SIFI SpA

CATANIA, Italy, Sept. 6, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, is pleased to announce that it will present two product innovations and new scientific data during the upcoming Congress of The European Society of Cataract and Refractive Surgeons (ESCRS) which will take place from September 6-10 in Barcelona (Spain). "SIFI is pioneering the integration of wavefront technology with ocular surface management technologies to advance the standard of care in refractive cataract surgery. By tailoring intraocular lens optics and ocular surface treatments, our solutions allow patients to achieve superior quality of vision," said Maria Cristina Curatolo, SIFI's Executive Director of Innovation and Medical Science. Two new products will be introduced: A new version of its EVOLUX extended monofocal intraocular lens (IOL) with an improved injection technology, allowing a smoother delivery and the freedom to choose between a push or screw technique; A new IOL calculator based on the Hoffer QST and Næser-Savini formulas, allowing a more precise calculation of spherical and cylindrical powers, also thanks to the use of artificial intelligence. A total of five podium presentation and five e-Posters will feature clinical outcomes on SIFI's solutions for cataract refractive surgery and ocular surface disease, such as EVOLUX, the presbyopia-correcting WELL FUSION system and the artificial tear Eyestil SYNFO. The schedule of scientific presentations is as follows: Presented Posters on Sunday September 8th (14:15-15:45 | Room: Hall 6 & 7 - Pod 1) Visual Performance, Subjective Satisfaction And Quality Of Life Effect Of A New Extended Monofocal Intraocular Lens (Iol) (Pagnacco C.); Multicentric Clinical Investigation On The Use Of Preservative- Free Ophthalmic Solution Based On Sodium Hyaluronate, Osmoprotectants, And Xanthan Gum In The Treatment Of Eye Discomfort, Particularly In Dry Eye (Molero-Senosiain M.); Visual and Refractive Outcomes after Implantation Of An Extended Monofocal Non-Diffractive Hydrophobic Intraocular Lens (Romualdi G.); Intermediate visual acuity comparison of two non-diffractive enhanced monofocal intraocular lenses (Rotter A.). Free Paper Session on Tuesday 10th (11:00-12:30 | Room: Free paper podium 1) Visual Performance, Subjective Satisfaction And Quality Of Life Effect After Bilateral Implantation Of Extended Depth Of Focus Intraoular Lens (Edof IOL) Compared To Trifocal IOL: A Randomized Clinical Trial (Pagnacco C.). On Monday September 9th (13.00-14.00 - Room 8.10) SIFI will hold a Satellite Symposium "Ultimate Vision: Mastering Sight with Wavefront Engineering and Innovative Ocular Surface Management" featuring clinical updates from Dr. G. Savini, Prof. O. Findl, Dr. K. Gabric, Prof. E. Pedrotti and Prof. R. Mencucci. The list of e-Posters includes: Functional outcomes of a new enhanced monofocal IOL (Savini G. – poster ID PO323) Long Term Visual Outcomes of an Extended Monofocal Intraocular Lens (EVOLUX® ) after Cataract Surgery (Caparas V. – poster ID PO347) Visual Performance Of A New Advanced Monofocal Iol - Sifi Evolux (Gabrić K. – poster ID PO330) Evaluation Of Binocular Vision And Subjective Photic Disturbances After The Implantation Of Intraocular Lenses Between The Sifi Well Fusion Edof System And Three Trifocal Iol (Physiol Finevision, Alcon Clareon Panoptix And Ast Asqelio Trifocal) (Castanera D. – poster ID PO574) Estimated Visual Acuity And Clinical Validation For Three IOLs Based On Wavefront Engineering Technology (Vacalebre M. – poster ID PO592) ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at

