Diabetic retinopathy

EyePoint Pharmaceuticals Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Developments

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onsdag, maj 8, 2024
Science, FDA, AMD, Investment, DOI, Safety, OIS, Stuart, Florida, Food, Research, Cleveland Clinic, Growth, FACS, KOL, Therapy, Thomas Jefferson University, Eye, Wills Eye Hospital, Marketing, DME, Clinical trial, Associate, Diabetic retinopathy, ARVO, Plasma, Uveitis, Pharmaceutical industry

WATERTOWN, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the first quarter ended March 31, 2024, and highlighted recent corporate developments.

Key Points: 
  • The Company plans to provide an update on the path forward for DURAVYU as a potential treatment in NPDR following a review of the full 12-month data in the third quarter of 2024.
  • EyePoint plans to host an R&D Day on June 26, 2024 in New York City.
  • Net product revenue for the first quarter was $0.7 million, compared to net product revenues for the first quarter ended March 31, 2023 of $7.4 million.
  • Operating expenses for the first quarter ended March 31, 2024 totaled $45.0 million versus $29.2 million in the prior year period.

Therini Bio Announces Positive Preclinical Data Supporting the Development of THN391 in Neurodegenerative Ocular Diseases

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onsdag, maj 8, 2024
AMD, Blood, Research, Diabetic retinopathy, Diabetes, Half-life, Disease, STZ, Patient, Macrophage, Hypertension, Macular degeneration, DME, Ageing, Permeability, Annual general meeting, VEGF, ARVO, DR

SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases. The data was detailed in a poster presented by Aaron Kantor, Ph.D., Head of Translational Sciences at Therini Bio, at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle, WA, on May 7, 2024.

Key Points: 
  • SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases.
  • Therini Bio has developed a potential first-in-class therapeutic monoclonal antibody, THN391, that is designed to selectively block fibrin-mediated neuroinflammation without interfering with fibrin’s coagulation properties.
  • In preclinical models of macular degeneration and diabetic retinopathy, THN391 and its analogs demonstrated effectiveness in protecting against vascular and neuronal degeneration.
  • “We are very encouraged by our data demonstrating the effectiveness of THN391 in rodent models of neurodegenerative ocular diseases,” said Joel Naor, M.D., Chief Medical Officer - Ophthalmology at Therini Bio.

Oculis Announces Completion of Enrollment in Phase 2 Randomized Controlled ACUITY Trial with OCS-05 for Acute Optic Neuritis

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onsdag, maj 8, 2024
Neuroprotection, Inflammation, Hospital, Safety, OCS, Diabetic retinopathy, Apoptosis, Optic neuritis, AON, IND, Disease, Patient, Paratriathlon, Geographic atrophy, Optic nerve, Neuron, Glaucoma, Ophthalmology, Neuro, Pharmaceutical industry

The Phase 2 ACUITY study is evaluating once-daily OCS-05 intravenous infusion in patients with AON.

Key Points: 
  • The Phase 2 ACUITY study is evaluating once-daily OCS-05 intravenous infusion in patients with AON.
  • OCS-05 has been granted orphan drug designation in both the United States and Europe, highlighting the importance of this unmet medical need.
  • In the meantime, we keep on working towards an IND submission for OCS-05 in the U.S. in 2024.
  • While corticosteroids are used to shorten the attack, there is no approved therapy for AON and unmet needs remain for therapies that can prevent vision loss after an acute episode of optic neuritis.

Ocular Therapeutix™ Reports First Quarter 2024 Results

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tisdag, maj 7, 2024
AMD, FDA, Barings LLC, Diabetic retinopathy, Research, Webcast, Patient, Eye, Marketing, Quality of life, Glaucoma, Pharmaceutical industry

BEDFORD, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • “Ocular’s excellent progress in 2024 has put the Company on track to becoming a leading retinal care company.
  • First Quarter Ended March 31, 2024, Financial Results
    Total cash and cash equivalents were $482.9 million as of March 31, 2024.
  • Selling and marketing expenses were $10.2 million in the first quarter of 2024, as compared to $10.8 million for the comparable quarter of 2023, primarily reflecting a decrease in professional fees and a reduction in personnel costs.
  • General and administrative expenses were $14.1 million for the first quarter of 2024 versus $9.1 million in the comparable quarter of 2023, higher primarily due to an increase in personnel-related costs and other expenses.

Ocular Therapeutix Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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tisdag, maj 7, 2024
Diabetic retinopathy, Compensated emancipation, Quality of life, Eye, Employment

The awards were approved by the Compensation Committee of Ocular and were made as inducements material to each individual’s acceptance of employment with Ocular under Ocular’s 2019 Inducement Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The awards were approved by the Compensation Committee of Ocular and were made as inducements material to each individual’s acceptance of employment with Ocular under Ocular’s 2019 Inducement Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Mr. Cai’s inducement awards were granted effective as of April 30, 2024, and Dr. Tang’s inducement awards will be granted effective as of May 7, 2024.
  • Each restricted stock unit award is scheduled to vest over three years, in equal annual installments, beginning on May 6, 2024, and subject to the recipient’s continued service to Ocular through the applicable vesting dates.
  • The inducement equity awards are subject to the terms and conditions of the award agreements covering the grants and Ocular’s 2019 Inducement Stock Incentive Plan.

