Allergic conjunctivitis

Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis

Retrieved on: 
Thursday, June 15, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Clinical trial, Telecanthus, Therapy, Patient, Allergic conjunctivitis, Pharmaceutical industry, Medical imaging

The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.

Key Points: 
  • The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.
  • The key secondary endpoint was change from baseline in ocular redness on a 0‑4 point scale over the duration of the allergen chamber (approximately 3.5 hours).
  • A live webcast of the conference call will be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com .
  • After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Top-Line Results from the Phase 3 INVIGORATE‑2 Trial in Allergic Conjunctivitis

Retrieved on: 
Wednesday, June 14, 2023
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Optical, Science, Oncology, Webcast, Therapy, Allergic conjunctivitis, Pharmaceutical industry, Broadcasting

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, June 15, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 3 INVIGORATE‑2 Trial of reproxalap in allergic conjunctivitis.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, June 15, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 3 INVIGORATE‑2 Trial of reproxalap in allergic conjunctivitis.
  • The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers.
  • A live audio webcast of the conference call also will be accessible from the “Investors & Media” section of Aldeyra's website at ir.aldeyra.com .
  • After the live webcast, the event will remain archived on Aldeyra’s website for 90 days.

Allergic Conjunctivitis (AC) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape Report 2023 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 24, 2023
Biotechnology, Pharmaceutical, Health, Allergic conjunctivitis, Acquisition, Therapy, Competitive landscape, AC, Medical device, Pharmaceutical industry

The "Allergic Conjunctivitis (AC) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Allergic Conjunctivitis (AC) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape" report has been added to ResearchAndMarkets.com's offering.
  • This reports provides a data-driven overview of the current and future competitive landscape in AC therapeutics.
  • The innovator marketed drugs space for AC mainly consists of dual-acting antihistamines and mast cell inhibitors.
  • Clinical trial space in AC mainly includes commercial sponsors, with the US emerging as the key country for conducting Phase III trials.

Ocular Therapeutix™ Provides First Quarter 2023 Financial Results and Corporate Update

Retrieved on: 
Monday, May 8, 2023
Glaucoma, ASC, ARVO, Clinic, Clinical trial, Marketing, AMD, Trial of the century, Eye, Research, Inflammation, Pain, Intraocular pressure, Interest, Ocular hypertension, Patient, Ophthalmology, Allergic conjunctivitis, Growth, Webcast, Depreciation, Diabetic retinopathy, Axitinib, FDA, Summit, Safety, Video game, Pharmaceutical industry, Cryptocurrency, Abdominal ultrasonography

BEDFORD, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today reported financial results for the first quarter ended March 31, 2023, and provided updates on its ophthalmology pipeline.

Key Points: 
  • “The strong start to the year has continued through the end of the first quarter,” said Antony Mattessich, President and CEO.
  • This trial continues to enroll well, and we continue to anticipate providing top-line data from this trial in the fourth quarter of 2023.
  • In-market billable unit volumes were approximately 8% ahead of fourth quarter volumes, and we continue to guide towards a full year 2023 net product revenue of $55 to $60 million.
  • Non-cash charges for stock-based compensation and depreciation and amortization were $5.1 million in the first quarter of 2023 versus $4.8 million for the comparable quarter in 2022.

Aldeyra Therapeutics Reports First-Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, May 4, 2023
Biotechnology, Pharmaceutical, Optical, Health, RASP, Psoriasis Area and Severity Index, Adaptation, Retinitis pigmentosa, Quality of life, Atopic dermatitis, Methotrexate, Pollen, Part, Inflammation, Chronic cough, Clinical trial, Patient, Standard of care, Enrollment, Malondialdehyde, Allergy, PDUFA, Electroretinography, Allergic conjunctivitis, Therapy, Visual acuity, Safety, Pharmaceutical industry, Medical imaging

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended March 31, 2023.
  • Top-line results from the Phase 2 clinical trial are expected in the second quarter of 2023.
  • Beginning with this announcement of first quarter 2023 financial results, Aldeyra will no longer conduct quarterly conference calls to discuss financial results.
  • Aldeyra plans to continue hosting conference calls, as appropriate, to report the results of certain clinical trials and other material information concerning regulatory and clinical developments.

Nicox’s Partner Ocumension Therapeutics Receives Priority Review Status for ZERVIATE New Drug Application in China

Retrieved on: 
Friday, April 28, 2023
New Drug Application, NDA, Euronext Paris, Patient, Allergic conjunctivitis, National Medical Products Administration, Therapy, COX, NMPA, Pharmaceutical industry

This will accelerate the approval process and potentially the launch of ZERVIATE in China.

