Uveitis

Bausch + Lomb Announces the Presentation of New Data on Products and Pipeline Programs at the Association for Research in Vision and Ophthalmology Meeting

Retrieved on: 
Thursday, April 20, 2023

“Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.

Key Points: 
  • “Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.
  • “Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey.” Chang et al.
  • “Longitudinal Analysis of In Vitro Antibiotic Resistance Among Ocular Staphylococci Collected in the ARMOR study.” Asbell et al.
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Alimera Announces Expansion of Agreement with Distribution Partner Horus Pharma to Include Marketing ILUVIEN® in the Nordic Countries

Retrieved on: 
Monday, April 3, 2023

Alimera and Horus have agreed to expand their relationship beyond France, Belgium, Luxembourg and the Netherlands to increase the commercialization efforts for ILUVIEN for both diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in the Nordic countries of Denmark, Finland, Norway and Sweden.

Key Points: 
  • Alimera and Horus have agreed to expand their relationship beyond France, Belgium, Luxembourg and the Netherlands to increase the commercialization efforts for ILUVIEN for both diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in the Nordic countries of Denmark, Finland, Norway and Sweden.
  • “We continue to see great results from Horus selling ILUVIEN and believe they will leverage their marketing and medical expertise to bring ILUVIEN to more patients in these markets,” said Rick Eiswirth, President and Chief Executive Officer of Alimera.
  • “ILUVIEN has become an asset for us, helping to drive our expansion throughout Europe.
  • As we launch into the Nordics, we see great potential in this market, which is eagerly awaiting long-acting therapies that can alleviate the burden on healthcare systems.”

Junshi Biosciences Announces 2022 Full Year Financial Results and Provides Corporate Updates

Retrieved on: 
Friday, March 31, 2023

SHANGHAI, China, March 31, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced financial results for the 2022 full year and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 31, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced financial results for the 2022 full year and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB 2,384 million in 2022, representing an increase of approximately 15% compared to 2021.
  • Loss attributable to the owners of the company was RMB 2,386 million in 2022, representing an increase of RMB 1,667 million compared to 2021.
  • In May 2022, the IND application for JS105, a PI3K-α inhibitor jointly developed by Risen (Suzhou) Biosciences Co., Ltd. (“Risen Biosciences”) and the company, was approved by the NMPA.

Alimera Sciences Announces 2022 Financial Results and Business Update

Retrieved on: 
Friday, March 31, 2023

ATLANTA, March 31, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) 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 2022.

Key Points: 
  • • 2022 Product Revenue Increased to $54.1 Million, Up 13% over 2021
    ATLANTA, March 31, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) 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 2022.
  • 2022 product revenue increased 13% to $54.1 million despite negative impact of foreign currency fluctuations in our international segment of $2.4 million.
  • Net revenue decreased by approximately $4.9 million, or 8%, to approximately $54.1 million for 2022, compared to approximately $59.0 million for 2021.
  • All callers should dial-in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.

Prominently featured in The Inner Circle, John T. Couvillion is acknowledged as Distinguished Healthcare Provider for his contributions to the retina and vitreous surgical field

Retrieved on: 
Tuesday, February 28, 2023

BATON ROUGE, La., Feb. 28, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, John T. Couvillion is acknowledged as Distinguished Healthcare Provider for his contributions to the retina and vitreous surgical field.

Key Points: 
  • BATON ROUGE, La., Feb. 28, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, John T. Couvillion is acknowledged as Distinguished Healthcare Provider for his contributions to the retina and vitreous surgical field.
  • Dr. Couvillion earned a Bachelor of Science degree in biology and Bachelor of Arts degree in history from the University of the Pacific.
  • He also completed a fellowship in vitreous and retinal surgery at Baylor University, College of Medicine.
  • Dr. Couvillion was granted a scholarship for additional training in Uveitis at McGill University in Montreal Canada.

Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)

Retrieved on: 
Tuesday, January 3, 2023

INCHEON, Korea, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that Health Canada has approved HADLIMA™ (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA® (adalimumab).

Key Points: 
  • INCHEON, Korea, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that Health Canada has approved HADLIMA™ (also known as SB5) - a citrate-free, high concentration (40 mg/0.4 ML) formulation of biosimilar referencing HUMIRA® (adalimumab).
  • “We are pleased to receive Health Canada approval of our high concentration adalimumab biosimilar, marking a key milestone for us now to have both a low and high concentration adalimumab biosimilar approved in Canada,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis.
  • The study demonstrated PK equivalence between new SB5 formulation and prior SB5 formulation in healthy subjects.
  • HADLIMA was previously approved by Health Canada as a low-concentration (40mg/0.8mL) formulation in May 2018.

Mabwell Bioscience Partners with Binnopharm Group to Market 9MW0113, 9MW0321 and 9MW0311 in Russia and Eurasian Economic Union Countries

Retrieved on: 
Tuesday, December 20, 2022

Mabwell's 9MW0321 and 9MW0311 have been filed for MA approval with the China National Medical Products Administration (NMPA) at the end of 2021.

Key Points: 
  • Mabwell's 9MW0321 and 9MW0311 have been filed for MA approval with the China National Medical Products Administration (NMPA) at the end of 2021.
  • This strategic partnership will leverage Binnopharm Group's strength as one of the biggest Russian pharmaceutical producers with significant manufacturing, registration, sales and marketing capabilities in Russia and Eurasian Economic Union countries.
  • This strategic partnership is the first to expand Mabwell's presence in Russia and Eurasian Economic Union countries, an important market for biosimilars and innovative drugs."
  • This cooperation also represents an important milestone for Binnopharm Group, and for our patients in Russia and Eurasian Economic Union countries that will ensure the social benefit from an increased access to high-quality affordable medicines."

Junshi Biosciences Announces Approval of Supplemental Application for Additional Indications of Adalimumab Injection

Retrieved on: 
Tuesday, November 22, 2022

is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd.

Key Points: 
  • is jointly developed by Junshi Biosciences and Mabwell (Shanghai) Bioscience Co., Ltd.
  • In March 2022, its indications including rheumatoid arthritis, ankylosing spondylitis and psoriasis were approved by the NMPA.
  • Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Oculis announces publication of positive Phase 2 data in Translational Vision Science & Technology (TVST) investigating topical anti-TNFα agent licaminlimab (OCS-02) in acute anterior uveitis

Retrieved on: 
Tuesday, November 22, 2022

The study, Topical Ocular Anti-TNF Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study, is accessible on the National Institutes of Health (NIH) website here .

Key Points: 
  • The study, Topical Ocular Anti-TNF Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study, is accessible on the National Institutes of Health (NIH) website here .
  • Licaminlimab (OCS-02) was observed to be well tolerated, including no increase in intra-ocular pressure related to licaminlimab (OCS-02).
  • Licaminlimab (OCS-02) is an anti-TNF antibody product candidate based on an innovative antibody fragment technology allowing it to be administered topically.
  • Phase 2b clinical trials of licaminlimab (OCS-02) for the treatment of non-infectious anterior uveitis, as well as dry eye disease (DED), are currently being planned by Oculis.

Aldeyra Therapeutics Reports Third-Quarter 2022 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, November 10, 2022

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended September 30, 2022.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended September 30, 2022.
  • In addition to efficacy data, Aldeyra plans to submit up to 12 months of reproxalap safety data.
  • Pending the results of the pre-NDA meeting, NDA submission may occur as soon as the end of 2022.
  • ET today to discuss recent corporate highlights and financial results for the quarter ended September 30, 2022.