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Global Dry Eye Disease Drug Pipeline Research Report 2021 -

·5-min read

DUBLIN, August 05, 2021--(BUSINESS WIRE)--The "Dry Eye Disease - Pipeline Insight, 2021" clinical trials has been added to's offering.

This Dry Eye Disease - Pipeline Insight, 2021 provides comprehensive insights about 50+ 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.

Dry Eye Disease Emerging Drugs

OC-01: Oyster Point Pharma

OC-01, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, is being developed as a preservative-free nasal spray to treat the signs and symptoms of dry eye disease. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve which is accessible within the nose. Additionally, in preclinical models, it has been shown that OC-01 (varenicline) nasal spray may have the potential to modulate the amount of selected proteins, peptides, antibodies, hormones, enzymes or cytokines secreted from the lacrimal gland into the tear film and onto the ocular surface.

The U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021.

Reproxalap: Aldeyra Therapeutics

By inhibiting RASP, which are elevated in a variety of inflammatory diseases, reproxalap represents a novel mechanism for diminishing ocular inflammation in dry eye disease. In a number of clinical trials, reproxalap demonstrated consistent statistically significant and clinically relevant activity.

Additionally, reproxalap, if approved, has added the potential of being the only product that may be able to effectively treat dry eye disease, uniquely addressing the needs of the large underserved population that suffers from this disease. The drug is being evaluated in Phase III clinical trial to treat dry eye disease.

RGN-259: ReGenTree

RegeneRx drug candidate, RGN-259, is the subject of two Phase III clinical trials in the U.S. for patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication). ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc., specifically to develop RGN-259 in both the U.S. and Canada for ophthalmic indications.

ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. ReGenTree reports Positive Results from ARISE-3 Clinical Trial Using RGN-259 to treat Dry Eye Syndrome.

HL036: HanAll Biopharma

HL036, also known as Tanfanercept, is a new biological drug that can treat dry eye syndrome, which causes eye surface damage, irritation and foreign body sensation caused by the lack of tears or excessive evaporation. It has a new mechanism of inhibiting TNF? that causes inflammation in the eye. The company has been conducting the phase 3 clinical trial at 12 medical institutions in the U.S. through Ora, a local contract research organization.

NOV03: Novaliq

NOV03 (100% perfluorohexyloctane) is the first drug developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction in a highly effective way. NOV03 prevents excessive tear evaporation and has the ability to restores tear film balance. The investigational drug has a unique mode-of-action: It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.

In a Phase II study, NOV03 met its primary sign endpoint of improvement of total corneal fluorescein staining over control at eight weeks with high statistical significance (p < 0.001). In addition, NOV03 showed statistically significant and clinically meaningful improvement in a variety of symptoms over the entire duration of the trial. A Phase III study in the US is underway for NOV03.

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. 50+ 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. Preregistration include, Oyster Point Pharma.

Companies Mentioned

  • Aerie Pharmaceuticals

  • Aldeyra Therapeutics

  • Allergan

  • Allysta Pharmaceuticals

  • AxeroVision, Inc

  • Azura Ophthalmics

  • Bausch & Lomb Incorporated

  • BRIM Biotechnology

  • Cambium Medical Technologies

  • Chong Kun Dang Pharmaceutical

  • Clementia Pharmaceuticals

  • GL Pharm Tech Corporation

  • HanAll Biopharma

  • Huons

  • Kowa Research Institute, Inc.

  • Laboratorios Sophia S.A de C.V.

  • Mitotech, SA

  • Novaliq

  • Novartis

  • Ocular Therapeutix

  • Oyster Point Pharma, Inc.

  • Palatin Technologies

  • Redwood Pharma

  • RegeneRx Biopharmaceuticals

  • Samjin Pharmaceutical

  • Senju Pharmaceutical

  • SIFI SpA

  • Silk Technologies, Ltd.

  • Stuart Therapeutics

  • Sylentis, S.A.

  • Tarus Pharmaceuticals

  • TearSolutions

  • Topivert Pharma Ltd

  • VivaVision Biotech, Inc

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.


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

  • Parenteral

  • Intravenous

  • Subcutaneous

  • Topical

  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy

  • Product Type

The 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

For more information about this clinical trials report visit

View source version on

Laura Wood, Senior Press Manager

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