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Krytantek Ofteno®
Krytantek Ofteno® is a Small molecule drug developed by Laboratorios Sophia S.A de C.V.. It is currently in Phase 3 development for Glaucoma (intraocular pressure reduction). Also known as: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, timolol, dorzolamide, brimonidine.
Krytantek Ofteno is a topical ophthalmic formulation designed to reduce intraocular pressure in glaucoma by enhancing aqueous humor outflow or reducing aqueous humor production.
Krytantek Ofteno is a topical ophthalmic formulation designed to reduce intraocular pressure in glaucoma by enhancing aqueous humor outflow or reducing aqueous humor production. Used for Glaucoma (intraocular pressure reduction).
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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).
| 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 | Krytantek Ofteno® |
|---|---|
| Also known as | timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, timolol, dorzolamide, brimonidine |
| Sponsor | Laboratorios Sophia S.A de C.V. |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Krytantek Ofteno is developed by Laboratorios Sophia, a Mexican pharmaceutical company specializing in ophthalmologic treatments. The drug is in Phase 3 development for glaucoma management. While specific molecular targets are not publicly detailed, it is formulated as an eye drop for topical ocular administration to address elevated intraocular pressure, a key pathogenic factor in glaucoma.
Approved indications
- Glaucoma (intraocular pressure reduction)
Common side effects
Key clinical trials
- PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM) (PHASE3)
- Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension. (PHASE4)
- Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno® (PHASE1)
- Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK) (PHASE3)
- Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide (PHASE2)
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:
- Krytantek Ofteno® CI brief — competitive landscape report
- Krytantek Ofteno® updates RSS · CI watch RSS
- Laboratorios Sophia S.A de C.V. portfolio CI
Frequently asked questions about Krytantek Ofteno®
What is Krytantek Ofteno®?
How does Krytantek Ofteno® work?
What is Krytantek Ofteno® used for?
Who makes Krytantek Ofteno®?
Is Krytantek Ofteno® also known as anything else?
What development phase is Krytantek Ofteno® in?
Related
- Manufacturer: Laboratorios Sophia S.A de C.V. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma (intraocular pressure reduction)
- Also known as: timolol 0.5%, brimonidine 0.2%, dorzolamide 2%, timolol, dorzolamide, brimonidine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing