Dry Eye Disease - Pipeline Insight, 2024

This “Dry Eye Disease- Pipeline Insight, 2024” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Dry Eye Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also 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

Dry Eye Disease: Understanding

Dry Eye Disease: Overview

Dry eye disease (DED), also known as dry eye syndrome (DES), keratoconjunctivitis sicca (KCS), and keratitis sicca, is a multifactorial disease of the ocular surface due to a loss of homeostasis of the tear film. It often results in ocular symptoms and visual disturbance due to underlying tear film instability, ocular suface inflammation and damage, and neuorsensory abnormalities.

Tear hyperosmolarity and instabiliy are the principal components of the primary drivers of dry eye disease. The two major types of DED, aqueous deficient dry eyes (ADDE) and evaporative dry eyes (EDE), can both be related to tear hyperosmolarity and instability. In EDE, tear film lipid deficiency from meibomian gland dysfunction results in excessive evaporation of the tear film. This leads to tear hyperosmolarity in the presence of normal lacrimal function. In ADDE, reduced tear secretion from the lacrimal glands due to lacrimal gland damage (for exmaple, in Sjögren disease) leads to the hyperosmolarity of the tear film despite a normal evaporation rate of the tear film. The patient with dry eyes will typically complain of sensations of burning, grittiness, foreign body sensation and actual dryness. These symptoms are usually exacerbated by wind, air conditioning, prolonged staring (such as reading or computer use) and other conditions which contribute to a decrease in blink rate or an increase in evaporation rate. Dry eye can cause a scratchy feeling, like there’s something in eye, stinging or burning feelings in eye, red eyes, sensitivity to light, blurry vision, etc.

The accurate diagnosis and classification of DED is complicated by the heterogeneous nature of the disease and wide variations in symptoms. A number of clinical tests assessing signs of DED are available that can broadly be divided into either those that evaluate tear production/quality or those that assess the integrity of the ocular surface. However, there is lack of a single test that can be used to accurately assess disease progression or response to treatment. The clinical picture of DED is further complicated by the observation that changes in and severity of clinical signs often does not correspond to patient-reported symptoms. This may impact both the diagnosis and management of DED in clinical practice and the design and interpretation of clinical trials with sign and symptom endpoints.

The management of DED is highly complicated because of its multifactorial etiology associated with many mechanisms. Therefore, when making a diagnosis of dry eye, clinicians should clearly determine the underlying etiology, such as EDE or ADDE, which are the mechanisms that cause DED, and/or other ocular surface diseases, and they should administer relevant treatments accordingly. . Treatment planning based on treatment algorithms is done according to disease severity. Treatment planning based on treatment algorithms is done according to disease severity. However, due to the coexistence of many factors in DED, strictly adhering to the algorithm system does not always work.

Dry Eye Disease- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Dry Eye Disease pipeline landscape is provided which includes the disease overview and Dry Eye Disease treatment guidelines. The assessment part of the report embraces, in depth Dry Eye Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Dry Eye Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Dry Eye Disease R&D. The therapies under development are focused on novel approaches to treat/improve Dry Eye Disease.

Dry Eye Disease Emerging Drugs Chapters

This segment of the Dry Eye Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Dry Eye Disease Emerging Drugs

AR-15512: Alcon AR-15512 is an investigational eye drop currently in clinical development at Aerie as a potential treatment for the signs and symptoms of dry eye disease. It has not been approved by the US Food and Drug Administration (FDA). The active ingredient in AR-15512 is a proprietary small-molecule selective agonist of the transient receptor potential melastatin 8 (TRPM8) cold thermoreceptor, which represents a novel therapeutic target for dry eye. Currently, the drug is in Phase III stage of its development for the treatment of dry eyesdisease.

HL036: HanAll Biopharma HL036 (tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel, topical biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in ocular inflammation. The first Phase III clinical trial (VELOS-2) for dry eye disease was completed in the US. It is being developed in Phase III in China by Harbour BioMed, HanAll’s out-licensing partner for the greater Chinaregion.

OTX-DED: Ocular Therapeutix OTX-DED, is a low dose, intracanalicular insert of dexamethasone for the treatment of patients with episodic dry eye disease. OTX-DED is designed to release dexamethasone over a period of two to three weeks for the short-term treatment of the signs and symptoms of dry eye disease. OTX-DED may offer patients the opportunity to be treated with a physician-administered, preservative-free and hands-free steroid therapy. Currently, the drug is in Phase II stage of its development for the treatment of dry eyesdisease.

SY-201: Seinda Pharmaceuticals Y-201, which is being developed by Seinda Pharmaceutical, is under developmental Phase I/II for the treatment of dry eye disease. It is administered through ophthalmic route in the form of solution.

i VIEW 1001: IVIEW Therapeutics IVW-1001 is a TRPM8 receptor agonist which selectively activates TRPM8 receptors and their activation has the potential to reduce discomfort. Evidence from clinical studies showed that topical TRPM8 activation reduced eye discomfort and increased tear secretion in those with DED. In January 2023, i VIEW Therapeutics announced that the company completed a successful pre-IND meeting with FDA and received the agency’s full agreement on all CMC, non-clinical and clinical development plans to develop IVW-1001 for the treatment of sign and symptoms of dry eye disease (DED). The company is targeting to initiate Phase I/II clinical trials for dry eye patients in the endof2023.

Dry Eye Disease: Therapeutic Assessment

This segment of the report provides insights about the different Dry Eye Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Dry Eye Disease

• There are approx. 45+ key companies which are developing the therapies for Dry Eye Disease. The companies which have their Dry Eye Disease drug candidates in the most advanced stage, i.e. phase III include, Alcon.

Phases

This report covers around 50+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Dry Eye Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Dry Eye Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Dry Eye Disease therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Dry Eye Disease drugs.

Dry Eye Disease Report Insights

• Dry Eye Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Dry Eye Disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Dry Eye Disease drugs?
• How many Dry Eye Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Dry Eye Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Dry Eye Disease 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 Dry Eye Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Alcon
• HanAll Biopharma
• Ocular Therapeutix
• Seinda Pharmaceutical
• IVIEW Therapeutics
• Novaliq GmbH
• Kowa Company
• Seikagaku Corporation
• Aramis Biosciences
• Dreamhawk Vision Biotech, Inc.
• Taejoon Pharmaceutical
• Quorum Innovations
• Serentrix
• Noveome
• Allysta Pharmaceuticals
• BRIM Biotechnology
• Invirsa

Key Products

• AR-15512
• HL036
• OTX-DED
• SY-201
• i VIEW1001
• CyclASol
• K-161
• SI-614
• A197
• SHJ 002
• TJO-083
• Qi 401
• SER-114
• ST-266
• ALY 688
• BRM421
• INV-102

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