Intravitreal injection

Aldeyra Therapeutics Initiates Phase 2 Clinical Trial of ADX-2191 for the Treatment of Retinitis Pigmentosa

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Tuesday, March 8, 2022
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Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced that it has initiated a Phase 2 clinical trial of ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, for the treatment of retinitis pigmentosa (RP).

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced that it has initiated a Phase 2 clinical trial of ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, for the treatment of retinitis pigmentosa (RP).
  • RP is a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision.
  • ADX-2191 represents a novel approach for the treatment of patients with retinitis pigmentosa, an incurable, sight-threatening condition, stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
  • The single-center, open-label Phase 2 clinical trial will evaluate the safety and tolerability of ADX-2191 in patients diagnosed with RP due to mutations of the rhodopsin gene, including the P23H gene mutation.

Opthea Data for OPT-302 in Patients with Polypoidal Choroidal Vasculopathy (PCV) Presented at Angiogenesis 2022

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Monday, February 14, 2022
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MELBOURNE, Australia, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced data was presented at the Bascom Palmer 19th annual Angiogenesis, Exudation, and Degeneration 2022 Conference. The presentation, entitled “OPT-302 Combination Therapy with Ranibizumab for Treatment of Polypoidal Choroidal Vasculopathy,” was held virtually on Saturday, February 12, 2022, and appeared in a session highlighting “Emerging and Current Therapies for Exudative AMD.” Professor Gemmy Cheung MBBS, FRCOphth, FAMS, MCI, Head and Senior Consultant, Medical Retina Department, Singapore National Eye Center, Singapore Eye Research Institute, Singapore, presented.

Key Points: 
  • The presentation, entitled OPT-302 Combination Therapy with Ranibizumab for Treatment of Polypoidal Choroidal Vasculopathy, was held virtually on Saturday, February 12, 2022, and appeared in a session highlighting Emerging and Current Therapies for Exudative AMD.
  • Polypoidal Choroidal Vasculopathy (PCV) is a subtype of AMD that is particularly prevalent among Asian populations and demonstrates variable response to anti-VEGF-A therapy.
  • Sixty-six participants (18%) with PCV out of a total study population of 366 were included in the analysis.
  • We look forward to continuing to partner with Opthea to investigate the safety and efficacy of OPT-302 combination therapy targeting PCV.

ProQR Announces Top-Line Results from Phase 2/3 Illuminate Trial of Sepofarsen in CEP290-mediated LCA10

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Friday, February 11, 2022
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Given the results observed in earlier studies of sepofarsen, the Illuminate trial results are unexpected and disappointing, especially for people living with LCA10, said Daniel A. de Boer, Founder and CEO of ProQR Therapeutics.

Key Points: 
  • Given the results observed in earlier studies of sepofarsen, the Illuminate trial results are unexpected and disappointing, especially for people living with LCA10, said Daniel A. de Boer, Founder and CEO of ProQR Therapeutics.
  • We are deeply grateful to all of the participants, their supporters, and investigators who participated in the Illuminate study.
  • We will continue to work with ProQR to understand the data as they work to advance therapies for inherited retinal diseases.
  • Consistent with the findings observed in the Phase 1/2 trial, cataracts, CME, and retinal thinning were observed.

EyePoint Pharmaceuticals Announces Updated Positive Interim Safety and Efficacy Data from Ongoing Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD

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Saturday, February 12, 2022
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Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9013151-eyepoint-pharmaceuticals...

Key Points: 
  • Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9013151-eyepoint-pharmaceuticals...
    "Today's DAVIO clinical trial update further reinforces the potential for EYP-1901 as a durable anti-VEGF treatment in wet AMD," said Dr. Duker.
  • The interim eight-month follow-up data presented from the Phase 1 DAVIO clinical trial continue to show no reports of ocular serious adverse events (SAEs) or drug-related systemic SAEs.
  • The Phase 1 DAVIO trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD.
  • Positive interim eight-month safety data from the ongoing Phase 1 DAVIO clinical trial of EYP-1901 show no reports of ocular or drug-related systemic SAEs and no dose limiting toxicities.

Gemini Therapeutics Provides GEM103 Program Update

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Monday, January 10, 2022
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Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically-defined age-related macular degeneration (AMD), today announced updates from its ongoing phase 2a clinical studies of GEM103 and strategic evaluation of GEM103s clinical development program.

