Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study
Abstract Introduction Immunosafe plasma rich in growth factors eye drops (is-ePRGF) have shown anti-inflammatory and regenerative effects on ocular surface diseases (OSD). However, medical or technical issues may preclude some patients from undergoing autologous blood extraction. We aimed to evaluat...
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Adis, Springer Healthcare
2025-07-01
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| Series: | Ophthalmology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40123-025-01211-1 |
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| author | Rosa Alvarado-Villacorta Jesús Merayo-Lloves Ronald M. Sánchez-Ávila Belén Alfonso-Bartolozzi Carlos Lisa Luis Fernández-Vega-Cueto José F. Alfonso Eduardo Anitua |
| author_facet | Rosa Alvarado-Villacorta Jesús Merayo-Lloves Ronald M. Sánchez-Ávila Belén Alfonso-Bartolozzi Carlos Lisa Luis Fernández-Vega-Cueto José F. Alfonso Eduardo Anitua |
| author_sort | Rosa Alvarado-Villacorta |
| collection | DOAJ |
| description | Abstract Introduction Immunosafe plasma rich in growth factors eye drops (is-ePRGF) have shown anti-inflammatory and regenerative effects on ocular surface diseases (OSD). However, medical or technical issues may preclude some patients from undergoing autologous blood extraction. We aimed to evaluate the safety and clinical outcomes of allogeneic is-ePRGF therapy for refractory OSD in real-world practice. Methods A single-center cohort was conducted involving consecutive patients with severe OSD nonresponsive to conventional therapy. All participants received allogeneic is-ePRGF derived from healthy family donors as compassionate treatment (one drop four times daily for 6 weeks per cycle), with a minimum follow-up of 3 months. Primary outcomes included symptom changes assessed by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE) questionnaires, resolution of persistent epithelial defects (PED), and adverse events (AE). Secondary outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), corneal staining, Schirmer I test, tear break-up time (BUT), conjunctival bulbar redness, and meibomian gland dysfunction (MGD). Multilevel mixed-effects models were used to account for intra-patient and inter-eye correlations. Results A total of 30 patients (58 eyes; mean age 53.4 ± 22.6 years; 50% female) were included. The most common diagnoses were severe dry eye disease and neurotrophic keratopathy, frequently associated with autoimmune/inflammatory conditions. Overall, 12 patients (40%) had previously received autologous therapies. Donors were primarily first-degree relatives. Median follow-up was 9 months (range 3‒30 months), with a mean of 6.2 ± 3 cycles. OSDI and SANDE scores significantly improved (p < 0.001). Among 12 cases with PED, 8 (67%) fully resolved. No AE occurred. BCVA (p = 0.010), Schirmer test, BUT, conjunctival bulbar redness, corneal staining, and MGD severity improved significantly (p < 0.001); IOP remained stable (p = 0.132). Conclusions Allogeneic is-ePRGF was a safe and effective alternative for refractory OSD when autologous sources were not available or suitable. Standardization of regulatory frameworks for allogeneic blood-based therapies is needed to support broader clinical adoption. |
| format | Article |
| id | doaj-art-59a424dc23ef4c2e9025a30b0fbb13c6 |
| institution | Kabale University |
| issn | 2193-8245 2193-6528 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Adis, Springer Healthcare |
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| series | Ophthalmology and Therapy |
| spelling | doaj-art-59a424dc23ef4c2e9025a30b0fbb13c62025-08-24T11:11:48ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282025-07-011492253228110.1007/s40123-025-01211-1Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational StudyRosa Alvarado-Villacorta0Jesús Merayo-Lloves1Ronald M. Sánchez-Ávila2Belén Alfonso-Bartolozzi3Carlos Lisa4Luis Fernández-Vega-Cueto5José F. Alfonso6Eduardo Anitua7Fundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaFundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaUniversidad de OviedoFundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaFundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaFundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaFundación de Investigación Oftalmológica, Instituto Universitario Fernández-VegaRegenerative Medicine Laboratory, Biotechnology Institute (BTI)Abstract Introduction Immunosafe plasma rich in growth factors eye drops (is-ePRGF) have shown anti-inflammatory and regenerative effects on ocular surface diseases (OSD). However, medical or technical issues may preclude some patients from undergoing autologous blood extraction. We aimed to evaluate the safety and clinical outcomes of allogeneic is-ePRGF therapy for refractory OSD in real-world practice. Methods A single-center cohort was conducted involving consecutive patients with severe OSD nonresponsive to conventional therapy. All participants received allogeneic is-ePRGF derived from healthy family donors as compassionate treatment (one drop four times daily for 6 weeks per cycle), with a minimum follow-up of 3 months. Primary outcomes included symptom changes assessed by Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE) questionnaires, resolution of persistent epithelial defects (PED), and adverse events (AE). Secondary outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), corneal staining, Schirmer I test, tear break-up time (BUT), conjunctival bulbar redness, and meibomian gland dysfunction (MGD). Multilevel mixed-effects models were used to account for intra-patient and inter-eye correlations. Results A total of 30 patients (58 eyes; mean age 53.4 ± 22.6 years; 50% female) were included. The most common diagnoses were severe dry eye disease and neurotrophic keratopathy, frequently associated with autoimmune/inflammatory conditions. Overall, 12 patients (40%) had previously received autologous therapies. Donors were primarily first-degree relatives. Median follow-up was 9 months (range 3‒30 months), with a mean of 6.2 ± 3 cycles. OSDI and SANDE scores significantly improved (p < 0.001). Among 12 cases with PED, 8 (67%) fully resolved. No AE occurred. BCVA (p = 0.010), Schirmer test, BUT, conjunctival bulbar redness, corneal staining, and MGD severity improved significantly (p < 0.001); IOP remained stable (p = 0.132). Conclusions Allogeneic is-ePRGF was a safe and effective alternative for refractory OSD when autologous sources were not available or suitable. Standardization of regulatory frameworks for allogeneic blood-based therapies is needed to support broader clinical adoption.https://doi.org/10.1007/s40123-025-01211-1Allogeneic blood-based eye dropsDry eye diseaseHemoderivativesOcular surface diseasePlasma rich in growth factorsPRGF |
| spellingShingle | Rosa Alvarado-Villacorta Jesús Merayo-Lloves Ronald M. Sánchez-Ávila Belén Alfonso-Bartolozzi Carlos Lisa Luis Fernández-Vega-Cueto José F. Alfonso Eduardo Anitua Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study Ophthalmology and Therapy Allogeneic blood-based eye drops Dry eye disease Hemoderivatives Ocular surface disease Plasma rich in growth factors PRGF |
| title | Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study |
| title_full | Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study |
| title_fullStr | Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study |
| title_full_unstemmed | Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study |
| title_short | Real-World Outcomes of Allogeneic Immunosafe Plasma Rich in Growth Factors Eye Drops for Refractory Ocular Surface Diseases: A Prospective Observational Study |
| title_sort | real world outcomes of allogeneic immunosafe plasma rich in growth factors eye drops for refractory ocular surface diseases a prospective observational study |
| topic | Allogeneic blood-based eye drops Dry eye disease Hemoderivatives Ocular surface disease Plasma rich in growth factors PRGF |
| url | https://doi.org/10.1007/s40123-025-01211-1 |
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