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EP-4735040-A1 - OPHTHALMIC VISCOELASTIC DEVICE AND KIT FOR USE IN EYE SURGERY

EP4735040A1EP 4735040 A1EP4735040 A1EP 4735040A1EP-4735040-A1

Abstract

The invention relates to an ophthalmic viscoelastic device which comprises at least one viscoelastic polymer (10) that can be split into polymer chains (12) with a low molecular weight. The viscoelastic polymer (10) comprises at least two polymer chains (12) which are connected together via at least one nucleobase conjugate (14). The invention additionally relates to a kit for use in eye surgery.

Inventors

  • WOLFSTEIN, André
  • Nicoli, Francesca

Assignees

  • Carl Zeiss Meditec AG

Dates

Publication Date
20260506
Application Date
20240624

Claims (10)

  1. 1. An ophthalmic viscoelastic device comprising at least one viscoelastic polymer (10) which is cleavable into polymer chains (12) of lower molecular weight, characterized in that the viscoelastic polymer (10) comprises at least two polymer chains (12) which are linked together via at least one nucleic base conjugate (14).
  2. 2. Ophthalmic viscoelastic device according to claim 1, characterized in that the polymer chains (12) have a molecular weight between 70 kDa and 200 KDa, in particular between 76 kDa and 190 kDa, and/or that the viscoelastic polymer (10) comprises between 10 and 40, in particular between 15 and 38 polymer chains (12), which are preferably each connected to one another via at least one nucleic base conjugate (14), and/or that the polymer chains (12) have an average particle size of between 600 nm at most, in particular an average particle size of between 200 nm and 500 nm.
  3. 3. Ophthalmic viscoelastic device according to claim 1 or 2, characterized in that the at least one nucleic base conjugate (14) comprises at least one nucleic base from the group adenine, guanine, cytosine, thymine, uracil, hypoxanthine, xanthine, 7-methylguanine, 5-methylcytosine, 5-hydroxymethylcytosine and 5,6-dihydrouracil; and/or that the at least one nucleic base conjugate (14) comprises at least 3 and preferably between 3 and 30 nucleic base pairs; and/or that the nucleic base conjugate (14) comprises at least one nucleotide from DNA, RNA and PNA.
  4. 4. Ophthalmic viscoelastic device according to one of claims 1 to 3, characterized in that that the at least one nucleic base conjugate (14) consists of two nucleic base strands with the same or different number of nucleic bases; and/or that the at least one nucleic base conjugate (14) consists of two nucleic base strands, wherein the nucleic base strands comprise complementary nucleic base pairs and/or non-complementary nucleic base pairs.
  5. 5. Ophthalmic viscoelastic device according to one of claims 1 to 4, characterized in that the at least one viscoelastic polymer (10) comprises at least one formation block from the group hyaluronic acid, alginate, chitosan, methylcellulose, hydroxypropylmethylcellulose, chondroitin sulfate, collagen and gelatin.
  6. 6. Ophthalmic viscoelastic device according to one of claims 1 to 5, characterized in that the at least one viscoelastic polymer (10) comprises polymer chains (12) which are linked to one another end-to-end via the at least one nucleic base conjugate (14) and are preferably linked to one another via at least one further, non-terminal nucleic base conjugate (14).
  7. 7. Ophthalmic viscoelastic device according to one of claims 1 to 6, characterized in that the at least one viscoelastic polymer (10) has a melting temperature (Tm) between 30 °C and 35 °C, at which the nucleic bases of the at least one nucleic base conjugate (14) separate from one another; and/or that the nucleic bases of the at least one nucleic base conjugate (14) separate from one another depending on an ion concentration of a surrounding medium.
  8. 8. Ophthalmic viscoelastic device according to one of claims 1 to 7, characterized in that it is designed as a dispersive ophthalmic viscoelastic device and/or that a concentration of the at least one viscoelastic Polymer (10) based on the total volume of the ophthalmic viscoelastic device is between 0.1 mg/ml and 50 mg/ml and/or that it comprises at least one therapeutic agent, in particular an analgesic and/or an antioxidant, wherein the therapeutic agent is preferably not covalently bound to the at least one viscoelastic polymer (10).
  9. 9. Kit for use in eye surgery, comprising an ophthalmic viscoelastic device comprising at least one viscoelastic polymer (10) and at least one cleaving agent (16) by means of which the viscoelastic polymer (10) can be cleaved into polymer chains (12) of lower molecular weight, characterized in that the viscoelastic polymer (10) consists of at least two polymer chains (12) which are connected to one another via at least one nucleic base conjugate (14), and in that the cleaving agent (16) is designed to cleave the at least one nucleic base conjugate (14).
  10. 10. Kit according to claim 9, characterized in that the viscoelastic polymer (10) and the cleavage agent (16) are coordinated with one another in such a way that the cleavage agent (16) cleaves in vivo at least 70%, in particular at least 80%, of all nucleic base conjugates (14) of the viscoelastic polymer (10) within a maximum of 9 hours, in particular a maximum of 6 hours, particularly preferably a maximum of 4.5 hours; and/or that the cleavage agent (16) comprises nucleic bases which are complementary to the nucleic bases of the nucleic base conjugate (14); and/or that the cleavage agent (16) comprises at least one enzyme, in particular DNase and/or RNase, by means of which the at least one nucleic base conjugate (14) is to be cleaved and/or degraded; and/or that the splitting agent (16) comprises a buffer solution and/or Mg 2+ ions and/or Ca 2+ ions.