AKANTIOR® (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis CATANIA, Italy, Aug. 26, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced the European Commission has approved AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age, confirming the orphan status of the product. AKANTIOR is the first and only approved therapy for people suffering from AK in Europe.  AK is an ultra-rare, severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. AK is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers. "Today's approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development," said Fabrizio Chines, Chairman and CEO of SIFI. "For the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA." "AKANTIOR, when used as monotherapy with the trial's treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease," stated Professor John Dart, of Moorfields Eye Hospital and the UCL Institute of Ophthalmology, who was Principal Investigator of the Phase III ODAK trial. "After 15 years of research and effort development by SIFI, culminating in the pivotal Phase III clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis. This breakthrough offers significant improvement over current treatment options and has the potential to prevent blindness and save eyes. As the only approved therapy, it has been recommended for use with the detailed treatment delivery protocol used in the Phase 3 trial, which eliminates the need for the variable individualized treatment delivery currently used for patients, providing an effective standardized approach that can be followed by any clinician and which has been shown to be effective, not only in the Trial, but also in the current compassionate use program outside the more stringent Trial setting." "With the approval of AKANTIOR, AK patients (also known as AK Warriors) are now one step closer to having access to the best possible treatment in the EU. This milestone represents a significant step towards providing fair healthcare to all AK Warriors, giving them hope for a brighter future," commented Juliette Vila Sinclair Spence , a rare disease patient advocate and the Chairwoman and Founder of AK Eye Foundation – the first global foundation dedicated exclusively to this condition. In Europe, SIFI plans to initiate its first commercial launch in Germany during the last quarter this year, followed by additional markets based on local regulatory, healthcare technology assessment and reimbursement process timelines, including France, Italy, Romania, Spain, United Kingdom and Turkey addressing a total population of 430 million, and by Avanzanite, its commercial partner, in other European Countries addressing an additional population of 180 million. Based on scientific publications, the incidence of acanthamoeba keratitis is estimated at 1 to 4 patients per million inhabitants. ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. The European Commission confirmed the orphan status of the product. The FDA granted SIFI Orphan Drug Designation for the treatment of acanthamoeba keratitis. ABOUT Acanthamoeba Keratitis (AK): AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research and development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at .

ACI SANT'ANTONIO, Italy, July 22, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, is pleased to announce that the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA) has issued a positive opinion concerning Orphan Drug Designation (ODD) for polihexanide in the treatment of fungal keratitis. This designation follows the positive opinion of Committee for Human Medicinal Products (CHMP) adopted in May and the COMP positive opinion dated March 30 of this year for the medicinal product AKANTIOR® (polihexanide 0.08%) in the treatment of acanthamoeba keratitis. SIFI expects to receive the decision of the European Commission (EC) for marketing authorization in August. Polihexanide received an ODD in fungal keratitis from the US Food and Drug Administration (FDA) in February 2022. Fungal keratitis, a severe infection of the cornea caused by fungi such as Fusarium, Aspergillus, and Candida species, is a significant cause of ocular morbidity and unilateral blindness worldwide1. Although rare, this condition can lead to substantial vision loss if not treated promptly. Currently, no approved treatments exist for fungal keratitis in Europe, Japan, Asia, and most other regions globally. COMP's positive opinion concerning ODD for fungal keratitis is based on SIFI's in vitro, ex vivo and in vivo studies on standardized strains, demonstrating the efficacy of polihexanide against the most recurring species in fungal keratitis, such as Fusarium, Candida and Aspergillus. In vivo study were performed in collaboration with Gazi University (Ankara, Turkey). Additional studies on human ocular isolates are ongoing to potentially confirm the efficacy of polihexanide in fungal keratitis. SIFI plans to initiate clinical trials in patients affected by fungal keratitis in 2025. The company will seek Contract Research Organization (CRO) pitches for a Phase II clinical trial in Q4 2024. SIFI will focus its clinical development program on two major geographies, such as the USA and Europe. A potential CRO partner should demonstrate extensive experience in ophthalmology and rare diseases, and a global presence. "As we are preparing to launch AKANTIOR® (polihexanide 0.08%) in acanthamoeba keratitis across Europe, this COMP positive opinion concerning ODD for fungal keratitis reinforces our commitment to further invest on polihexanide and develop it in such rare disease where there is a high unmet medical need," said Fabrizio Chines, Chairman and CEO of SIFI. "We are eager to advance into the clinical development after encouraging preclinical data and double down on our efforts to develop therapeutic solutions for ophthalmic rare diseases." ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information is available at . ABOUT AKANTIOR®: AKANTIOR® (polihexanide 0.08%) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. The EC and the FDA granted SIFI Orphan Drug Designation in the treatment of acanthamoeba keratitis. CHMP opinion was received in May, EC decision is expected in August 2024. In addition, COMP confirmed the designated orphan medicinal product status at the time of marketing authorisation of Akantior (polihexanide). ABOUT FUNGAL KERATITIS: Fungal keratitis is a severe corneal infection that often results in blindness and eye loss. The disease is most prevalent in tropical and subtropical climates. According to The Lancet, annual global incidence of fungal keratitis is estimated at 1,051,787 cases, with the highest rates in Asia and Latin America. There are no approved treatments for fungal keratitis in Europe, Japan, Asia and almost anywhere else around the World. In addition to lack of approved medical alternatives, the incidence of fungal keratitis may be on the uptick due the global trend in general resistance to anti-fungal therapeutics. 1. AAO Fungal Keratitis – Europe EPIDEMIOLOGY Contact: Sabrina Zappia +39 3336999669 [email protected]