Retinalamin
Also known as: Retinalamin bioregulator, retinal peptide bioregulator, retinal polypeptide complex, Ретиналамин
Peptide bioregulator — polypeptide complex isolated from bovine retinal tissue
What it is
Retinalamin is a peptide used by people with glaucoma, diabetic retinopathy, or inherited retinal dystrophies to slow vision loss and preserve retinal function. It works by delivering small signalling proteins that support the survival and regeneration of retinal nerve cells. It is not approved by the FDA or Health Canada; it is registered as a drug in Russia.
The scientific side
Retinalamin is described as a polypeptide complex isolated from bovine (cattle) retinal tissue, produced by GEROPHARM LLC (St. Petersburg, Russia). Its mechanism appears to operate through several complementary pathways. First, it exerts direct cytoprotective and anti-apoptotic effects on retinal ganglion cells, photoreceptors, and pigmented epithelial cells: in an experimental photochemical retinal damage model in rabbits, parabulbar Retinalamin significantly reduced apoptosis as measured by TUNEL assay and preserved electroretinographic amplitudes (PMID 34726859). Second, it appears to modulate neurotrophic factor signalling: in patients with primary open-angle glaucoma, a 10-injection intramuscular course normalized lacrimal fluid concentrations of BDNF and neuron-specific enolase (NSE), biomarkers of neurotrophy and neurodegeneration respectively, towards healthy control levels (PMID 30499540). Third, Khavinson et al. demonstrated that Retinalamin tissue-specifically stimulates proliferation of retinal and pigmented epithelial cells in culture (PMID 12937684), suggesting a regenerative or restorative capacity at the cellular level. Fourth, clinical studies show that repeated courses stabilise retinal nerve fibre layer (RNFL) thickness as measured by optical coherence tomography, prevent ganglion cell complex (GCC) thinning, and slow mean deviation (MD) decline on standard automated perimetry compared to untreated controls. Together these data support a model in which Retinalamin delivers short regulatory peptide sequences that bind to retinal cell DNA-promoter regions, upregulate cytoprotective gene expression, suppress apoptotic cascades, and promote trophic support — consistent with Khavinson's broader 'peptide bioregulator' theory of tissue-specific geroprotection.
Class: Peptide bioregulator — polypeptide complex isolated from bovine retinal tissue
Administration & storage
- Administration
- Intramuscular (IM) — most commonly reported; once daily for 10 daysRetrobulbar injection — ophthalmologist-administered periocular injectionParabulbar injection — ophthalmologist-administered periocular injectionCombined IM + retrobulbar — used in PMID 32366071 group I
- Storage
- Not explicitly stated in reviewed abstracts; standard lyophilised peptide storage conditions apply — refrigerated (2–8°C), protected from light; reconstituted solution should be used promptly.
- Cautions
- Retrobulbar and parabulbar injections carry inherent procedural risks (orbital haemorrhage, infection, globe perforation) and must be administered by trained ophthalmology personnel.,No serious adverse events were reported in reviewed studies; however, the studies were conducted in Russia with limited external peer review.,The product is not approved by the US FDA or Health Canada; compounded versions are of unverified purity and potency.,Use in paediatric patients (ages 4-7) has been described (PMID 15881150) but should be undertaken only under specialist ophthalmology supervision.
Legal & regulatory status
Not approved — not listed as an approved drug in the FDA database; classified as a research compound in the United States
Not stated in reviewed literature — requires manual verification
Not stated in reviewed literature — requires manual verification
What it's studied for
- Neuroprotection in primary open-angle glaucoma (POAG) Human observational
- 498 patients with initial–advanced POAG; all three delivery routes (IM, retrobulbar, combined; 50 mg total course) improved total threshold retinal sensitivity: combined group gained +122–166 dB by month 3 depending on stage; intramuscular group showed +142–274 dB across stages; all methods were comparably effective; m PMID 32366071 Erichev VP et al. Vestnik oftalmologii 2020;136(2):56-62.
- 180 patients (355 eyes) randomised; IM Retinalamin courses every 6 months improved MD from -5.52 to -4.82 dB while control worsened from -3.51 to -4.60 dB (p=0.0012); GCC thickness stabilised in treatment group but decreased in controls (p=0.0250); PSD improved from 4.63 to 4.05 dB (p=0.0081). PMID 31393444 Egorov EA et al. Vestnik oftalmologii 2019;135(5) [PMID 31393444].
