Last reviewed 2026-04-22 · How we verify

Rohto (r) Hydra

ORA, Inc. · FDA-approved active Small molecule

Rohto (r) Hydra is a Ophthalmic lubricant / Artificial tear Small molecule drug developed by ORA, Inc.. It is currently FDA-approved for Dry eye syndrome / Dry eye disease. Also known as: Rohto Hydra.

Rohto Hydra is an ophthalmic lubricant that provides moisture and relief to dry eyes by forming a protective hydrating layer on the ocular surface.

Rohto Hydra is an ophthalmic lubricant that provides moisture and relief to dry eyes by forming a protective hydrating layer on the ocular surface. Used for Dry eye syndrome / Dry eye disease.

At a glance

Generic name	Rohto (r) Hydra
Also known as	Rohto Hydra
Sponsor	ORA, Inc.
Drug class	Ophthalmic lubricant / Artificial tear
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	FDA-approved

Mechanism of action

This over-the-counter eye drop product works as an artificial tear substitute, delivering hydrating agents and lubricants to the cornea and conjunctiva. It helps reduce symptoms of dry eye disease by maintaining tear film stability and protecting the eye surface from further desiccation and irritation.

Approved indications

Dry eye syndrome / Dry eye disease

Common side effects

Temporary blurred vision
Eye irritation
Allergic reaction (rare)

Key clinical trials

Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra) (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Rohto (r) Hydra CI brief — competitive landscape report
Rohto (r) Hydra updates RSS · CI watch RSS
ORA, Inc. portfolio CI

Frequently asked questions about Rohto (r) Hydra

What is Rohto (r) Hydra?

Rohto (r) Hydra is a Ophthalmic lubricant / Artificial tear drug developed by ORA, Inc., indicated for Dry eye syndrome / Dry eye disease.

How does Rohto (r) Hydra work?

Rohto Hydra is an ophthalmic lubricant that provides moisture and relief to dry eyes by forming a protective hydrating layer on the ocular surface.

What is Rohto (r) Hydra used for?

Rohto (r) Hydra is indicated for Dry eye syndrome / Dry eye disease.

Who makes Rohto (r) Hydra?

Rohto (r) Hydra is developed and marketed by ORA, Inc. (see full ORA, Inc. pipeline at /company/ora-inc).

Is Rohto (r) Hydra also known as anything else?

Rohto (r) Hydra is also known as Rohto Hydra.

What drug class is Rohto (r) Hydra in?

Rohto (r) Hydra belongs to the Ophthalmic lubricant / Artificial tear class. See all Ophthalmic lubricant / Artificial tear drugs at /class/ophthalmic-lubricant-artificial-tear.

What development phase is Rohto (r) Hydra in?

Rohto (r) Hydra is FDA-approved (marketed).

What are the side effects of Rohto (r) Hydra?

Common side effects of Rohto (r) Hydra include Temporary blurred vision, Eye irritation, Allergic reaction (rare).

Drug class: All Ophthalmic lubricant / Artificial tear drugs
Manufacturer: ORA, Inc. — full pipeline
Therapeutic area: All drugs in Ophthalmology
Indication: Drugs for Dry eye syndrome / Dry eye disease
Also known as: Rohto Hydra
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Pricing: Rohto (r) Hydra cost, discount & access