American Academy of Ophthalmology

Clearside Biomedical Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024

ALPHARETTA, Ga., March 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022.
  • Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth quarter of 2022.

Clearside Biomedical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • Other Income: Other income for the third quarter of 2023 was $0.4 million, compared to $0.2 million for the third quarter of 2022.
  • Other Expense: Non-cash interest expense for the third quarter of 2023 was $2.6 million, compared to $1.3 million in the third quarter of 2022.
  • Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023

EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.

Key Points: 
  • EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.
  • Importantly, Annexon also announced that it has achieved target enrollment of 225 patients in the randomized, double-blind, placebo-controlled Phase 3 trial of ANX005 in patients with GBS.
  • Research and development (R&D) expenses: R&D expenses were $27.9 million for the quarter ended September 30, 2023, reflecting the advancement of the company’s priority programs, including GBS, GA and ANX1502, compared to $27.9 million for the quarter ended September 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2023, compared to $8.2 million for the quarter ended September 30, 2022.

Adverum Biotechnologies Reports Third Quarter 2023 Financial Results and Pipeline Highlights

Retrieved on: 
Thursday, November 9, 2023

REDWOOD CITY, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the third quarter ended September 30, 2023.

Key Points: 
  • “In our OPTIC presentation at AAO, we’ve built upon our industry leading dataset in wet AMD gene therapy,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • Scientific Meeting Presentations: In October 2023, Adverum showcased non-clinical data in two presentations at the European Society of Cell and Gene Therapy 2023 Annual Meeting.
  • Stock-based compensation expense included in research and development expenses was $1.2 million for the third quarter of 2023.
  • Stock-based compensation expense included in general and administrative expenses was $3.2 million for the third quarter of 2023.

Tarsus Reports Third Quarter 2023 Financial Results and Recent Business Achievements

Retrieved on: 
Thursday, November 9, 2023

IRVINE, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results for the third quarter ended September 30, 2023, and recent business achievements.

Key Points: 
  • Management to host conference call today, November 9, 2023, at 1:30 p.m. P.T.
  • IRVINE, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results for the third quarter ended September 30, 2023, and recent business achievements.
  • Saturn-2 data were delivered as encore presentations at the American Academy of Optometry and American Academy of Ophthalmology conferences.
  • In the third quarter of 2023:
    The Company’s expansive disease education efforts continue to drive awareness among eye care providers (ECPs) and action in proactively diagnosing DB.

A Key To Healthy Eyes Is UV Protection In Winter Months

Retrieved on: 
Wednesday, November 8, 2023

During the winter months a number of factors increase UV exposure to the eyes, including snow , which may reflect as much as 80 percent of UV radiation, as UV rays are deflected from its surface and into the eyes.

Key Points: 
  • During the winter months a number of factors increase UV exposure to the eyes, including snow , which may reflect as much as 80 percent of UV radiation, as UV rays are deflected from its surface and into the eyes.
  • Also, deciduous trees shed their leaves and offer little shade to reduce UV rays, and even clouds do not block UV light.
  • In winter, the sun is even lower in the sky, and its UV rays travel more directly to the eyes and skin.
  • Finally, in colder climates people may choose to be near a sunny window, and this leads to further UV exposure.

Adverum Biotechnologies Announces 3-Year Efficacy and Safety Results from the OPTIC Extension Study in Patients with Wet AMD at AAO 2023

Retrieved on: 
Saturday, November 4, 2023

A summary of previously announced aflibercept protein levels from the LUNA study was also presented.

Key Points: 
  • A summary of previously announced aflibercept protein levels from the LUNA study was also presented.
  • “These efforts are now supported by the most mature dataset in wet AMD IVT gene therapy, with the OPTIC safety and efficacy data now sustained out to 3 years.
  • We are particularly encouraged by the continuous and consistent aflibercept protein levels observed at up to 4.5 years post-treatment.
  • Taken together, the efficacy and safety at the 2E11 dose in the OPTIC trial underscore Ixo-vec's potential as a promising treatment option for wet AMD patients addressing real-world unmet needs.

SYFOVRE® (pegcetacoplan injection) Continued to Demonstrate Increasing Treatment Effects Over 3 Years in Patients with Geographic Atrophy (GA)

Retrieved on: 
Saturday, November 4, 2023

WALTHAM, Mass., Nov. 04, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced data from the GALE extension study following 3 years of continuous treatment with SYFOVRE® (pegcetacoplan injection), the first-ever FDA-approved treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The data were reported during an oral presentation at the American Academy of Ophthalmology (AAO) Annual Meeting.

Key Points: 
  • “We are continuing to see increasing SYFOVRE treatment effects year-over-year and a more than 40% reduction in nonsubfoveal lesion growth in the third year,” said Caroline Baumal, M.D., chief medical officer, Apellis.
  • “Additionally, SYFOVRE is the only treatment that offers dosing beyond 12 months, and these results demonstrate the importance of early and continuous treatment over time.”
    SYFOVRE continued to demonstrate increasing treatment effects over time.
  • Reduced nonsubfoveal GA lesion growth with both monthly (42%; p
  • Approximately 92% of patients enrolled in GALE completed the first year of the study, demonstrating robust long-term treatment compliance.

New Preliminary Clinical Data on Potential of Opus AAV-based Gene Therapy for Rare Inherited Retinal Disease to be Presented at the American Academy of Ophthalmology Annual Conference 2023

Retrieved on: 
Friday, November 3, 2023

RALEIGH, N.C., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-focused gene therapy company developing treatments for inherited retinal diseases, today announced that preliminary data from a Phase 1/2 clinical trial evaluating the potential of its gene therapy to address Leber congenital amaurosis (LCA) due to mutations in LCA5 will be presented in a symposium at the American Academy of Ophthalmology annual conference held November 3-6 in San Francisco.

Key Points: 
  • RALEIGH, N.C., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-focused gene therapy company developing treatments for inherited retinal diseases, today announced that preliminary data from a Phase 1/2 clinical trial evaluating the potential of its gene therapy to address Leber congenital amaurosis (LCA) due to mutations in LCA5 will be presented in a symposium at the American Academy of Ophthalmology annual conference held November 3-6 in San Francisco.
  • The data will be presented as part of a broader presentation by Tomas S. Aleman, MD, the principal investigator of the trial, focused on gene augmentation therapies for the treatment of inherited retinal degenerations.
  • Details of the presentation are as follows:
    Session: The Future of Retinal Disease Pharmacological, Stem Cell and Gene Therapy Treatments

Clearside Biomedical Announces Presentations at the American Academy of Ophthalmology 2023 Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

ALPHARETTA, Ga., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that multiple oral and poster presentations will be delivered at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting taking place November 3 – 6, 2023 in San Francisco, CA.

Key Points: 
  • ALPHARETTA, Ga., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that multiple oral and poster presentations will be delivered at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting taking place November 3 – 6, 2023 in San Francisco, CA.
  • AAO is the world's largest association of eye physicians and surgeons.
  • Presentations will be delivered by leading physicians on behalf of Clearside and the Company’s commercial and development partners:
    Title: Safety and Tolerability of Suprachoroidal CLS-AX (Axitinib Injectable Suspension) in nAMD Patients in a Phase 1/2A Study, OASIS
    Title: Experience With Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey
    Title: A Phase 2 Trial of Belzupacap Sarotalocan, a Targeted Investigational Therapy for Choroidal Melanoma via Suprachoroidal Administration