Glaucoma - Competitive Landscape, 2023

Glaucoma - Competitive Landscape, 2023

DelveInsight’s, “Glaucoma - Competitive landscape, 2023,” report provides comprehensive insights about 45+ companies and 50+ drugs in Glaucoma Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

Global coverage

Glaucoma: Understanding

Glaucoma: Overview

According to the American Academy of Ophthalmology, glaucoma describes a group of conditions in which there is characteristic cupping of the optic disc with corresponding visual field defects due to retinal ganglion cell loss. It is a progressive condition and the most common cause of irreversible blindness worldwide. The two major categories of glaucoma are open-angle glaucoma and narrow-angle glaucoma/angle-closure glaucoma. The “angle” in both cases refers to the drainage angle inside the eye that controls the outflow of the watery fluid (aqueous) which is being produced inside the eye.

Open-angle glaucoma (OAG) is the most common form of the disease. The drainage angle formed by the cornea and iris remains open, but the trabecular meshwork is partially blocked. This causes pressure in the eye to increase gradually and damages the optic nerve. It happens so slowly that the patient may lose vision before they are even aware of a problem, while in the case of narrow-angle glaucoma, the structure inside the eye that allows fluid to drain normally from the eye (called the drainage angle) becomes restricted. Narrow drainage angles in the eye increase the risk of the drainage angle that gets blocked, resulting in a significant increase in eye pressure and risk of vision loss. If this occurs, narrow-angle glaucoma is usually called angle-closure glaucoma.

Most people with glaucoma do not notice symptoms until they begin to lose eyesight. As glaucoma damages optic nerve fibers, small blind spots may begin to develop. These spots usually occur on the side or in the peripheral vision. Many people do not notice the blind spots until significant optic nerve damage has already happened. Blindness can result when the entire nerve is destroyed.

Given the asymptomatic development of early-stage glaucoma, the disease often progresses significantly before it is detected. For many years, it was believed that glaucoma affected primarily peripheral vision and central vision was left unharmed until very late in the disease. Contrary to this dogma, research now shows that loss of peripheral vision is not an early indication of the disease, and that the full range of vision (peripheral and central) is often affected. Further, the visual field tests are not sensitive to early vision losses. By the time glaucoma is detected by a peripheral field test in many patients, more than half of the optic nerve fibers are damaged or have perished. Research is ongoing to perfect better tests for central vision that can detect the disease in earlier stages.

It is an inherited disease, meaning that if person have a family history of glaucoma, person are at increased risk. Additional risk factors include thin corneas or people with thinning of the optic nerve, general health conditions such as diabetes, obesity and circulatory problems, and other eye issues like extreme myopia and hyperopia.

There is no cure for glaucoma, but early treatment can often stop the damage and protect the vision. Doctors use a few different types of treatment for glaucoma, including medicines (usually eye drops), laser treatment, and surgery.

Report Highlights

In December 2022, Visiox Pharma announced that it had received notification from the US Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma.

In October 2022, Essex Biotechnology Ltd announced that its wholly-owned subsidiary Essex Bioinvestment Ltd had secured (i) a patent and know-how license agreement; and (ii) a patent assignment deed in relation to SkQ1, an active pharmaceutical ingredient, from Mitotech S.A. Under these Agreements, Mitotech grants Essex Bioinvestment worldwide rights (excluding Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia) and interests in SkQ1, transferable and irrevocable, in the field of ophthalmology exclusively.

On October 6, 2022, Santen Pharmaceutical announced that the European Medicines Agency (EMA) had accepted the Santen filing for reviewing the marketing authorization application for the use of STN1013001 for the lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. The marketing authorization application is based on a clinical package that includes positive results from a Phase III clinical trial conducted in Europe and Asia – a non-inferiority trial of STN1013001.

In September 2022, TearClear announced that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%), met the primary and all secondary endpoints in the CLEAR Phase III pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023.