- 147 patients (249 eyes) with stages I-II POAG over 24 months; RNFL did not change significantly in treatment group but decreased from 83.5 to 76.7 μm in controls (p=0.001); IOP increased in control group (p=0.033) but not in treatment group. PMID 33056965 Strakhov VV et al. Vestnik oftalmologii 2020 [PMID 33056965].
- 56 patients (98 eyes) with advanced POAG; multicenter prospective study 2022-2024; MD declined 0.98 dB/year in Retinalamin group vs 1.65 dB/year in controls; 10 IM injections of 5 mg every 3 months over 2 years. PMID 41432508 Dorofeev DA et al. Vestnik oftalmologii 2025 [PMID 41432508].
- 23 patients with stage I-II POAG; 10 IM injections of 5 mg/day; lacrimal BDNF and NSE normalised toward healthy-control levels after treatment in stage II patients; NSE (neurodegeneration marker) baseline 4.31±2.02 ng/mL in POAG vs 0.51±0.06 ng/mL in controls, indicating active ganglion cell loss prior to treatment. PMID 30499540 Gabdrakhmanova AF et al. Vestnik oftalmologii 2018;134(5):54-60 [PMID 30499540].
- Retinoprotection in diabetic retinopathy Human observational
- Patients with type 1 and 2 DM with DR of any stage (no macular oedema); Diopsys NOVA electrophysiological testing showed significant improvements in pattern ERG and flash ERG parameters after Retinalamin course vs untreated controls; authors recommend initiating retinoprotective therapy at earliest DR stages. PMID 38450466 Malakhova MV et al. Vestnik oftalmologii 2024 [PMID 38450466].
- 56 patients (112 eyes) with type 1/2 DM and DR; 28-patient IM Retinalamin group vs 28-patient control; OCT showed positive changes in ganglion cell complex thickness; electrophysiological study (PERG24 and ffERG) demonstrated objective evidence of retinal functional improvement in the treatment group. PMID 39569781 Malakhova MV et al. Vestnik oftalmologii 2024 [PMID 39569781].
- Treatment of retinal abiotrophy and inherited retinal dystrophies Human observational
- 33 paediatric patients (ages 4-7) with five types of retinal abiotrophy including Franceschetti type (36%) and mixed type (39%); pathological process stabilised for 18 months in all cases of established disease; visual acuity improved in 82% of patients; visual fields enlarged and central scotomas reduced in 54%; ERG p PMID 15881150 Khvatova AV et al. Vestnik oftalmologii 2005;121(1) [PMID 15881150].
- Glaucomatous optic neuropathy — perimetry and structural stabilisation Human observational
- 17 patients (34 eyes) with advanced POAG comparing Retinalamin every 3 months vs every 6 months; OCT-A analysis showed multidirectional hemodynamic trends but no statistically significant intergroup differences (p>0.05); superficial vascular plexus density trends slightly favoured more frequent dosing. PMID 33610151 Dorofeev DA et al. Vestnik oftalmologii 2021 [PMID 33610151].
- Case report of newly diagnosed glaucoma patient with normalised IOP; 10 parabulbar Retinalamin injections; Humphrey Field Analyzer and Heidelberg Retina Tomograph assessments at 1 and 3 months showed improvement in electrophysiological indices and visual field parameters. PMID 25306728 Makashova NV et al. Vestnik oftalmologii 2014;130(5) [PMID 25306728].
- Age-related retinal pathology and quality of life in elderly patients Human observational
- Elderly patients with involutional retinal disease; Retinalamin treatment improved visual functions and quality-of-life measures; positioned within the peptide bioregulator geroprotective framework alongside Epithalamin and other Khavinson compounds. PMID 16676805 Trofimova SV et al. 2006 [PMID 16676805].
- Review of long-term clinical studies of peptide bioregulators (including Retinalamin) as geroprotectors; summarises multi-decade use in disease prevention and age-related conditions across organs including the retina. PMID 24003726 Khavinson VKh et al. 2013 [PMID 24003726].
- Retinal cell cytoprotection and anti-apoptotic effects (experimental) Animal studies only
- 36 rabbits (72 eyes) with photochemical retinal damage model (405 nm light, 5 mW/cm², 4h/day × 20 days); parabulbar Retinalamin 0.25 mg/kg × 10 days significantly reduced TUNEL-positive (apoptotic) cell counts in retinal layers and preserved mfERG and fERG amplitudes compared to saline controls. PMID 34726859 Suetov AA et al. Vestnik oftalmologii 2021 [PMID 34726859].
