PhRMA

FEBRUARY 1, 2023

Excitingly, as of January 2023, there are 18 medicines in development to treat glaucoma that are either in clinical trials or under review by the FDA — part of the over 80 medicines in development for common eye conditions, including age-related macular degeneration, cataracts, diabetic macular edema and diabetic retinopathy.

FDA 188

FDA 188

European Pharmaceutical Review

NOVEMBER 6, 2023

IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced.

FDA 82

FDA 82

PharmaShots

FEBRUARY 28, 2023

In preclinical studies, IBI333 has proven effective at preventing angiogenesis and vascular leakage and has exhibited a dose-dependent efficacy IBI333 is a recombinant anti-VEGF-A and anti-VEGF-C bispecific fusion protein that has been developed by Innovent.

40

40

European Pharmaceutical Review

AUGUST 18, 2023

Clinical evidence that supported the marketing authorisation application The MAA is based on the GATHER1 and GATHER2 Phase III clinical trials. By targeting this protein, ACP has potential to reduce activity of the complement system that causes the degeneration of retinal cells.

FDA 85

FDA 85

Pharmafile

APRIL 21, 2023

GA is a progressive form of age-related macular degeneration and a leading cause of sight loss. RetinAI will combine its novel biomarkers analysis Discovery platform and AI tools, with Boehringer Ingelheim’s imaging datasets from clinical studies and real-world evidence in retinal diseases. read more

Communication 52

Communication 52

pharmaphorum

JANUARY 25, 2021

Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from Novartis and Bayer strengthens. Detailed findings will be presented next month at the Angiogenesis, Exudation and Degeneration 2021 conference in Miami.

FDA 96

FDA 96

pharmaphorum

NOVEMBER 16, 2022

Novartis completed the spin-out of Alcon in 2019, separating products like contact lenses and over-the-counter eyedrops from its prescription eye medicines, headed by age-related macular degeneration (AMD) blockbuster Lucentis (ranibizumab), which is partnered with Roche. billion in the first nine months of this year.

124

124

PharmaShots

MAY 30, 2023

analytical, in vitro non-clinical data, and clinical data. The P-III study showed an equivalent clinical efficacy of Epysqli (first approved hematology biosimilar) over eculizumab after evaluating LDH in PNH patients Additionally, the company has seven biosimilars approved for use in the EU incl.

40

40

PharmaShots

MAY 10, 2023

Shots: Under the terms of the agreement, Alvotech will lead the development and manufacture while Polifarma will be responsible for the market registration and commercialization The partnership aims to increase patient access to affordable biologics & also allows Polifarma to diversify its portfolio and strengthen its position in the ophthalmology (..)

40

40

PharmaShots

APRIL 14, 2023

Shots: The US FDA has cleared the IND to initiate the P-II clinical trials (SIGLEC) of AVD-104, an intravitreal nanoparticle molecule with a unique dual MoA for treating GA secondary to AMD. The company is working on many different therapeutic areas, inc.

FDA 40

FDA 40

pharmaphorum

DECEMBER 8, 2020

The first project under a new master agreement will involve a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD). The study will be conducted in several clinical centres in several European countries and Canada, involving more than 500 patients.

121

121

Pharmaceutical Technology

MAY 31, 2023

BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through oral and rectal route.

52

52

Pharmaceutical Technology

MARCH 30, 2023

The topical and oral form of the compound is intended to treat glaucoma and dry age-related macular degeneration (AMD), as well as other ophthalmic indications with high unmet medical need, in Africa, the Middle East, the Americas and Europe. It is currently ready to enter Phase II/III clinical trials.

Compounding 52

Compounding 52

Pharmaceutical Technology

JUNE 5, 2023

OCX-063 is under clinical development by OccuRx and currently in Phase I for Proliferative Vitreoretinopathy (PVR). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

52

52

Pharmaceutical Technology

MAY 19, 2023

EYP-1901 is an investigational sustained delivery intravitreal anti-VEGF treatment which is now being evaluated in Phase II clinical trials. It provides steady blocking of VEGFR to prevent loss of vision and neovascularisation.

52

52

Pharmaceutical Technology

JULY 22, 2022

Pipeline therapies within the diabetic macular oedema (DME) space have recently gathered interest following the American Society of Retina Specialists (ASRS) Annual Meeting, which took place on 13–16 July.