In May 2022, Qlaris Bio, Inc., announced results from QC-201, a first-in-human, Phase 2 clinical trial of QLS-101, the Company’s investigational therapy for lowering intraocular pressure (IOP) in the treatment of glaucoma. Study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness), as well as a positive efficacy signal, in patients with primary open-angle glaucoma (POAG) or ocular hypertension.

In December 2021, Sun Pharma Advanced Research Company Ltd. announced that it had entered into an agreement with Visiox Pharma LLC (Visiox) to grant exclusive worldwide rights (except for India and Greater China) for the development and commercialization of PDP-716 and SDN-037. Under the terms of the license agreement, SPARC received an upfront payment, milestone payments, and royalties on sales, in addition to 10% equity* in Visiox.

Glaucoma: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Allergan

Allergan plc is an American, and Irish-domiciled pharmaceutical company that acquires, develops, manufactures, and markets brand-name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. Subsidiary of AbbVie, Inc. In May 2020, AbbVie announced the completion of its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. In June 2019, AbbVie and Allergan entered into a definitive transaction agreement under which AbbVie acquired Allergan in a cash and stock transaction for a transaction equity value of approximately USD 63 billion, based on the closing price of AbbVie’s common stock of USD 78.45 on June 24, 2019.

Product Description: DURYSTA

DURYSTA is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with OAG or OHT. Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. Bimatoprost is believed to lower IOP in humans by increasing the outflow of aqueous humor through both the trabecular meshwork (conventional) and uveoscleral routes (unconventional). Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. DURYSTA is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant containing 10 mcg bimatoprost. DURYSTA should not be re-administered to an eye that that has previously received DURYSTA. DURYSTA is preloaded into a single-use applicator to facilitate the administration of the biodegradable implant directly into the anterior chamber of the eye.

2. Company Overview: Sun Pharma Advanced Research Company Limited

Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage biopharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. SPARC aims to consistently lower costs and improve operational efficiencies to advance the availability and affordability of cures for patients across the world.

Product Description: XELPROS

XELPROS is a prostaglandin F2α analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. XELPROS is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. XELPROS is developed using Sun Pharma Advanced Research Company’s (SPARC’s) proprietary Swollen Micelle Micro emulsion (SMM) technology. As a prostaglandin analog that serves as a first-line treatment for its indicated conditions, XELPROS is recommended at doses of one drop in each infected eye once daily in the evening. The reduction of IOP is intended to begin 3–4 following administration, with maximum effect being observed 8–12 h following. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts approximately 3–4 h after administration and the maximum effect is reached after 8−12 h.

Glaucoma: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Nicox Ophthalmics

Nicox is an international ophthalmic company developing innovative therapeutics to help maintain vision and improve ocular health. The vision is to become a fully integrated ophthalmic pharmaceutical company with a direct presence in the US and in the major European markets.

Product Description: NCX 470

NCX 470 is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog that is currently being developed by Nicox Ophthalmics. NCX-470 may assist glaucoma patients by a mechanism other than IOP lowering, notably by enhancing ocular perfusion. IOP reduction is the most common treatment for glaucoma, and preliminary studies suggest that if approved, NCX-470's dual mechanistic approach (nitric oxide donation and prostaglandin F2 activity) could make it the most effective single-agent glaucoma medicine in terms of IOP-lowering efficacy. Currently, the drug is in Phase III stage of its clinical study for the treatment of open-angle glaucoma or ocular hypertension.

2. Company Overview: Tarsier Pharma

Tarsier Pharma is a phase-3 pharmaceutical company, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular back and front of the eye blinding diseases. TRS is a bio-inspired breakthrough proprietary technology platform, based on a new chemical entity with novel mechanism of action that demonstrated safety and efficacy in a rare debilitating and blinding indication.

Product Description: TRS01

Tarsier’s TRS01 is a potent, fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma, which is considered an end-stage condition of uveitis. Once a patient with uveitis has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided due to their side effects of expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma. TRS is being developed as an eye drop formulation, TRS01, to treat the signs and symptoms of active uveitis in patients with uveitic glaucoma. TRS01 is currently being investigated in a Phase III trial.