Ocuphire Pharma Announces Presentation on APX3330 at the ARVO 2024 Annual Meeting

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måndag, maj 6, 2024
FDA, DRSS, PDR, Safety, Risk, Food, Diabetic retinopathy, Research, OCUP, Binocular, Retina, Patient, Eye, Annual general meeting, ARVO, DR, Pharmaceutical industry

ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.

Key Points: 
  • ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.
  • This 17-step person-level scale accounts for the DRSS scores of the two eyes and then anchors the step to the worse eye.
  • Fewer participants in the APX3330 group developed proliferative diabetic retinopathy (PDR) by week 24 compared to the placebo group (11% vs 26% respectively; p=0.13).
  • APX3330 showed favorable safety and tolerability, with similar ocular adverse events between APX3330 and placebo groups.

Ocular Therapeutix™ to Present at Two Upcoming Investor Conferences

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måndag, maj 6, 2024
Bank of America, Diabetic retinopathy, BofA Securities, Citizenship, Quality of life, Eye, Conference

BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it will participate at two investor conferences in May:

Key Points: 
  • BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it will participate at two investor conferences in May:
    A live webcast of the fireside chats at the Citizens JMP Life Sciences Conference and BofA Securities 2024 Health Care Conference can be accessed by visiting the Investors section of the Company’s website at investors.ocutx.com.

BioCryst Reports First Quarter 2024 Financial Results and Provides Business Update

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måndag, maj 6, 2024
Net, Skin, Investment, Solubility, Research, Diabetes, BioCryst Pharmaceuticals, Plasma, Injection, Webcast, Kallikrein, Prescription, Disease, Dehydration, Patient, Eye, Operating cost, Physician, Paratriathlon, EPS, Workforce, Infection, DME, Clinical trial, HAE, Diabetic retinopathy, Edema, Genetic disorder, GAAP, Netherton syndrome, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • These two successes helped us exceed our revenue projections for the quarter and, as a result, we are increasing our revenue guidance for 2024,” said Charlie Gayer, chief commercial officer of BioCryst.
  • Interest expense was $24.5 million in the first quarter of 2024, compared to $27.4 million in the first quarter of 2023 (-10.6 percent y-o-y).
  • Our references to our first quarter 2024 “non-GAAP pro forma” financial measures of adjusted net loss and adjusted earnings per share constitute non-GAAP financial measures.
  • ET today to discuss the financial results and provide a corporate update.

EyePoint Pharmaceuticals Announces Topline Data from the Phase 2 PAVIA Trial of DURAVYU™ in Non-Proliferative Diabetic Retinopathy

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måndag, maj 6, 2024
AMD, FDA, Safety, Retinal vasculitis, Conference call, Conference, Arm, Disease, TKI, Therapy, Patient, DME, Diabetic retinopathy, Endophthalmitis, Retina, Anti-VEGF, Pharmaceutical industry

WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced topline results of its Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). The data demonstrated that DURAVYU has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint. The Company plans to provide an update on the path forward for DURAVYU as a potential treatment in NPDR following a review of the full 12-month data.

Key Points: 
  • “The objective of the PAVIA trial was, for the first time, to evaluate DURAVYU as a potential treatment in a non-proliferative diabetic patient population,” said Jay Duker, M.D., Chief Executive Officer of EyePoint Pharmaceuticals.
  • I would like to thank the patients, the investigators and their site staff who participated in the PAVIA trial.
  • PAVIA is a 12-month, randomized, controlled Phase 2 clinical trial of DURAVYU in patients with moderately-severe to severe NPDR.
  • A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com .

Boehringer Ingelheim shares positive results from the first study worldwide in diabetic macular ischemia

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måndag, maj 6, 2024
Boehringer Ingelheim, Safety, Risk, Tissue, Diabetic retinopathy, Abstract, Research, Ingelheim am Rhein, Stanford School, Light, Principal, Master of Science, Paratriathlon, Geographic atrophy, Pediatrics, DMI, Quality of life, ARVO, DR, Medical device

Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI).

Key Points: 
  • Boehringer Ingelheim today presented positive data from the HORNBILL Phase I/IIa study of BI 764524, the first ever study exploring a potential treatment for people living with diabetic macular ischemia (DMI).
  • The current standard of care for advanced DR includes intravitreal anti-VEGF treatment or invasive laser treatment.
  • “Retinal non-perfusion is a key driver of vision loss in people living with diabetic retinopathy.
  • However, until the HORNBILL study, retinal non-perfusion has not been explored as a potential treatment target.”
    “Vision loss associated with retinal conditions such as diabetic retinopathy and DMI has a devastating impact on quality of life.