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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PROBIOTEARS (Probiotic-based Ophtalmologic treatment for Bacterial and Allergic Conjunctivitis)

Teaser

Summary

Allergic conjunctivitis, one of the most common symptoms of allergy, affects more than 1100 million people throughout the world, while infectious bacterial conjunctivitis represents also a significant health problem and accounts for an estimated 1-1.5% of primary-care consultations. Currenlty, the market for bacterial and allergic conjunctivitis is mainly covered by antibiotic eye drops and ointments, which have undesired and unspecific effects in the conjunctival microbiota. Antibiotics perturbate commensal microbial communities, eradicating also beneficial species, and contribute to increase the antibiotic resistances developed by several pathogenic strains. Other drugs used to treat conjunctivitis have also undesired side effects and are not useful as an immediate solution, as their effect is delayed more than two weeks after starting the treatment.
AB-BIOTICS, a company with a broad expertise in the development of functional ingredients for applications in the pharmaceutical industry, has developed an innovative solution that overcomes the main limitations of the existing treatments. It is based on the use of probiotics, live micro-organisms which allow a fast and stable reestablishment of a healthy microbiota in the eye conjunctiva. . This new treatment provides (i) faster anti-inflammatory and anti-histaminic effects that can alleviate the symptoms of allergic conjunctivitis; (ii) antagonism to pathogens with no resistance risks; (iii) protection against future or recurrent infections through a healthy microbiota ecosystem; and (iv) avoidance of common side effects such as rise in intraocular pressure or rebound vasodilatation.
The effects of the selected probiotic strains have been validated through functional in vitro and in vivo tests and its safety for ocular application has also been assesed in toxicity trials in animal models. The industrial scaling up of the strain has already been achieved and now the future product is ready for galenic formulation.
Thus, the main objective of this project is now to deeply analyse the market opportunities for this innovative treatment for allergic and bacterial conjunctivitis, and to determine the key steps to bring it to the market within the next 2 years. The objectives for the feasibility study presented in this proposal have been:
â€¢ Assess the interest of the project for clinical ophthalmologists and users or patients associations through discussions with selected key-opinion leaders.
â€¢ Define the most adequate formula for ophthalmic use with the help of these selected experts, in order to start the galenic development of the product.
â€¢ Assure the IPR protection of the product through a Patent strategic planning.
â€¢ Perform a deeper market and competitor analysis to assess the market possibilities and niche opportunities.
â€¢ Identify and select the key partners to perform the required Supportive Clinical Trials during phase 2.
â€¢ Assess the Regulatory Requirements for the new product and prepare the pertinent submissions.
With Probiotic-based Ophtalmologic treatment for Bacterial and Allergic Conjunctivitis, AB-BIOTICS wants to establish a solid high-potential innovation project aligned to the enterprise strategy and to reinforce its European and global dimension. Moreover, the company expects to obtain an EBITDA of 2,14 Mâ‚¬ and to generate 3 new high qualified job positions from now to 2019.

Work performed

AB-Biotics (http://www.ab-biotics.com/) has developed an innovative solution based on the use of probiotics in eye drops that overcomes these limitations, re-establishing a healthy ocular microbiota to treat and prevent these conditions. Although the effects of the selected probiotic have been validated though functional in vitro and in vivo tests, a prospection of key-opinion leaders, and a market and competitor analysis were done to define the most adequate formula for ophthalmic use.
ABB developed a preliminary study of the acceptance of the product in final consumers and key opinion leaders through on-line surveys, personal interviews, teleconferences and focus groups. All these studies were carried out in Spain and in Italy, which is a country with a long tradition in probiotic consumption.
The results show that the key pathologies identified as targets of the product have a high incidence in the population. This, together with a growth in the turnover of 7% CAGR in the probiotic market in the upcoming years, gives rise to a key synergy in the viability of the product.
More than 700 responses given by consumers in the surveys concluded a high acceptance of the use of probiotics in the eye (83-85%) and the payment of the established price (73-77%), despite of lack of knowledge of probiotics in general population. Between 19-27% of the respondents were users of ophthalmic drops.
The opinions of 8 ophthalmologists and a primary care physician and two pharmacists were collected through personal interviews and a focus group, with no differences between countries. The expertsâ€™ opinion was that they would prescribe and/or recommend the product once the tolerance and effectiveness have been checked in clinical trials. The formula preferred by specialists and consumers is single-dose drops without preservatives. The experts added two more pathologies in which the product could act (blepharitis and dry eye) and it was recommended for daily use as a prevention.
In conclusion, even though the price is higher than most eye drops on the market and clinical studies are needed, its high acceptance among consumers and specialists as a treatment and prevention product makes PROBIOTEARS a viable product in the ophthalmic market.

Final results

PROBIOTEARS intends to deliver the first probiotic-based treatment for conjunctivitis. This new product addresses a limitation existing both at European and Global levels, as it is the topical treatment of conjunctivitis without side effects.
With respect to allergic conjunctivitis, the innovative feature of our approach represents the fast inmuno-modulatory response that probiotics can achieve in comparison to the existing antiallergic treatments available, such as mast cell stabilizers or inmunosupressants. In addition, the anti-inflammatory and anti-allergic effects of our probiotic strain are widely proven. The dosage pattern of probiotics also provides an advantage as it can be formulated to achieve a unique administration per day instead of 2-4 times daily or even administration patterns of every 4 hours.
The main novelty of the treatment of bacterial conjunctivitis based on live probiotics is that it modulates the healthy microbiota, targeting in a specific way the pathogenic strains and interacting positively with the rest of the ecosystem. The dysbiosis caused by antibiotics may cause secondary complications due to pathogens overgrowth or alteration of the immunomodulatory pathways where the microbiota is involved. Probiotics not only overcome these complications but also provide an anti-inflammatory and anti-histaminic effect in a same API.
In addition, probiotics for ocular treatment of conjunctivitis avoid the side effects of current treatments, which in some cases may cause vision-threatening or severe systemic complications (see table 1). Furthermore, probiotics are compatible with the use of all types of contact lenses, specially contact lenses for long-term use, as the eye might be more exposed to infection due to hygienic issues in the lenses daycare. Probiotics can modulate the biofilm formation on the lenses towards a beneficial biofilm and preventing the overgrowth of pathogens. This represents a relevant advantage given that most of the existing ocular drugs are not compatible with contact lenses and wearers need to stop their use during treatment.
Finally, this novel approach can be useful to reduce the cost of the full treatment for patients and for Health Institutions. Existing therapies are long-term based and require weeks and sometimes months of treatment to reach the desired effect, while a probiotic therapy needs a few days or even hours to show an antiallergic effect. In some countries (e.g. Spain) inmunosupressors for ocular application are only accepted as compassive use and upon personalized formulation, with the high cost that this represents, whereas in other countries (e.g. Germany), the price of a monodose package of 30x0.3mL oscillates around 110â‚¬. Regarding cheaper treatments as antibiotic or anti-inflammatories, PROBIOTEARSâ€™ improved features justify a similar or even higher price, since the probiotic eye-drops or ointment assembles the antagonism against pathogens with the anti-inflammatory, anti-histaminic and inmuno-modulating effects.
ABB, in this first phase of the PROBIOTEARS project, has conducted a feasibility study for this innovative product that intends to become an advance in the state of the art in ocular treatments by the application of probiotics. The main objective that AB BIOTICS considers after this first phase is to apply to a second one to make the product reach the market.