Key Points: 
  • This will accelerate the approval process and potentially the launch of ZERVIATE in China.
  • The ZERVIATE NDA in China is supported by the data package licensed by Nicox to Ocumension and an additional Chinese Phase 3 clinical trial of ZERVIATE run by Ocumension.
  • The inclusion of ZERVIATE in the priority review and approval process of NMPA will accelerate the review and approval process of its new drug application, which is an important step towards commercialization of ZERVIATE.
  • ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets.

Nicox Provides First Quarter 2023 Financial and Business Highlights

Retrieved on: 
Wednesday, April 19, 2023
Mont Blanc, NCX, IOP, ARVO, COVID-19, Nitric oxide, American Glaucoma Society, WGC, Intraocular pressure, Bausch & Lomb, Glaucoma, Congress, Ocular hypertension, Euronext Paris, Publication, Patient, Allergic conjunctivitis, Lifting, Communication, Marshal of France, Association for Research in Vision and Ophthalmology, Research, Annual report, COX, AGS, Pharmaceutical industry, Ophthalmology

Cash position of €21.4 million as of March 31, 2023

Key Points: 
  • Cash position of €21.4 million as of March 31, 2023
    Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided financial and business highlights for the first quarter 2023 for Nicox SA and its subsidiaries (the “Nicox Group”).
  • As of March 31, 2023, the Nicox Group had cash and cash equivalents of €21.4 million as compared with €27.7 million as of December 31, 2022.
  • The payment of this debt would only occur if the put option was exercised, subject to the conditions set out in footnote 2 below.
  • VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% U.S. prescriptions3 increased by 23% in the first quarter of 2023 compared to the same period in 2022.

Additional Future Royalty Revenue Stream for Nicox from 2024 following New Drug Application Submission for ZERVIATE in China

Retrieved on: 
Friday, April 14, 2023
NCX, New Drug Application, NDA, Euronext Paris, Patient, Ophthalmology, Allergic conjunctivitis, Therapy, COX, Pharmaceutical industry

The approval process is expected to take around 12 months, leading to a potential launch of ZERVIATE in China in 2024.

Key Points: 
  • The approval process is expected to take around 12 months, leading to a potential launch of ZERVIATE in China in 2024.
  • Ocumension plans to manufacture ZERVIATE in their new state-of-the-art purpose-built manufacturing facility located in Suzhou, China.
  • “Ocumension is a strong partner for Nicox, and we are pleased to see the submission of this New Drug Application, following the completion of an additional Chinese Phase 3 trial carried out by Ocumension.
  • “The approval and launch of ZERVIATE in 2024 would add another royalty revenue stream to Nicox, on potential annual net sales which Ocumension forecasts will be over $100 million within 7 years in China.

AXIM® Biotechnologies Commences Commercial Manufacturing of FDA-Cleared Proprietary Ocular Diagnostic Assays

Retrieved on: 
Tuesday, April 11, 2023
DED, Therapy, Telecanthus, American Academy, American Academy of Ophthalmology, American Journal, Patient, SAN, Allergic conjunctivitis, Vision science, Quality control, Diagnosis, Immunoglobulin E, Pharmaceutical industry, Medical imaging, Lactoferrin, Biotechnology, Ophthalmology

SAN DIEGO, CA, April 11, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today the start of manufacturing of both its proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner. As is a standard manufacturing practice, AXIM has begun manufacturing three separate lots of each assay that will be used for an internal reproducibility study with the third lot available to ship to customers. AXIM’s current manufacturing capacity is up to 25,000 units per month.

Key Points: 
  • ( OTCQB: AXIM ) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today the start of manufacturing of both its proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner.
  • Unlike other clinically available assays, AXIM’s tests are quantitative and measures actual levels of both IgE and Lactoferrin allowing doctors to monitor targeted therapeutics.
  • Low Lactoferrin levels indicate DED and depressed ocular immunity, which may represent an increased surgical risk and of contact lens intolerance.
  • AXIM aims to address this discrepancy with its ocular diagnostic solution portfolio, beginning with both its IgE and Lactoferrin assays.

Aldeyra Therapeutics Completes Enrollment in Phase 3 INVIGORATE-2 Clinical Trial in Allergic Conjunctivitis

Retrieved on: 
Thursday, April 13, 2023
Pharmaceutical, Health, Clinical Trials, Pollen, Therapy, Patient, Allergic conjunctivitis, Pharmaceutical industry

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis.
  • “Today, millions of allergic conjunctivitis patients rely on therapies that may not provide sufficient relief or cannot be used chronically due to serious side effects,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
  • Consistent with pivotal trials of approved allergic conjunctivitis products, the primary endpoint of INVIGORATE-2 is patient-reported ocular itching.
  • Top-line results from the trial are expected in the first half of 2023.