Hospitals 104

Hospitals 104

Pharmaceutical Technology

APRIL 24, 2023

Pegcetacoplan is an investigational targeted C3 therapy intended to treat geographic atrophy (GA) which is secondary to age-related macular degeneration (AMD). It targets excessive activation of the complement cascade, which is part of the body’s immune system.

Immunization 52

Immunization 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

The European Commission (EC) has granted approval for Roche's Vabysmo (faricimab) to treat two retinal conditions, neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) associated visual impairment. .

52

52

Pharmaceutical Technology

JUNE 13, 2023

Amongst it was AGTC’s lead clinical candidate, AFTC-501, an adeno-associated virus (AAV) gene therapy for XLRP. The asset, now transferred to Beacon Therapeutics, is currently in Phase II clinical trials. In late 2022, Syncona acquired AGTC for $23.5m and with it a portfolio of ophthalmic pipeline candidates.

98

98

European Pharmaceutical Review

FEBRUARY 21, 2023

GA is an advanced form of age-related macular degeneration (AMD). SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness.

FDA 92

FDA Adverse Reactions 92

pharmaphorum

FEBRUARY 3, 2021

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics.

Labelling 98

Labelling Hospitals 98

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also develops drugs on DARPin base technology and other product candidates.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Immunization 40

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also develops drugs on DARPin base technology and other product candidates.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Immunization 40

pharmaphorum

SEPTEMBER 20, 2021

The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two other eye conditions, and is the first ophthalmology biosimilar to be registered by the FDA. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1

FDA 71

FDA Labelling 71

Pharmaceutical Technology

JULY 28, 2022

Late-stage pipeline therapies for GA have shown promising results in clinical trials associated with this stage of development, and there is anticipation that these therapies will receive approval during the forecast period. A one-time treatment option would represent a significant shift in the treatment burden for wAMD.

FDA 52

FDA Labelling 52

pharmaphorum

JULY 25, 2022

Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricing and reimbursement negotiations.

FDA 98

FDA Immunization 98

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Thus, the biosimilar presented a similar efficacy to the reference product.

FDA 52

FDA Insurance 52

pharmaphorum

SEPTEMBER 14, 2022

SparingVision has raised €75 million in second-round funding that will be used to fund clinical trials of gene therapies for ocular diseases retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD).

FDA 52

FDA 52

pharmaphorum

NOVEMBER 16, 2022

Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. Working against the odds. “As The specifics of an exciting prospect.

FDA 105

FDA Immunization Hospitals 105

European Pharmaceutical Review

MAY 2, 2023

Under the agreement, Astellas will accelerate clinical development and commercialisation of treatments for conditions such as geographic atrophy (GA). Astellas Pharma has agreed to acquire ophthalmology biotech company Iveric Bio, Inc. for approximately $5.9

FDA 52

FDA 52

PharmaShots

FEBRUARY 24, 2023

Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive

FDA 40

FDA Vaccines 40

pharmaphorum

SEPTEMBER 9, 2022

A higher dose of Regeneron and Bayer’s Eylea given every three or four months has shown efficacy in a pair of clinical trials, in a big boost for the multibillion-dollar product.

Labelling 52

Labelling 52

pharmaphorum

AUGUST 23, 2022

If completed, the deal will add two commercial products to Alcon’s range – glaucoma therapies Rocklatan (netarsudil/latanoprost) and Rhopressa (netarsudil) – as well as a pipeline of clinical and preclinical drug candidates currently headed by AR-15512, in phase 3 for dry eye disease.

58

58

Pharmaceutical Technology

FEBRUARY 28, 2023

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Paroxysmal Nocturnal Hemoglobinuria. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Generic Medicine 40

Generic Medicine Immunization 40

Pharmaceutical Technology

FEBRUARY 28, 2023

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase III for Glomerulonephritis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Generic Medicine 40

Generic Medicine Immunization 40

Pharmaceutical Technology

JUNE 2, 2023

The AAV material will be used for the planned pre-clinical testing of the new gene therapy of Ikarovec to treat geographic atrophy, an advanced form of age-related macular degeneration that may result in the progressive and irreversible destruction of retinal tissue.

52

52

pharmaphorum

DECEMBER 22, 2021

The Swiss pharma group has agreed to pay $800 million upfront for London, UK-based Gyroscope, with another $700 million to be paid if GT005 meets its objectives in terms of clinical development, regulatory approvals and reimbursement.

Immunization 105

Immunization FDA 105