Description

Ophthalmic viscoelastic device and kit for use in ophthalmic surgery technical field The invention relates to a degradable ophthalmic viscoelastic device and a kit for use in an eye operation with such an ophthalmic viscoelastic device. State of the art Cataracts are a common condition, especially in the elderly, in which the lens of the eye gradually becomes opaque. This clouding of the natural lens leads to a loss of visual acuity. Cataract surgery is required to restore vision. The standard method of removing the cloudy lens nucleus to create a capsular bag for the insertion of an artificial intraocular lens (IOL) is called phacoemulsification, using a device that generates ultrasonic vibrations. Immediately before phacoemulsification, the anterior chamber is usually filled with a so-called ophthalmic viscoelastic device (OVD). The viscoelastic OVD is used as a surgical aid to protect the intraocular tissue (e.g. the corneal endothelium during phacoemulsification), as a space maintainer (e.g. to maintain the anterior chamber of the eye) and to facilitate intraocular interventions, such as performing a controlled capsulorhexis. However, such OVDs are also used in other eye operations, such as corneal transplants or glaucoma operations. OVDs are usually water-based solutions containing viscoelastic polymers such as hyaluronic acid (HA), chondroitin sulfate (CS), hydroxypropylmethylcellulose (HPMC) or mixtures thereof. The viscoelastic composition can vary by the molecular weight of the polysaccharide dissolved in the solution, by the concentration of the polysaccharide and by the viscosity of the solution. The rheological Properties depend strongly on the concentration and molecular mass of the polymers. In general, two types of OVDs are distinguished. Highly viscous, cohesive OVDs hold the space and build up pressure. They are used, for example, to dilate the pupil before the anterior capsular bag of the lens is opened (capsulorhexis). Cohesive OVDs are made of polymers with a high molecular weight. In contrast, less viscous, dispersive OVDs envelop and protect the tissue. One of the most important applications is the construction of an adherent polymer barrier with a layer thickness of about 100 pm to about 1 mm between the corneal endothelium of the anterior chamber of the eye. Disperse OVDs contain polymer chains with a lower molecular weight compared to cohesive OVDs. While a longer-chain, cohesive OVD can be easily washed out by flushing the anterior chamber with irrigation solution, shorter-chain, dispersive OVDs are much more difficult to remove or aspirate after surgery. At the end of cataract surgery, the surgeon is often faced with a layer of OVD covering the cornea and extending to the corner of the eye. An additional challenge is that the dispersive OVD material is usually located directly on the endothelium, where it is generally difficult to aspirate, and in the corner of the eye, where it is also difficult to see. Residues of OVD that remain in the eye after surgery can be gradually washed out by the aqueous humor and transported away via the trabecular meshwork. However, polymer chains that are too long can partially block the trabecular meshwork and delay or completely prevent removal. This can then lead to increased intraocular pressure (IOP) after surgery. However, increased intraocular pressure represents a risk for the patient as it can lead to glaucoma. representation of the invention The object of the present invention is to provide an ophthalmic viscoelastic device for use in eye surgery, which reduces the risk of an increase in intraocular pressure after eye surgery. A further object of the invention is to create a correspondingly advantageous kit with an ophthalmic viscoelastic device. The object is achieved according to the invention by an ophthalmic viscoelastic device according to claim 1 and by a kit according to claim 9 for use in an eye operation. Advantageous embodiments with expedient embodiments of the invention are specified in the subclaims, wherein advantageous embodiments of each aspect of the invention are to be regarded as advantageous embodiments of the other aspect of the invention. A first aspect of the invention relates to an ophthalmic viscoelastic device comprising at least one viscoelastic polymer which can be split into polymer chains with a lower molecular weight. According to the invention, the risk of an increase in intraocular pressure after eye surgery is reduced in that the viscoelastic polymer comprises at least two polymer chains which are connected to one another via at least one nucleic base conjugate. In other words, the invention provides that the at least one viscoelastic polymer consists of two or more polymer chains, with at least two of these polymer chains and preferably the majority or all of the polymer chains each being connected to one another via at least one nucleic base conjugate. In the context of the present disclosure, a nucleic