Last reviewed 2026-04-23 · How we verify

MIM-D3 Ophthalmic Solution

Mimetogen Pharmaceuticals USA, Inc. · Phase 3 active Small molecule

MIM-D3 Ophthalmic Solution is a small molecule Small molecule drug developed by Mimetogen Pharmaceuticals USA, Inc.. It is currently in Phase 3 development for Treatment of Leber congenital amaurosis due to RPE65 mutations. Also known as: Tavilermide Ophthalmic Solution.

MIM-D3 Ophthalmic Solution is a small molecule that targets the rhodopsin kinase (GRK1) to treat retinal diseases.

MIM-D3 Ophthalmic Solution is a small molecule that targets the rhodopsin kinase (GRK1) to treat retinal diseases. Used for Treatment of Leber congenital amaurosis due to RPE65 mutations.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MIM-D3 Ophthalmic Solution
Also known as	Tavilermide Ophthalmic Solution
Sponsor	Mimetogen Pharmaceuticals USA, Inc.
Drug class	small molecule
Target	GRK1
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	Phase 3

Mechanism of action

By inhibiting GRK1, MIM-D3 Ophthalmic Solution reduces the degradation of rhodopsin, a key protein in the visual transduction pathway, thereby preserving vision in patients with retinal diseases.

Approved indications

Treatment of Leber congenital amaurosis due to RPE65 mutations

Common side effects

Eye irritation

Key clinical trials

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:

MIM-D3 Ophthalmic Solution CI brief — competitive landscape report
MIM-D3 Ophthalmic Solution updates RSS · CI watch RSS
Mimetogen Pharmaceuticals USA, Inc. portfolio CI

Frequently asked questions about MIM-D3 Ophthalmic Solution

What is MIM-D3 Ophthalmic Solution?

MIM-D3 Ophthalmic Solution is a small molecule drug developed by Mimetogen Pharmaceuticals USA, Inc., indicated for Treatment of Leber congenital amaurosis due to RPE65 mutations.

How does MIM-D3 Ophthalmic Solution work?

MIM-D3 Ophthalmic Solution is a small molecule that targets the rhodopsin kinase (GRK1) to treat retinal diseases.

What is MIM-D3 Ophthalmic Solution used for?

MIM-D3 Ophthalmic Solution is indicated for Treatment of Leber congenital amaurosis due to RPE65 mutations.

Who makes MIM-D3 Ophthalmic Solution?

MIM-D3 Ophthalmic Solution is developed by Mimetogen Pharmaceuticals USA, Inc. (see full Mimetogen Pharmaceuticals USA, Inc. pipeline at /company/mimetogen-pharmaceuticals-usa-inc).

Is MIM-D3 Ophthalmic Solution also known as anything else?

MIM-D3 Ophthalmic Solution is also known as Tavilermide Ophthalmic Solution.

What drug class is MIM-D3 Ophthalmic Solution in?

MIM-D3 Ophthalmic Solution belongs to the small molecule class. See all small molecule drugs at /class/small-molecule.

What development phase is MIM-D3 Ophthalmic Solution in?

MIM-D3 Ophthalmic Solution is in Phase 3.

What are the side effects of MIM-D3 Ophthalmic Solution?

Common side effects of MIM-D3 Ophthalmic Solution include Eye irritation.

What does MIM-D3 Ophthalmic Solution target?

MIM-D3 Ophthalmic Solution targets GRK1 and is a small molecule.

Drug class: All small molecule drugs
Target: All drugs targeting GRK1
Manufacturer: Mimetogen Pharmaceuticals USA, Inc. — full pipeline
Therapeutic area: All drugs in Ophthalmology
Indication: Drugs for Treatment of Leber congenital amaurosis due to RPE65 mutations
Also known as: Tavilermide Ophthalmic Solution

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing