Macular edema

Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 Million

Retrieved on: 
Tuesday, April 2, 2024
Disease, Macular edema, NIU, Paratriathlon, Arm, Rule, Safety, Risk, Webcast, Inflammation, Patient, NEPTUNE, EDT, Master of Science, Haze, Prednisone, Visual acuity, Therapy, Sumitomo Pharma, Calendar, Share repurchase, JAK, Visual impairment, Physician, Hand, Pediatrics, Pharmaceutical industry

We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.

Key Points: 
  • We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.
  • The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily.
  • All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive.
  • The presentation and webcast details are also available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events.

US Retinal Specialists Highlight the Greatest Opportunity for Gene Therapies

Retrieved on: 
Tuesday, March 19, 2024
Retina, Stargardt disease, Macular edema, Retinitis pigmentosa, Eye, Intelligence, Paratriathlon, Hope, Stargardt, Adverum Biotechnologies, Safety, NAMD, Geographic atrophy, Ophthalmology, Diabetic retinopathy, Medical device

Unlike other organs, the eye's compact size and accessibility have made it an ideal application for gene therapies, offering targeted treatment with minimal systemic impact.

Key Points: 
  • Unlike other organs, the eye's compact size and accessibility have made it an ideal application for gene therapies, offering targeted treatment with minimal systemic impact.
  • As advancements continue, a plethora of gene therapies for retinal disorders are on the horizon.
  • Spherix Global Insights collaborated with 77 retinal specialists to understand their perspectives on adopting gene therapies, specifically where specialists were and were not willing to use gene therapy across diseases and patient types.
  • While retinal specialists express eagerness for gene therapies, dissatisfaction towards current treatments like Syfovre and Izervay underscores the need for innovation.

Alimera Announces First Patient Randomized in Radiation Retinopathy Trial Being Conducted by the DRCR Retina Network

Retrieved on: 
Tuesday, March 19, 2024
Macular edema, Fluocinolone acetonide, Observation, Intravitreal implants, Injection, Risk, Paratriathlon, Patient, Alimera Sciences, Plaque, Cleveland Clinic, Retina, Brachytherapy, Radiation, Physician

ATLANTA, March 19, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the first patient has been randomized in the DRCR Retina Network’s Protocol AL. The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.”

Key Points: 
  • ATLANTA, March 19, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the first patient has been randomized in the DRCR Retina Network’s Protocol AL.
  • The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.”
    The study, chaired by Arun Singh, M.D.
  • (Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy.
  • “We are very excited that this study is underway as it has the potential to show ILUVIEN addressing another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera.

Alimera Sciences Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Thursday, March 7, 2024
CFO, EDT, Acquisition, Total, Injection, Trosia, Investment, Physician, Inflammation, Growth, Eye, Adjustment, Conference, Safety, Alimera Sciences, Depreciation, Patient, Tax, SLR, DME, Macular edema, Video game

ATLANTA, March 07, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announced financial results for the fourth quarter and full year 2023. Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.

Key Points: 
  • Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.
  • “We are proud to have achieved positive Adjusted EBITDA during the fourth quarter of 2023, while maintaining a consistent net loss compared to the fourth quarter of 2022, despite facing greater interest and amortization expenses following the YUTIQ acquisition.
  • For 2023, international net revenue increased 21% to approximately $24.0 million for 2023, compared to approximately $19.9 million in 2022.
  • All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Paratriathlon, Inflammation, Ranibizumab, Research, Ophthalmology, RVO, Patient, Diabetic retinopathy, Swelling, CRVO, BRVO, Food, ROG, Bascom Palmer Eye Institute, Retina, Blood, Macular edema, Angiogenesis, Roche, Eye, CST, Telescopic sight

In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

Key Points: 
  • In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.
  • Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
  • In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
  • “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis.

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept)

Retrieved on: 
Wednesday, January 3, 2024
Paratriathlon, Diabetic retinopathy, Macular degeneration, AMD, Macular edema, Patient, Safety, Generic drug

REYKJAVIK, Iceland, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept).