Key Points: 
  • Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically-defined age-related macular degeneration (AMD), today announced updates from its ongoing phase 2a clinical studies of GEM103 and strategic evaluation of GEM103s clinical development program.
  • Interim analysis showed that intravitreal GEM103 plus aflibercept was generally well-tolerated, and the safety profile was generally consistent with the sham plus aflibercept arm.
  • Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (AMD).
  • Gemini is also working to advance a potentiating antibody for CFH, GEM307, towards clinical development for treatment of systemic diseases.

Oxurion Provides Update on Clinical Pipeline Progress

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Friday, January 7, 2022
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The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.

Key Points: 
  • The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.
  • We are pleased to announce the completion of patient enrollment for Part A of the Phase 2 INTEGRAL trial of THR-687, Tom Graney, CFA, Chief Executive Officer of Oxurion commented.
  • This milestone brings us closer to delivering a potential first line treatment of choice for patients with DME.
  • Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US will present the Part A data on February 12th.

Adverum Biotechnologies Appoints Star Seyedkazemi, Pharm.D. as Chief Development Officer

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Thursday, January 6, 2022
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REDWOOD CITY, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Star Seyedkazemi, Pharm.D., joined Adverum as the companys chief development officer.

Key Points: 
  • REDWOOD CITY, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Star Seyedkazemi, Pharm.D., joined Adverum as the companys chief development officer.
  • Dr. Seyedkazemi will serve as a member of Adverums executive committee and will report to Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies.
  • I am pleased to welcome Star to Adverum as we advance ADVM-022, our lead clinical program utilizing our proprietary vector capsid AAV.7m8, for the treatment of wet age-related macular degeneration, stated Dr. Laurent Fischer, president and chief executive officer at Adverum Biotechnologies.
  • I am thrilled to join the Adverum as we work to bring ADVM-022 to the five million patients suffering from wet AMD worldwide, stated Star Seyedkazemi, Pharm.D., chief development officer of Adverum Biotechnologies.

Aldeyra Therapeutics Completes Enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy

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Tuesday, January 4, 2022
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Part 1 of the GUARD Trial, which enrolled 110 patients, is being conducted in the United States.

Key Points: 
  • Part 1 of the GUARD Trial, which enrolled 110 patients, is being conducted in the United States.
  • ADX-629, an orally administered RASP modulator, is in Phase 2 proof-of-concept clinical trials in psoriasis, atopic asthma, and COVID-19.
  • Our clinical pipeline also includes ADX-2191 (intravitreal methotrexate 0.8%), in Phase 3 clinical testing for the prevention of proliferative vitreoretinopathy.
  • Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue.

UNITY Biotechnology Provides Program Updates and Anticipated Milestones for 2022

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Tuesday, January 4, 2022
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SOUTH SAN FRANCISCO, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced the design for its Phase 2 study of UBX1325 in wet age-related macular degeneration (AMD) and anticipated milestones for 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced the design for its Phase 2 study of UBX1325 in wet age-related macular degeneration (AMD) and anticipated milestones for 2022.
  • UNITY anticipates that a Tie2 x VEGF bispecific clinical candidate will be selected and enter IND-enabling studies in 2022.
  • UNITY is exploring a number of indications for UBX2050 and expects to nominate a Development Candidate in 2022.
  • The licensing agreement included an upfront payment and provides for development and approval milestones, as well as sales-based royalties per indication.

ProQR Announces Last Patient Has Completed 12 Month Visit in Phase 2/3 Illuminate Trial of Sepofarsen

Retrieved on: 
Tuesday, January 4, 2022
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The last patient having completed their 12 Month visit is an important milestone toward the top-line results from the Phase 2/3 Illuminate trial of our lead program sepofarsen for LCA10, said Daniel A. de Boer, Founder and Chief Executive Officer of ProQR.

Key Points: 
  • The last patient having completed their 12 Month visit is an important milestone toward the top-line results from the Phase 2/3 Illuminate trial of our lead program sepofarsen for LCA10, said Daniel A. de Boer, Founder and Chief Executive Officer of ProQR.
  • The primary endpoint for Illuminate is mean change from baseline in best-corrected visual acuity (BCVA) at Month 12.
  • The Illuminate trial was initiated based on data from a Phase 1/2 study, which indicated that at Month 12, patients treated with sepofarsen had an improvement in visual acuity, as measured by BCVA.
  • In the Phase 1/2 study, concordant improvements in measures of full-field stimulus testing (FST) and mobility were also observed, which are secondary endpoints in the Illuminate trial.