3. Company Overview: Qlaris Bio

Qlaris Bio discovers and develops novel therapeutics targeting ophthalmic diseases. The company’s lead program QLS-101, a novel topical ocular therapy, that lowers intraocular pressure with ATP sensitive potassium (KATP) channel modulator, by lowering episcleral venous pressure (EVP) and improves outflow distal to the trabecular meshwork. It is also investigating EVP-targeted therapies targeting sturge-weber syndrome and normal tension glaucoma. The company is a spinout of Qrativ a biotechnology incubator between Mayo Clinic and Nference. Qlaris Bio is headquartered in Wellesley, Massachusetts, the US.

Product Description: QLS-101

QLS-101, Qlaris Bio’s lead product candidate, is a prodrug of levcromakalim, an adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator. By lowering episcleral venous pressure (EVP) and increasing aqueous humor outflow through vessels distal to the trabecular meshwork, QLS-101 may be able to uniquely address diseases of pathologic EVP resulting in elevated intraocular pressure (IOP), such as Sturge-Weber syndrome-related glaucoma, and diseases where EVP limits maximal therapy, including primary open-angle glaucoma and normal-tension glaucoma. QLS-101 was invented at the Mayo Clinic and the University of Minnesota and is being developed under an exclusive worldwide license.

In the Phase II clinical trial, study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness) as well as a positive efficacy signal in patients with primary open-angle glaucoma (POAG) or ocular hypertension. Currently, the drug is in Phase II stage of its clinical study for the treatment of open-angle glaucoma or ocular hypertension.

4. Company Overview: Noveome Biotherapeutics

Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. The company is advancing ST266— a first-of-its-kind, multi-targeted secretome containing hundreds of biologically active proteins and other factors crucial to neuroprotection, the modulation of inflammation, cell recovery and healing.

Product Description: ST266

ST266 is a non-cellular biologic drug candidate, currently considered “investigational,” since it is not yet approved by the U.S. Food and Drug Administration (FDA). The clinical trials are designed to examine and confirm that ST266 is safe and effective in humans with the goal of bringing this unique product to potentially millions of patients who suffer from complex diseases and conditions in ophthalmology, neurology, dermatology—and beyond. ST266 is made by the proprietary method of culturing amnion epithelial cells that are harvested from donated full-term placentas normally discarded after birth. It contains hundreds of biologically active proteins and other factors crucial to neuroprotection, the modulation of inflammation, cell recovery and healing. These various proteins and factors are delivered in physiologic concentrations that have been shown, in preclinical and clinical studies to date, to be well-tolerated with demonstrated biologic activity. In preclinical studies, ST266 has been shown to be neuroprotective and to resuscitate damaged and diseased retinal ganglion cells, offering the possibility of a novel treatment for glaucoma. Currently, the drug is in Phase I stage of Clinical trial evaluation for the treatment of Glaucoma.

Further product details are provided in the report……..

Glaucoma Analytical Perspective by DelveInsight

In-depth Commercial Assessment: Glaucoma Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

Glaucoma Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Glaucoma Report Assessment

Company Analysis

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Glaucoma drugs?

How many Glaucoma drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Glaucoma?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Glaucoma therapeutics?

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

What are the clinical studies going on for Glaucoma and their status?

What are the key designations that have been granted to the emerging and approved drugs?

Key Players

Santen Pharmaceuticals

Visiox Pharma

Nicox Ophthalmics

pH Pharma

Omikron Italia

Tarsier Pharma

TearClear

Laboratoires Thea

EMS

Peregrine Ophthalmic

Ocuphire Pharma

HK inno.N

VivaVision Biotech

Qlaris Bio

Future Medicine

PolyActiva Pty Ltd

Theratocular Biotek

Whitecap Biosciences

JeniVision

AbbVie

Noveome Biotherapeutics

Key Products

DE-130A

PDP-716

NCX 470

PHP-201

Citicoline

TRS01

TC-002

T4032

Bremen

POLAT 001

Nyxol

IN-A010

VVN539

QLS-101

FM 101

PA5108

TO-O-1001

WB-007

JV-GL1

AGN-193408 SR

ST266