Key Points: 
  • “The progress of our product pipeline clearly illustrates the advantage of our integrated development and manufacturing platform, which allows Alvotech to pursue its diversified global biosimilar strategy,” said Robert Wessman, Chairman and CEO of Alvotech.
  • In the last twelve months before September 30, 2023, cumulative global sales of Eylea were about US$9.4 billion [1].
  • The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in patients with neovascular (wet) AMD.
  • The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Floater, Cataract, Marketing, Protein, BRVO, INN, Neovascularization, Complication, ATC, DME, Endophthalmitis, Retinal detachment, Blood, Bleeding, International, Ranibizumab, AMD, Injection, Disease, Diabetes, Language, CRVO, Eye, Pressure, Swelling, Inflammation, Intraocular pressure, RVO, European Medicines Agency, Infection, Cerebral edema, CNV, Growth, Select, Macular edema, Patient, Safety, Anatomy, Paratriathlon, Retina, IIA, Retinal haemorrhage, Three-body problem, Medical device

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 1, Status: Authorised

Oculis Announces First Patient First Visit in Phase 3 DIAMOND-1 Trial of OCS-01 Eye Drop in Diabetic Macular Edema

Retrieved on: 
Monday, December 18, 2023
Stage 2, DME, Pain, Macular edema, Inflammation, University, CST, Week, OCS, Telecanthus, University of Nevada, Reno, Patient, Safety, Diabetic retinopathy, Paratriathlon, Pharmaceutical industry

DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients.

Key Points: 
  • DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients.
  • The primary objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148).
  • Furthermore, 27.4% of patients in the OCS-01 group achieved ≥15-letter improvement in BCVA from baseline vs. 7.5% in the vehicle group at Week 12 (p=0.009).
  • OCS-01 eye drops have emerged as a potential solution for this unmet need, and the encouraging results from Stage 1 of the DIAMOND-1 Phase 3 trial support this outlook.

Rezolute to Participate in BTIG’s 3rd Annual Ophthalmology Day

Retrieved on: 
Friday, November 17, 2023
Rezolution Pictures, Macular edema, Ophthalmology, Pharmaceutical industry

REDWOOD CITY, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the management team will participate in BTIG’s 3rd Annual Ophthalmology Day, taking place virtually on November 27th.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the management team will participate in BTIG’s 3rd Annual Ophthalmology Day, taking place virtually on November 27th.
  • The Rezolute team is scheduled to participate in a question and answer session on November 27th at 11:30 am PT / 2:30 pm ET, including a discussion of RZ402, its oral plasma kallikrein inhibitor for diabetic macular edema.
  • The Company will also hold investor meetings over the course of the conference day.

Rezolute Reports First Quarter Fiscal 2024 Results

Retrieved on: 
Monday, November 13, 2023
Sunrize Band, Safety, European Medicines Agency, Investment, Chi, Patient, Rezolution Pictures, Macular edema, Research, DME, FDA, Pharmacokinetics, Hyperinsulinism, Trial of the century, Neoplasm, Congenital hyperinsulinism, Pharmaceutical industry

REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023.

Key Points: 
  • REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023.
  • “We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication,” said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute.
  • “We also anticipate completing enrollment this quarter for our ongoing Phase 2 study of RZ402 for the treatment of diabetic macular edema and plan to provide an update on the study prior to year end.”
    Plan to initiate sunRIZE, a pivotal Phase 3 clinical study in patients with cHI, in Europe and other geographies outside the US in the fourth quarter 2023
    Continuing the administration of RZ358 in the US with FDA approval under a compassionate use program to treat patients with tumor associated hyperinsulinism, including for a patient with refractory hypoglycemia due to metastatic insulinoma who has remained on RZ358 for nearly a year
    Multi-center, randomized, double-masked, placebo-controlled, parallel-arm study ongoing to evaluate the safety, efficacy, and pharmacokinetics of RZ402 administered as a monotherapy over a 12-week treatment period in participants with DME who are naïve to or have received limited anti-VEGF injections
    Cash, cash equivalents and investments in marketable debt securities totaled $106.9 million as of September 30, 2023, compared to $118.4 million as of June 30, 2023
    Research and development expenses were $12.2 million for the first quarter of fiscal 2024, compared to $7.7 million for the same period in fiscal 2023, with the increase primarily attributable to increased expenditures in clinical trial activities, manufacturing costs and higher personnel-related expenses which included employee compensation and stock-based compensation
    General and administrative expenses were $3.7 million for the first quarter of fiscal 2024, compared to $2.5 million for the same period in fiscal 2023, with the increase primarily attributable to higher personnel-related expenses, including employee compensation and stock-based compensation
    Net loss was $14.5 million for the first quarter of fiscal 2024, compared to $9.8 million for the same period in fiscal 2023