ATHENS, Greece—RAFARM, a Greek-based pharmaceutical company and established European manufacturer with expertise in ophthalmics, and BioNanoSim (BNS), an Israeli-based nanotechnology drug discovery and development company co-founded by professor Simon Benita and Yissum, the Transfer Technology and IP company of The Hebrew University of Jerusalem, have entered into an agreement to create a new ophthalmic company called BNS Ophthalmics (BNSO). BNSO will develop, manufacture and commercialize a range of innovative ophthalmic pharmaceutical products developed by BioNanoSim to address serious ophthalmic unmet needs for patients around the world.

Over the past five years, BNS has developed the proprietary nano-technology platform (NTPO). The first product developed by BNSO according to this technology is BNSO-1, a Tacrolimus ocular emulsion for topical ocular administration of conditions such as uveitis.

Tacrolimus is a potent non-steroidal drug with the potential to treat a wide range of serious ocular inflammatory conditions, but is highly unstable, insoluble in water, and does not permeate through the cornea. BNSO-1 demonstrates clear efficacy and safety in preclinical models. BNSO is on track to initiate a phase I/IIa clinical study before the end of 2023 in patients suffering from Chronic Anterior Uveitis. 

BNS has received FDA orphan designation for this indication and expects an accelerated 505b2 regulatory approval track assuming clinical results are positive. BNSO has two additional preclinical programs in its pipeline, both invented by Benita and developed by BNS. The first is an innovative delivery technology enabling a prolonged release intravitreal injection of a steroid derivative drug (without any impact on the intra ocular pressure) for Macular Edema and Age-related Macular Degeneration [BNSO-2].
The second program is a novel topical drug for dry eye disease [BNSO-3]. Together, BNSO’s programs target multibillion dollar global market opportunities, the announcement said.

BNS will contribute its intellectual property and R&D expertise to BNSO while Rafarm will provide appropriate funding, together with infrastructure for development, commercial scale manufacturing and distribution.
Benita, professor emeritus at The Hebrew University of Jerusalem, founder, CEO and chairman of ΒΝS, stated, “We are very pleased to partner with RAFARM and to leverage both organizations’ expertise and infrastructure for promoting improved therapeutic options in the ocular area. At BNS, we synthesize new chemical entities and develop innovative delivery approaches to address some of health care’s greatest challenges. BNSO will use our proprietary carrier technologies to improve the delivery, stability and bioactivity of drugs in multiple ocular segments.”
Commenting on the partnership, Aris Mitsopoulos, vice president of RAFARM, added,“We are very proud of the establishment of BNS Ophthalmics, a company that enhances RAFARM’s capabilities in innovation and contributes to cover unmet therapeutic needs in ophthalmology. Our collaboration with BNS, whom we recognize as a leader in the field of nanotechnology, marks a significant milestone of RAFARM in innovative technologies. We join forces with BNS for the development and production of novel therapeutic products and to further expand our expertise in ophthalmics.”