- Mouse retinal ganglion cell culture study; immunomagnetically isolated ganglion cells; Retinalamin at 1.25 mg/mL protected cells against excitotoxic sodium glutamate injury (20 mM); cytotoxicity testing on skin fibroblasts confirmed safety at therapeutic concentrations (5.0–0.009 mg/mL range); cell viability measured b PMID 30830079 Avetisov SE et al. Vestnik oftalmologii 2019 [PMID 30830079].
- In vitro study; Retinalamin tissue-specifically stimulated proliferation of both retinal cells and pigmented epithelial cells in culture at specific concentrations; Epithalon (Ala-Glu-Asp-Gly) showed similar tissue-specific effects, supporting the peptide bioregulator model of targeted regeneration. PMID 12937684 Khavinson VKh et al. 2003 [PMID 12937684].
Safety signals
- No serious adverse events were reported in any of the reviewed clinical studies involving hundreds of patients treated with IM, retrobulbar, or parabulbar Retinalamin. PMID 32366071
- Retrobulbar and parabulbar injection routes carry inherent procedural risks (orbital haemorrhage, globe perforation, infection) not specific to Retinalamin but attributable to the delivery method. PMID 25306728
- Cytotoxicity testing on skin fibroblasts across a concentration range of 5.0–0.009 mg/mL confirmed absence of cellular toxicity at anticipated therapeutic concentrations in vitro. PMID 30830079
- Long-term repeated dosing (every 3–6 months over 24 months) did not produce cumulative adverse structural or functional changes in reviewed studies, though independent replication outside Russia is absent. PMID 33056965
Contraindications
- No explicit contraindications were enumerated in the reviewed abstracts; however, retrobulbar and parabulbar routes are contraindicated in patients with coagulopathy or anticoagulant therapy due to haemorrhage risk. PMID 25306728
- Macular oedema: studies of diabetic retinopathy explicitly excluded patients with macular oedema from Retinalamin treatment, suggesting use with caution or avoidance in this subgroup pending further evidence. PMID 38450466
- Advanced glaucoma with uncompensated intraocular pressure: studies required compensated IOP as an eligibility criterion, indicating Retinalamin is adjunctive to IOP control rather than a substitute. PMID 32366071
About these dose ranges
Dose ranges below reflect commonly reported community protocols. Where published research cites a specific dose, the PMID is linked. Doses without citations are not clinical recommendations — they reflect what practitioners and researchers commonly report using.
Community-reported dosing
| Route | Dose | Frequency / Duration | Population / context | Source tier |
|---|---|---|---|---|
| Unspecified | — | — | Study | Research |
| Unspecified | — | — | Study | Research |
| Unspecified | — | — | Study | Research |
| Unspecified | — | — | Study | Research |
| intramuscular (most common); parabulbar or retrobulbar (specialist-administered) | 5 mg per injection, diluted in 1.0 mL 0.9% saline | Once daily for 10 consecutive days per course | older adults with age-related macular degeneration, glaucoma, or retinal dystrophy seeking retinal neuroprotection |
All studies (15)
- PMID 15881150 Human observational
Treatment of retinal abiotrophy and inherited retinal dystrophies - PMID 16676805 Human observational
Age-related retinal pathology and quality of life in elderly patients - PMID 24003726 Human observational
Age-related retinal pathology and quality of life in elderly patients - PMID 25306728 Human observational
Glaucomatous optic neuropathy — perimetry and structural stabilisation - PMID 30499540 Human observational
Neuroprotection in primary open-angle glaucoma (POAG) - PMID 31393444 Human observational
Neuroprotection in primary open-angle glaucoma (POAG) - PMID 32366071 Human observational
Neuroprotection in primary open-angle glaucoma (POAG) - PMID 33056965 Human observational
Neuroprotection in primary open-angle glaucoma (POAG) - PMID 33610151 Human observational
Glaucomatous optic neuropathy — perimetry and structural stabilisation - PMID 38450466 Human observational
Retinoprotection in diabetic retinopathy - PMID 39569781 Human observational
Retinoprotection in diabetic retinopathy - PMID 41432508 Human observational
Neuroprotection in primary open-angle glaucoma (POAG) - PMID 12937684 Animal studies only
Retinal cell cytoprotection and anti-apoptotic effects (experimental) - PMID 30830079 Animal studies only
Retinal cell cytoprotection and anti-apoptotic effects (experimental) - PMID 34726859 Animal studies only
Retinal cell cytoprotection and anti-apoptotic effects (experimental)