Dosing regimens
In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
1. A method of treating a subject in need of treatment for a complement-mediated eye disorder, the method comprising intravitreally administering about 15 mg of a long-acting compstatin analog (LACA) monthly or every other month to the eye of the subject, wherein
(a) the LACA comprises a PEG having an average molecular weight of 40 kD attached to two compstatin analog moieties, wherein
each compstatin analog moiety comprises a cyclic peptide having the amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue at the C-terminus, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer;
wherein each end of the PEG is linked to the amino group of the side chain of the lysine residue of one of the compstatin analog moieties by way of a carbamate; and
(b) the complement-mediated eye disorder is geographic atrophy.
2. The method of claim 1 , wherein the LACA is administered intravitreally monthly.
3. The method of claim 1 , wherein the LACA is administered intravitreally every other month.
4. The method of claim 1 , wherein the LACA is administered using a 25, 26, 27, 28, or 29 gauge needle.
5. The method of claim 4 , wherein the needle is a thin-walled needle.
6. The method of claim 1 , wherein the LACA comprises the compound
7. The method of claim 1 , comprising administering the LACA to the subject in the form of a composition comprising the LACA at a concentration of from about 100 to about 200 mg/mL.
8. The method of claim 7 , comprising administering the LACA to the subject in the form of a composition comprising the LACA at a concentration of about 150 mg/mL.
9. The method of claim 1 comprising administering the LACA to the eye of the subject in a volume of from about 90 to about 150 μL.
10. The method of claim 9 , comprising administering the LACA to the eye of the subject in a volume of about 100 μL.