Pharmactive Biotech highlights saffron extract’s clinical efficacy in boosting vision health

Pharmactive Biotech Products’ latest nutraceutical solution, AffroEye, is pegged as a next-generation eye health ingredient made from saffron. Standardized to contain a potent 3.1–5% crocuvisalides, this “totum” complex of active molecules combines crocins for high antioxidant power and kaempferol glycosides to support a healthy inflammatory response. 

Nutrition Insight speaks to Ava Ghobadpour, business development manager at Pharmactive Biotech Products, about the ingredient’s provenance and clinical efficacy.

“The ingredient is made using our Crocuvis Cool Tech Process,” she details. “This proprietary, registered extraction technology uses low temperatures and zero chemicals to uniquely concentrate and stabilize these actives while using less energy than traditional methods.”

“In terms of AffronEye’s fingerprint profile, we ensure authenticity and consistency through a proprietary HPLC-DAD-MS [High-Performance Liquid Chromatography-Diode Array Detector-Mass Spectrometry] method to detect and standardize eight characteristic saffron compounds, including picrocrocin and seven crocin isomers, in every batch.”

Protecting retina cells

AffroEye’s efficacy is supported by a triple mechanism of action, comprising antioxidant, anti-inflammatory, and anti-apoptotic properties backed by in vivo research.

The solution demonstrated its efficacy in helping prevent retinal cell death. Research published in the International Journal of Molecular Sciences showed that AffronEye significantly reduces the death of retinal ganglion cells (RGCs) induced by ocular hypertension.

In this particular study, researchers induced ocular hypertension via laser surgery performed on mice to mimic the damage seen in glaucoma. It was the first to demonstrate these neuroprotective and anti-inflammatory effects in such a model.

AffroEye’s efficacy is supported by a triple mechanism of action, comprising antioxidant, anti-inflammatory, and anti-apoptotic properties.

Researchers noticed this neuroprotective effect up to seven days after laser induction. While untreated mouse eyes suffered a significant loss of retinal ganglion cells, those treated with saffron extract experienced no such loss.

Optimal anti-inflammatory results were observed on the third day, while the peak neuroprotective benefits — specifically the prevention of RGC death — were confirmed on the seventh day.

“For neuroinflammatory support, it reduces microglia infiltration (the migration of inflammatory immune cells into the retina) and decreases the morphological signs of microglial activation, such as increased soma size and process retraction,” highlights Ghobadpour.

Shielding retina from inflammatory damage

Further research in the Journal of Clinical Medicine showed that AffronEye prevents the harmful imbalance of retinal cytokines and growth factors in the eyes, effectively protecting the retina from inflammatory damage.

This trial also induced ocular hypertension in mice via laser surgery. Notably, in mice treated orally with the saffron extract standardized to 3.14% crocin, almost all the typical inflammatory changes triggered by the high eye pressure were absent.

The study identifies the optimal window for saffron’s anti-inflammatory benefits as one, three, and five days after ocular hypertension induction, with the greatest effect specifically on the first and third days.

In the complex neuroinflammatory process of glaucoma, high intraocular pressure typically forces retinal glial cells into a destructive “M1” state, where they release a flood of toxic chemicals that kill retinal ganglion cells and lead to blindness. 

However, the researchers discovered that saffron’s bioactive components, particularly crocetin, intervene by modulating the NF-κB inflammatory pathway and blocking the release of these harmful proinflammatory mediators.

New trending product formats

Ghobadpour also touches on unique trending product formats for Pharmactive’s eye wellness support ingredient.

“Lid mists — also known as eye sprays or liposomal mists — are the newest, unique, trending product format for eye wellness support. They have emerged as the new way to manage eye wellness because they solve the two biggest hurdles of traditional eye care: user error and evaporative dry eye,” she highlights.

“Our prediction for upcoming trending products would be eyelid serums that claim to penetrate the thin lid skin to deliver a solution directly to the local tissues. Instead of traditional drops, which many find uncomfortable, the treatment is sprayed over closed eyes to soothe the lid margin.”

Regulatory challenges

Ghobadpour underscores that the eye wellness space is currently one of the most scrutinized sectors, particularly in the EU. “Navigating the path from a high-quality botanical extract to a compliant, marketable ingredient requires more than just good science,” she notes.

Ghobadpour underscores that the eye wellness space is currently one of the most scrutinized sectors, particularly in the EU. “In Spain and the wider EU, eye wellness isn’t just about efficacy; it’s about traceability and claim substantiation. We didn’t just overcome these challenges by being compliant, but also, we did it by being transparent.”

Transitioning Pharmactive’s Spanish extract AffronEye from the EU to the North American market has required a complete recalibration of the company’s regulatory strategy.

“Several years ago, we moved beyond basic spectrophotometry. We implemented a Fingerprinting Strategy using HPLC and DNA barcoding to ensure the extract is 100% Crocus sativus [saffron] by adhering to ISO 3632 standards and providing transparent batches,” explains Ghobadpour.

She says the company turned a regulatory hurdle into a competitive advantage by enabling total traceability. Pharmactive’s team collaborates with customers to map out the “claims-to-process” pathway, she adds.

“Integration is more than just chemistry; it’s about market readiness. We carefully study our AffronEye ingredient by analyzing its behavior under different conditions to ensure these delicate compounds remain stable throughout different manufacturing processes, and the preservation of its characteristic ‘fingerprint.’”

Clinical results from previous trials have also demonstrated Affron’s potential to support individuals with mild depressive symptoms as well as post-workout recovery.