for the fourth quarter and full year ended December 31, 2023.
  • Preliminary and unaudited total net sales for the fourth quarter and full year of 2023 are expected to be in excess of $81 million and $313 million, respectively.
  • In addition, the company reaffirms its 2024 net sales guidance range of $350 million to $360 million.

Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye

Retrieved on: 
Tuesday, January 9, 2024

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED).

Key Points: 
  • Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED).
  • These data are consistent with the proposed mechanism of action of AR-15512.
  • “We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide Eye Care Professionals (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” said David Endicott, CEO of Alcon.
  • “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.”
    AR-15512 represents an opportunity to bring relief to dry eye sufferers.

Aviceda Announces First Patient Enrolled in Phase 2 GLYCO Clinical Trial Evaluating AVD-104 for the Treatment of Diabetic Macular Edema

Retrieved on: 
Tuesday, January 9, 2024

Aviceda Therapeutics , a private clinical-stage biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced today that they have enrolled the first patient in the GLYCO Phase 2 U.S. clinical trial evaluating their lead ophthalmic candidate AVD-104 for the management of diabetic macular edema (DME).

Key Points: 
  • Aviceda Therapeutics , a private clinical-stage biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced today that they have enrolled the first patient in the GLYCO Phase 2 U.S. clinical trial evaluating their lead ophthalmic candidate AVD-104 for the management of diabetic macular edema (DME).
  • This multi-center, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up.
  • Secondary endpoint analyses will include standard evaluations of treatment efficacy, including macular thickness and vision.
  • Further exploratory variables will include the potential effect of AVD-104 on macular ischemia.

Bifrost Biosystems Launches with Novel Optical Pooled Screening Technology to Power Efficient Discovery

Retrieved on: 
Tuesday, January 9, 2024

Bifrost Biosystems announced today its launch with a vision to power efficient drug discovery through its novel automated Optical Pooled Screening (OPS) platform.

Key Points: 
  • Bifrost Biosystems announced today its launch with a vision to power efficient drug discovery through its novel automated Optical Pooled Screening (OPS) platform.
  • The Bifrost OPS platform uniquely integrates rich, image-based, single-cell profiling data with genome-wide CRISPR perturbations.
  • Through advanced software analysis and machine learning/artificial intelligence algorithms, the platform provides actionable, high-quality information to direct next steps in the discovery process.
  • “Bifrost's cutting-edge technology aims to mitigate these challenges by providing drug developers with significantly more high-quality information in the early stages of drug discovery.

Zenni Optical Eyes Blazing Fast Search with Algolia

Retrieved on: 
Tuesday, January 9, 2024

Zenni chose the Algolia AI Search platform to revolutionize its customer experience and elevate its position as a leading destination for online prescription eyewear.

Key Points: 
  • Zenni chose the Algolia AI Search platform to revolutionize its customer experience and elevate its position as a leading destination for online prescription eyewear.
  • David Ting, CTO and General Manager at Zenni Optical, expressed his enthusiasm for the selection: “Once we went into full production with Algolia, we saw Zenni's search revenue increase by 34%.
  • Algolia’s AI Search platform understands and simplifies these synonyms and improves results automatically.”
    Michelle Adams, Chief Revenue Officer, Algolia said: “Zenni Optical has experienced a transformative impact with Algolia’s AI Search platform, serving as a catalyst to enhance their customer experience and drive significant business results.
  • David Ting, CTO and General Manager at Zenni Optical will also be attending NRF at the Algolia booth #4146.

STAAR Surgical Announces Preliminary Results for Fourth Quarter and Fiscal 2023

Retrieved on: 
Monday, January 8, 2024

STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL) for myopia, astigmatism and presbyopia, today announced preliminary results for the fourth quarter and fiscal year ended December 29, 2023.

Key Points: 
  • STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL) for myopia, astigmatism and presbyopia, today announced preliminary results for the fourth quarter and fiscal year ended December 29, 2023.
  • Preliminary net sales were approximately $76.5 million for the fourth quarter and approximately $322.5 million for fiscal 2023.
  • Operating margin is expected to be approximately 5% for the fourth quarter and fiscal 2023.
  • “Fiscal 2023 was a year of positive market share gains, sales growth and continued profitability for STAAR.